litigios en anestesia regional

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O R I G I N A L A RT I C L E

Litigation related to regional anaesthesia: an analysis of claims against the NHS in England 19952007*

K. Szypula, 1 K. J. Ashpole, 2 D. Bogod, 3 S. M. Yentis, 4 R. Mihai, 5 S. Scott 5

and T. M. Cook 6

1 Specialist Trainee and 3 Consultant, City Hospital Campus, Nottingham University Hospitals NHS Trust,Nottingham, UK 2 Locum Consultant and 4 Consultant, Magill Department of Anaesthesia, Chelsea and Westminster Hospital NHS Foundation Trust, London, UK 5 Consultant, Department of Anaesthesia, John Radcliffe Hospital, Oxford, UK 6 Consultant, Department of Anaesthesia, Royal United Bath Hospital, Bath, UK

Summary

We analysed 366 claims related to regional anaesthesia and analgesia from the 841 anaesthesia-related claims handled by the National Health Service Litigation Authority between 1995 and2007. The majority of claims (281 366, 77%) were closed at the time of analysis. The total cost of closed claims was 12 724 017 (34% of the cost of the anaesthesia dataset) with a median (IQR[range]) of 4772 (028 907 [02 070 092]). Approximately half of the claims (186 366; 51%)were related to obstetric anaesthesia and analgesia and of the non-obstetric claims, the majority(148 180; 82%) were related to neuraxial block. The total cost for obstetric closed claims was5 433 920 (median (IQR [range]) 5678 (027 690 [01 597 565]) while that for non-obstetric closed claims was 7 290 097 (3337 (031 405 [02 070 062]). Non-obstetricclaims were more likely to relate to severe outcomes than obstetric ones. The maximum valuesof claims were higher for claims related to neuraxial blocks and eye blocks than for peripheralnerve blocks. Despite many limitations, including lack of clinical detail for each case, the datasetprovides a useful overview of the extent, patterns and cost associated with the claims.

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Correspondence to: Dr K. SzypulaE-mail: [email protected]*Presented in part at the Regional Anaesthesia Great Britain and Ireland Annual Meeting, London, May 2008; the Obstetric Anaesthetists Association Annual Meeting, Belfast, May 2008; and the European Society of Regional Anaesthesia Annual Meeting,Genoa, September 2008. Accepted: 28 December 2009

The use of regional anaesthesia and analgesia (both centralneuraxial and peripheral techniques) has become routinepractice, both for surgical and obstetric procedures. Suchtechniques may be associated with multiple benetswhether used as an alternative or in addition to generalanaesthesia, including superior postoperative analgesia andpotentially reduced morbidity and mortality [15].Complications resulting from various regional techniqueshave been well described [69], and studies of insurance

claims related to regional anaesthesia in Canada, Finlandand the USA have been published, with detailed analysisof specic patterns of injury and legal liability [1013].Similar information regarding UK practice is lacking, andto the best of our knowledge the pattern of litigationrelated to regional anaesthesia and analgesia in the UK hasnot been reported before.

The National Health Service Litigation Authority(NHSLA) is a Special Health Authority responsible for

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handling both clinical and non-clinical negligence claimson behalf of the NHS bodies in England. Their ClinicalNegligence Scheme for Trusts (CNST) is a voluntary riskpooling scheme to which all NHS Trusts in Englandcurrently belong. The NHSLA database contains detailsof clinical claims where the allegedly negligent incidenttook place on or after 1 April 1995, although before 2002some minor claims were managed by hospitals locallywithout notication to the NHSLA.

This study analyses all claims from the NHSLA databaserelated to regional anaesthesia and analgesia that occurredbetween 1995 and March 2007. The aims of the analysiswere to highlight areas of high litigation risk and to reportthe nancial impact of the claims. We also brieycompare the differences between neuraxial blocks placedfor obstetric and non-obstetric indications.

Methods

Data on negligence claims related to anaesthesia wererequested and obtained from the NHSLA in May 2007,via their freedom of information portal. These includedall clinical negligence claims notied to the CNST thatoccurred between April 1995 and March 2007 led under anaesthesia. A detailed description of the data review andclassication process has been previously reported [14]. Inbrief, the data returned were in the form of ananonymous spreadsheet that included information onthe nancial year of the incident and the claim, whether the case was open (ongoing) or closed (settled or withdrawn), a brief clinical description of the case, thecost to the NHS of the claim, and the specialties involvedin the claim. The dataset also contained a classication of the cause of the incidents, the injury type and the locationof the incident, but these were found to be inconsistentand therefore unreliable so were not used in sorting or subsequent analyses. The clinical details available for eachclaim were very limited. Further clinical information wasrequested from the NHSLA, but was not available for anyclaim.

