Can Epidurals Cause Long Term Problems
BMJ. 2002 Aug 17; 325(7360): 357.
Randomised study of long term upshot afterward epidural versus not-epidural analgesia during labour
Charlotte J Howell
a Academic Department of Obstetrics and Gynaecology, North Staffordshire Hospital (NHS) Trust, Stoke on Trent, Staffordshire ST4 6QG, b Physiotherapy Department, Staffordshire Rheumatology Middle, Haywood Hospital, Burslem, Stoke on Trent, c Section of Physiotherapy Studies and Primary Care Sciences Research Heart, Keele University, Keele, Staffordshire, d Department of Mathematics, Keele Academy, Keele, Staffordshire ST5 5BG
Tracy Dean
a Bookish Department of Obstetrics and Gynaecology, North Staffordshire Hospital (NHS) Trust, Stoke on Trent, Staffordshire ST4 6QG, b Physiotherapy Department, Staffordshire Rheumatology Centre, Haywood Hospital, Burslem, Stoke on Trent, c Department of Physiotherapy Studies and Primary Intendance Sciences Research Centre, Keele University, Keele, Staffordshire, d Section of Mathematics, Keele University, Keele, Staffordshire ST5 5BG
Linda Lucking
a Academic Department of Obstetrics and Gynaecology, North Staffordshire Hospital (NHS) Trust, Stoke on Trent, Staffordshire ST4 6QG, b Physiotherapy Department, Staffordshire Rheumatology Centre, Haywood Hospital, Burslem, Stoke on Trent, c Department of Physiotherapy Studies and Chief Intendance Sciences Research Center, Keele University, Keele, Staffordshire, d Department of Mathematics, Keele University, Keele, Staffordshire ST5 5BG
Krysia Dziedzic
a Bookish Department of