The cost associated with a closed claim as described inthe NHSLA database is the cost of defending a claim,including legal fees (both claimant and defence) and the

cost of any settlement, but excluding the cost of theNHSLA itself. The dataset did not contain the informa-tion required to determine the proportions of claimssuccessfully defended, or settled in or out of court.Neither were the proportions of claim cost allocated tolegal fees and patient settlement available. All nancialsettlements, unless stated otherwise, were adjusted usingthe Retail Price Index to 2006 monetary values (the year of the most recent closed claim in the dataset) so that

settlements in different years could be directly comparedwith each other [15].

Each claim was initially analysed independently bythree investigators (TC, RM, and SS), in order to classifycases according to clinical category and severity. Claimsthat were clearly not related to anaesthesia, and thosethat were related purely to intensive care or managementin a pain clinic, were excluded from further analysis.Claims with too little clinical detail for any usefulinterpretation were also excluded. The remainingclaims were subdivided into a number of non-exclusivecategories including obstetric anaesthesia (includinganalgesia), regional anaesthesia, inadequate anaesthesia,drug-related excluding allergy, drug allergy, centralvenous cannulation, peripheral venous cannulation,consent problems, positioning problems and miscella-neous. Each case was also assigned a severity score, basedon the NPSA tool for grading severity of patient

incidents (Appendix 1) [16]. Due to lack of detail inclinical descriptions, two intermediate severity categorieswere added: mild moderate and moderate severe. Theresults of the independent assessments by the threeinvestigators were then combined. If there was disagree-ment regarding inclusion, category or severity score, thecase was discussed further until agreement was reached.Further investigators were recruited to analyse individualclinical categories, and a nal dataset was agreed in April2008.

It is important to appreciate that the NHSLA databaseis not a clinical or risk database, but was set up for claimand nancial management, with very limited clinicaldetail available. The detailed examination of each claimand exclusions as described aimed to improve the qualityand robustness of the data available to us.

The type of regional block involved and the basis of theclaim were obtained from the brief description of theincident. The authors sorted the claims into clinicalcategories according to the major damaging event asdescribed in the clinical description (Appendix 2). Incases where two or more damaging events were evident,the claim was categorised under the most seriouscomplaint.

Claims in the regional anaesthesia category, obstetric

and non-obstetric, were analysed both quantitatively andqualitatively. The quantitative analysis was performed todetermine the cost associated with regional anaesthesiaclaims. The qualitative assessment was performed in anattempt to highlight areas of clinical practice that might beconsidered of high medicolegal risk. MICROSOFT EXCEL(Version 5.0; Microsoft Corporation, Redmond, WA,USA) was used throughout the project, and data wereanalysed using simple descriptive statistical tests.

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Results

The NHSLA database contained 1067 reports. In total226 cases were removed from further analysis, becausethey were clearly not anaesthesia-related or containedinadequate information ( n = 196), or were related purelyto intensive care ( n = 13) or pain clinics ( n = 17). Thenal dataset contained 841 anaesthetic claims. Regionalanaesthesia was the single largest clinical category in thedataset with 366 (44%) claims, of which 186 (51%) wereobstetric and 180 (49%) non-obstetric. Of the 366 casesincluded in this analysis, 281 366 (77%) were closed atthe time when the data were provided.

The severity of claimed outcome and cost of the claimsis reported in Table 1. Compared to the whole anaes-thesia dataset regional anaesthesia contains a somewhathigher percentage of claims of severe outcome, but fewer claims of a fatal outcome [14].

Table 2 shows the types of regional block cited inclaims relating to regional anaesthesia and analgesia. Themaximum cost of claims was higher for those related toneuraxial and eye blocks compared with peripheral nerveblocks.

The total cost associated with regional anaesthesia was12 724 017, with a median (IQR [range]) of 4772

(028 907 [02 070 092]). Fatal outcome was asso-ciated with the highest median cost, but the maximumcost of a claim relating to a severe outcome was more than10 times the highest cost of a fatal outcome (Table 1).Closed claims associated with a severe outcome ac-counted for fewer than 20% of closed claims but almosthalf their cost. There were 28 claims with an associatedcost above 100 000 (Table 3); 26 followed neuraxialblockade, of which 9 (35%) were obstetric and 17 (64%)non-obstetric. Table 4 demonstrates trends in the cost of claims per year. Ninety-two percent of cases (338) werenotied to the NHSLA within 3 years of the incident and99% (362) within 4 years.

Table 5 shows the frequency of the damaging eventsfor the 366 regional anaesthesia claims. Of the 326neuraxial claims, 264 (81%) were related to epidurals.Overall, the most frequent damaging event was nervedamage (76 claims), followed by inadequate block with

resulting pain (24 claims), and back pain (24 claims).Other damaging events included: injury related tosensory block, such as burns and pressure sores (23 claims);dural tap (18 claims); epidural haematoma (eight claims);drug error (eight claims); and high block hypotension(eight claims). There were 17 claims related to infection,including epidural abscess (seven claims), spinal abscess

Table 1 Distribution of severity in claims reported to the NHSLA (19952007) relating to regional anaesthesia or analgesia. Values arenumber (proportion) or median (IQR [range]).

Severi ty of outcome ClaimsClosedclaims

Claims leadingto cost

Totalcost; 000 Cost per case; 000

Death 8 (2%) 7 (88%) 6 (86%) 420 42 (399 [0178])Severe 68 (19%) 50 (74%) 37 (74%) 6313 6 (073 [02070])Moderate severe 17 (5%) 9 (53%) 7 (78%) 651 3 (1149 [0337])Moderate 83 (23%) 61 (73%) 46 (75%) 2190 8 (060 [0184])Mild Moderate 74 (20%) 60 (81%) 41 (68%) 1262 2 (021 [0376])Mild 102 (28%) 85 (83%) 45 (53%) 1015 1 (015 [0171])Unclassied 14 (4%) 9 (64%) 6 (67%) 873 8 (031 [0782])Total 366 (100%) 281 (77%) 188 (67%) 12 724 5 (0 29 [02070])

Table 2 Claims reported to the NHSLA (19952007) relating to regional anaesthesia or analgesia, according to the type of block.Values are number (proportion) or median (IQR [range]).

Type of block Claims Closed claimsClosed claimsleading to cost Total cost; 000 Cost per claim; 000

Epidural 264 (72%) 206 (78%) 131 (64%) 8074 2 (023 [02070])Spinal 54 (15%) 38 (70%) 26 (68%) 3016 14 (041 [01598])CSE 8 (2%) 8 (100%) 7 (88%) 958 82 (6269 [0376])Eye 12 (3%) 10 (83%) 8 (80%) 361 24 (733 [0184])Upper limb 6 (2%) 2 (33%) 2 (100%) 1 0.5 [01]Lower limb 4 (1%) 4 (100%) 2 (50%) 116 6 (058 [0105])Paravertebral 1 0 N A N A N ASplanchnic 1 0 N A N A N AUnspecied 16 (4%) 13 (81%) 12 (92%) 199 7 (321 [078])

CSE, combined spinal-epidural anaesthesia

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(two claims), meningitis (two claims) and other infection(ve claims). Of the 54 (17%) claims related to spinalanaesthesia, the three most frequent damaging eventswere inadequate block (21 claims), nerve damage (13claims), and drug error (three claims). Seven out of theeight claims related to combined spinal-epidural anaes-thesia (CSE) were of alleged nerve damage.

Of the 12 (3%) claims arising from ophthalmic regionalanaesthesia, globe perforation was the damaging event in10 cases, with resultant loss of vision and or need for further surgery.

The six (2%) claims arising from upper limb regionalanaesthesia comprised intravenous injection (two claims),pneumothorax (two claims), neurological damage (one

Table 3 Closed claims with cost exceeding 100 000 in 366 claims reported to the NHSLA (19952007) relating to regionalanaesthesia or analgesia. Values are actual amounts. Obstetric cases are indicated by *.

Year of claim Cost; 000 Clinical details

1999 2000 2070 Spinal haematoma in relation to epidural analgesia for bowel surgery, leading to paraplegia2000 2001 1598 Needle inserted into wrong position during spinal anaesthesia for removal of retained placenta*2000 2001 782 Neurological damage following epidural for knee replacement2000 2001 597 Cardiac arrest and brain damage following epidural local anaesthetic overdose2001 2002 398 Paraplegia following labour epidural analgesia*1998 1999 376 Neurological damage fol lowing CSE*2001 2002 337 Neurological damage following spinal anaesthesia1999 2000 269 Pain and weakness in leg and back following damage to nerve roots during epidural via needle

through needle technique*2002 2003 269 Epidural morphine overdose1997 1998 251 Spinal cord damage following cervical epidural2004 2005 184 Globe perforation during peribulbar block2000 2001 178 Epidural haematoma leading to paraplegia1999 2000 171 Difcult failed spinal1999 2000 166 Spinal infarct after prophylactic saline infusion for dural puncture following labour epidural*2001 2002 165 Epidural haematoma leading to paraplegia1998 1999 159 Epidural analgesia for laparotomy. Pressure sore on heel and permanent nerve lesion1997 1998 143 Spinal anaesthetic complicated by cord damage, leading to permanent disability*

2002 2003 142 Delay in diagnosis of epidural ulcer2002 2003 139 Pain during hysterectomy under spinal anaesthesia1997 1998 133 Spinal abscess complicating epidural insertion, leading to permanent disability2001 2002 130 Labour epidural complicated by dural puncture, leading to ongoing backache and hearing problems*1999 2000 130 Nerve damage following spinal anaesthetic for elective caesarean section*1999 2000 129 Temporary paralysis in relation to epidural anaesthesia for hiatus hernia repair2000 2001 120 Nerve damage during CSE*2000 2001 108 Nerve root trauma during CSE, resulting in persistent pain and hypersensitivity1999 2000 105 Nerve damage after femoral sciatic block for knee replacement, leading to permanent disability2001 2002 101 Cervical epidural complicated by dural puncture and cord damage2002 2003 100 Neurological damage following epidural for arterial bypass

CSE, combined spinal-epidural anaesthesia

Table 4 Claims reported to the NHSLA (19952007) relating to regional anaesthesia or analgesia, according to the year of theincident. Values are number (proportion) or median (IQR [range]).

Year ClaimsClosedclaims

Closed claimsleading to cost Total cost; 000 Cost per claim; 000

1995 1996 18 17 (94%) 13 (76%) 925 6 (038 [0376])1996 1997 20 19 (95%) 17 (89%) 1563 44 (2142 [0269])1997 1998 20 19 (95%) 16 (84%) 660 9 (047 [0178])1998 1999 34 33 (97%) 24 (73%) 2823 14 (040 [02070])1999 2000 39 38 (97%) 30 (79%) 3534 5 (032 [01598])2000 2001 37 33 (89%) 19 (58%) 1306 2 (027 [0597])2001 2002 54 45 (83%) 28 (62%) 1091 5 (015 [0337])2002 2003 48 36 (75%) 23 (64%) 413 3 (014 [075])2003 2004 51 28 (55%) 15 (54%) 338 1 (013 [0184])2004 2005 27 11 (41%) 2 (18%) 58 0 (00 [042])

2005 2006 16 2 (13%) 2 (100%) 15 8 ([214])




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claim) and infection from an indwelling axillary catheter (one claim). The four (1%) claims arising from lower limbblocks all related to neurological damage.

There were 12 claims in which fatality was recorded asthe coded injury sustained. This equates to approximatelyone claim related to death in this group, each year. Elevenclaims cited an epidural and one an eye block. All deathswere related to non-obstetric regional anaesthesia. After consideration of the limited description of the incidents,outcome was classied as death only if the investigatorsconsidered that the death was a direct consequence of theincident. This resulted in eight of these 12 outcomesclassied as death, three as severe, and one asmild moderate.

The number (proportion) of claims leading to cost wassimilar for obstetric (103 186; 55%) and non-obstetric(85 180; 47%) claims, respectively. The total cost for obstetric closed claims was 5 433 920 (median (IQR

[range]) 5678 (027 690 [01 597 565]) and for non-obstetric closed claims, 7 290 097 (3337 (031405 [02 070 062]). Neuraxial block accounted for allof the obstetric claims and 148 180 (82%) non-obstetricclaims of claims. In 8 186 (4%) of the obstetric claims theexact type of block involved was indeterminate. Non-obstetric neuraxial claims were more likely to relate tosevere outcomes than obstetric ones. Tables 57 providean overview of the differences between the obstetric andnon-obstetric claims.

The most frequent damaging events for the obstetricneuraxial claims were inadequate block (pain duringcaesarean section or labour) (57 claims), nerve damage (39claims) and back pain (19 claims); for the non-obstetricclaims these were nerve damage (58 claims), infection(16 claims) and drug error (10 claims).

Discussion

The principal nding of this analysis of claims in theNHSLA dataset relating to regional anaesthesia andanalgesia is that they are responsible for 44% of claimsand a similar proportion of the cost of the overallanaesthesia dataset. Eighty-nine per cent of the claimsinvolve neuraxial blocks, predominantly epidurals.

Our analysis has a number of limitations. A detailedaccount of these limitations is provided elsewhere [14]. Aspreviously noted, the function of the NHSLA database isto allow nancial management of claims, and the clinicalinformation available for each case is therefore severelylimited. The clinical information is a very brief account of the alleged incident and lacks verication of actual clinicaldetails and outcome, as well as characteristics of thepatient and their ASA and CEPOD status. Inclusion inthe database does not mean that the described clinical

events are accurate. We found the NHSLA coding of typeof injury, location and speciality to be of little value; inmany cases it did not correlate with the clinical descrip-tion. More than 10% of cases were misclassied asanaesthesia, which raises the question of how manyclaims actually related to anaesthesia were also misclassi-

ed and therefore not included in the dataset provided tous. The data available on the cost of claims included thecost of claimant as well as defence legal services, but notthe cost of the NHSLA itself, and we were unable toobtain the breakdown of cost into legal fees and patientawards, nor determine the proportion of cases whichwere settled out of court. The NHSLA database does notcontain any denominator data, nor any details of adverseevents that did not lead to initiation of a claim. As a result,estimates of risk of litigation for regional anaesthesia in

Table 5 Damaging events (proportion) in 366 claims reportedto the NHSLA (19952007) relating to regional anaesthesia or analgesia.

All claimsn = 366

Non-obstetricn = 180

Obstetricn = 186

Nerve damage 105 (29%) 66 (37%) 39 (21%)Pain* 63 (17%) 6 (3%) 57 (31%)Back pain 26 (7%) 7 (4%) 19 (10%)Injury related to

sensory block23 (6%) 7 (4%) 16 (9%)

Dural tap 20 (5%) 9 (5%) 11 (6%)Infection 18 (5%) 17 (9%) 1Drug error 13 (4%) 10 (6%) 3 (2%)Globe perforation 10 (3%) 10 (6%) N AEpidural haematoma 8 (2%) 8 (4%) 0Injury related to

motor block7 (2%) 3 (2%) 4 (2%)

Indeterminate 25 (7%) 7 (4%) 18 (10%)Other 48 (13%) 30 (17%) 18 (10%)

*Including intra-operative pain, pain during labour, and postopera-tive.Including epidural abscess, spinal abscess, meningitis, sepsis, woundinfection and other.

Table 6 Severity of outcome in 334 claims reported to theNHSLA (19952007) relating to neuraxial regional anaesthesiaor analgesia. Values are number (proportion).

Obstetricn = 186

Non-obstetricn = 148

Death 0 8 (5%)Severe 19 (10%) 37 (25%)

Moderate severe 5 (3%) 11 (7%)Moderate 41 (22%) 31 (21%)Mild Moderate 49 (26%) 23 (16%)Mild 67 (36%) 30 (20%)Unclassied 5 (3%) 8 (5%)




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general or for specic regional anaesthesia procedurescannot be made directly from these data. Our analysis islikely to underestimate the number of regional anaesthesiacases in the dataset since, unless there was clear evidence

that a case was related to regional anaesthesia, it wasexcluded from our analysis. Finally, over the 11-year database period, there have been changes in anaestheticpractice and standards.

Despite the above limitations, analysis of the NHSLAclaims related to regional anaesthesia or analgesia isvaluable, by disclosing the type of regional blockinvolved, the severity and the nancial risk of such claimsin the NHS in England. It is potentially useful at variousorganisational levels. Firstly, by highlighting areas of apparently high medicolegal risk, it may help professionalorganisations, including trusts and those who advise them,to direct development of guidelines regarding safepractice and risk avoidance. Secondly, it is potentiallyvery useful to individual clinicians, by demonstrating thetype of cases that lead to medicolegal claims, and thenature of those claims. For example, the fact that almost10% of claims included allegations of lack of consent mayact as an impetus to anaesthetists to consider how best todeliver and document information about the risks andbenets of regional blocks [17].

In general terms, there was a tendency for cost to risewith increased severity. This is in keeping with expec-tations, and suggests that our assessment of severity wasnot grossly inaccurate for the regional anaesthesia claims

[14]. However, caution is needed when assuming a closecorrelation between cost and severity of damage. Whilethe award to the patient might reasonably be expected toreect the harm that they have experienced, the far fromtrivial legal cost component of the overall sum is oftenrelated to whether the negligence claim proceeds to a fullhearing or is settled out of court. This is more likely todepend on the merits of the claim, specically whether there is clear failure of duty of care and causation, rather than being related to degree of harm. Overall the NHSLA

spends slightly more on legal fees (51% in 2007) than onpatient settlements (49%) [18].

Regional anaesthesia accounts for the largest number of claims in the full anaesthesia dataset (44%), and, of these

claims, approximately half are obstetric. Regional anaes-thesia is also the group with the highest overall cost.However, it does not have the highest cost per claim; thegroups with the highest mean cost per claim arerespiratory, central venous cannulation and drug error excluding allergy [14]. These data cannot provide anestimate of risk of litigation due to the lack of denom-inator data. While it is not known how many anaestheticsare administered in the UK or in England per year it hasbeen estimated that 7.28 million surgical procedures arecarried out in England each year (http://www.npsa.nhs.uk/corporate/news/safe-surgery-saves-lives/ (accessed22 04 2009)) [19], and the 3rd National Audit Projectof the Royal College of Anaesthetists (NAP3) hasestablished that approximately 700 000 neuraxial blocksare performed in the NHS in the UK each year [6]. Thesedata strongly suggest that the number of claims related toregional anaesthesia is disproportionately high.

The results may be taken to suggest that there is adecrease in the number of claims for the years 2003onwards. However, the time from the incident occurringto claim notication was up to 10 years. Only 10% of claims were registered within 1 year of the incident, and8% were registered more than 3 years after the incident.Therefore data for the years 2003 onwards are almost

certainly incomplete, and very unlikely to reect a truedownward trend. Indeed, the broader NHSLA datasuggest that the number of claims is probably increasing[18].

The review of the Canadian Medical ProtectiveAssociation claims for the period 19901997, by Pengand Smedstad, identied 310 cases involving anaesthetists,of which 61 cases (20%) were related to (obstetric andnon-obstetric) regional anaesthesia [10]. The authorsreported that approximately two thirds of closed claims

Table 7 Claims reported to the NHSLA (19952007) relating to neuraxial anaesthesia or analgesia, according to the type of block.Values are number (proportion) or median (IQR [range]). Claims with indeterminate type of block ( n = 16) have been excluded.

Type of block Claims Closed claimsClosed claimsleading to cost Total cost; 000 Cost per claim; 000

Obstetric Epidural 139 (78%) 115 (83%) 75 (65%) 2198 3 (028 [0398])Spinal 35 (20%) 23 (66%) 17 (74%) 2322 20 (045 [01598])CSE 4 (2%) 4 (100%) 4 (100%) 822 195 (104-322 [56376])Total 178 (100%) 142 (80%) 96 (68%) 5342 5 (028 [01598])

Non-obstetric Epidural 125 (84%) 91 (73%) 56 (62%) 5876 2 (035 [02070])Spinal 19 (13%) 15 (79%) 9 (60%) 694 2 (037 [0337])CSE 4 (3%) 4 (100%) 3 (75%) 136 14 (14-18 [0108])Total 148 (100%) 110 (74%) 68 (62%) 6706 2 (035 [02070])




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were related to neuraxial blockade ( n = 42), with eyeblocks the most commonly cited peripheral nerve block(n = 7 19), accounting for 12% of all regional claims.There were no deaths in the regional anaesthesia group.

In a review from the American Society of Anesthesi-ologists Closed Claims Project (ASACCP), Lee et al. [12]reviewed injuries associated with regional anaesthesia for the period 19801999. Of 5047 claims in that period, justunder 20% ( n = 1005) were related to regional anaesthe-sia and analgesia, including obstetrics. Of the neuraxialanaesthesia claims, 368 (45%) cases were obstetric and 453(55%) non-obstetric. Of the 453 non-obstetric neuraxialanaesthesia claims, 143 (32%) led to death brain damage,117 (26%) to permanent nerve injury and 172 (38%) totemporary nerve injury. Peripheral nerve blocksaccounted for 13% of all regional anaesthesia claims, and21% of the non-obstetric claims, while regional anaes-thesia of the eye (45 1005) accounted for 4% of all

regional anaesthesia claims.In the NHSLA dataset, claims relating to eye blocks

represented 3% (12 366) of regional anaesthesia claims,comparable to the ASACCP data, but signicantly lessthan in the Canadian dataset. In the North Americanreviews retrobulbar and peribulbar blocks had been usedin the majority cases. During the period of the NHSLAdataset it is likely that such blocks have decreased with acommensurate increase in sub-Tenons blocks and topical(eye-drop) anaesthesia. While these techniques might beanticipated to lead to a reduction in the number of complications and negligence claims [20], with seven of 12 claims occurring in the second half of the dataset thereis no evidence of such an effect to date.

Compared to these two North American anaesthesiadatasets the data presented here have approximately twicethe proportion of claims relating to regional anaesthesia.This may reect a greater reliance on regional blocks inUK practice. Of note, the North American analyses cover an earlier period than the NHSLA data and the use of regional anaesthetic and analgesic techniques has probablyincreased in the early years of the 21st century, due togreater appreciation of the benets of these techniques[21] and the development of new techniques for successful siting of regional blocks [22]. The different

legal systems might also contribute to this discrepancy: inthe USA litigation with low value claims (e.g. < $50 000)is less likely to be encouraged in the no-win no feesystem, while in England, where all legal costs aresometimes provided by the state, the likelihood of lowvalue claims is perhaps increased [23]. As the regionalanaesthesia group contains a relative excess of lowseverity, low value claims, this group would be mostaffected by such a trend.

Claims arising from obstetric neuraxial regional anaes-thesia were associated with a lower proportion of severeinjuries and death than non-obstetric claims and moremild-moderate injuries (Table 6). Despite similar num-bers of claims in the two subsets, the total cost was lower in the obstetric group, due to a larger number of claimsrelated to lower severity harm. A similar picture is seen inthe obstetric claims in the ASACCP, where the majorityof claims were also less severe [13]. This highlights theimportance of tackling relatively small events incidents aswell as major ones in order to reduce the nancial burdenof obstetric anaesthetic claims on the NHS. The distri-bution of the type of regional anaesthesia involved wassimilar in the obstetric and non-obstetric groups. Inad-equate regional anaesthesia leading to pain during surgeryor labour was the most common damaging event in theobstetric group with 57 (31%) claims; in comparison therewere only two cases with intra-operative pain as the main

damaging event in the non-obstetric group. Pain duringcaesarean section under regional anaesthesia was classiedas mild or moderate (where post-traumatic stressdisorder was cited) harm and these cases in particular contribute to the high frequency of low severity claimsseen with obstetric anaesthesia. The relatively largeproportion of claims relating to pain during caesareansection suggests a need to improve intra-operativemanagement of regional anaesthesia for these. The cost(and, we speculate, the settlements) associated with thesecond most frequent damaging event, nerve injury, wasconsiderably greater than the cost associated with inad-equate anaesthesia. There was a wide spectrum of claimedinjury, from paraesthesia and mild injuries to cases of paraplegia. Nerve injury (most being temporary and or non-disabling) is now the most frequent damaging eventin the ASACCP for obstetric anaesthesia [13], havingpreviously been the third commonest cause [24]. Notablyonly a third of ASACCP claims relating to nerve injuryreceived payments, compared with over three-quarters of similar NHSLA closed claims.

In the ASACCP, the most frequent cause of maternaldeath between 1990 and 2003 was high neuraxial block,accounting for 22% of maternal deaths in the obstetricdataset overall and 37% of deaths related to regional

anaesthesia [11]. The majority (80%) were epidural related(10 accidental intrathecal catheters and two high blocks).The NHSLA dataset included no deaths associated withhigh obstetric regional anaesthetic blocks, though in thelast four Condential Enquiries into Maternal Deathstriennial reports there were two direct anaesthetic deathsrelated to high neuraxial blocks: one following a CSE inthe 19941996 report and one epidural in the 19971999report [2528].




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Recently, NAP3 has helped to dene the risks of neur-axial blockade and has also provided robust denominator data on the number of neuraxial blocks performed in theNHS in the UK [6]. The results of NAP3 have beendescribed, by its authors (one also an author of this paper),as largely reassuring. Out of the 700 000 cases, thepessimistic point estimate of incidence of permanentinjury was 1 in 24 000 and of paraplegia or death was 1 in55 000. Of note, peri-operative epidurals were associatedwith the highest incidence of adverse sequelae (with pointestimates of between 1 in 6000 and 1 in 12 000). In theNHSLA dataset, epidural block was responsible for morethan two-thirds of all claims; but, due to limited clinicaldata, we were unable to determine the proportion of claims related to permanent nerve damage or paraplegia. Itis also possible that the term epidural has been usedgenerically for other procedures such as spinal, caudal or CSE techniques: this would articially increase the

proportion of claims led under epidural. Spinalsaccounted for over 40% of neuraxial blocks in NAP3,and yet there were only 54 (15%) claims related to spinalanaesthesia in the current dataset. This suggests that spinalanaesthesia is a procedure associated with a relatively lowrisk of litigation.

There is much current interest in wrong-route errors inneuraxial block and their potential solutions. NAP3highlighted nine cases (six in obstetrics) of wrong-routeinjection errors, where a drug planned for neuraxialadministration was accidentally injected intravenously, or vice versa. There was one clear wrong-route error involving the wrong drug administered into an epiduralcatheter (in obstetric theatre recovery) and three othersthat may have been wrong-dose or wrong-route errors(one theatre based and two ward-based, all non-obstetric)[29]. There were no claims relating to accidentalintravenous administration of epidural drugs, nor of thewrong drug given intrathecally. This small number of wrong-route claims contrasts markedly with recentreports [6, 30]. Surveys of lead obstetric anaesthetists inthe UK suggest that drug errors are relatively common[30, 31], with almost one in four UK obstetric unitssurveyed in September 2006 having knowledge of arecent wrong-route error in their department [30]. This

mismatch between errors and litigation may be explainedby incorrect classication of claims but, if this is not so,other possibilities are that few patients involved in suchincidents are harmed or that disproportionately fewproceed to litigation. Recent events make this unlikelyto be sustained.

The current dataset highlights some high medicolegalrisk areas where claims may be avoidable, but, with thelimited clinical data, a detailed analysis of system andhuman factors is not possible. However, in many areas it

is evident there are potential solutions to reduce risk of patient harm and litigation. Examples include: appropriateinformed consent for regional anaesthesia with docu-mentation of the risks discussed; improved intra-operativecare to eliminate pain from inadequate regional anaes-thesia (particularly in obstetric practice); and perhapsimproved postoperative surveillance to prevent, or allowearly active management of, sequelae. Drug errors may bereduced by improvements both in design of deliverysystems and systems for drug checking.

While analysis of the present data has enabled docu-mentation of the broad patterns of litigation in this area,the quality of the data on which the analysis is basedprevents both genuine closed claim analysis and rootcause analysis. A communication pathway between theNHSLA (and other UK-based bodies) and anaesthetiststhat improved the extent and quality of review of thesecases would enable detailed analysis of claims and better

identication of patterns resulting from system error, andenable resultant change in practice to minimise patientharm and litigation. This would logically be benecial for clinicians, the NHSLA itself and ultimately for patients.

In conclusion, we have examined the existing data heldby the NHSLA on claims related to regional anaesthesiain England. The dataset provides an overview of theextent, patterns and cost associated with the claims. Thedata suggest that claims associated with regional anaes-thesia are proportionately more likely in England thanNorth America. Non-obstetric claims appear to be of greater severity and are associated with higher cost thanobstetric claims. Factors frequently associated with litiga-tion include epidurals, nerve injury, inadequate anaes-thesia, obstetrics and, to a lesser extent, ophthalmicblocks. However, the data analysed have considerablelimitations and the potential lessons that might be learntfrom a genuine closed claims analysis are not achievablefrom these data. Introduction of a UK-wide closed claimsanalysis system would overcome many of the limitationsof the NHSLA dataset, and would be benecial to theNHS, anaesthetists and patients.

Acknowledgement

We are grateful to Ms Ruth Symons of the NationalHealth Service Litigation Authority for assistance with thedataset.

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Appendix 1

National Patient Safety Agency severity of outcome scale,for patient safety incidents.

Severity grade Description

None No harm (whether lack of harm was due toprevention or not)

Low Minimal harm necessi tat ing extra observationor minor treatment*

Moderate Signicant, but not permanent harm, or mod-erate increase in treatment

Severe Permanent harm due to the incident Death Death due to the incident

*First aid, additional therapy or additional medication.Excludes extra stay in hospital, return to surgery or readmission.Return to surgery, unplanned re-admission, prolongedepisode of care as in or out patient or transfer to another area such as intensive care unit.Permanent lessening of bodily functions, sensory,motor, physiologic or intellectual.

Appendix 2

Types of damaging events in the regional anaesthesiaclaims.

Allergy Infection (other)

Awareness Injury related to failure of block*Back pain Injury related to motor blockBladder damage Injury related to sensory blockCardiac arrest Iv injectionChild injury MeningitisConsent Nerve damageDrug error PainDural tap Pain during CSEpidural abscess Pain with EFLEpidural haematoma Pain intra-operat iveForeign body PneumothoraxGlobe perforation PsychologicalHeadache Spinal abscessHigh block with EFL Spinal cord ischaemiaHypotension Total spinalInappropriate block Wrong site of blockIndeterminate

*Injury related to general anaesthesia following failedregional anaesthesia.CS, caesarean section; EFL, epidural for labour.



litigios en anestesia regional

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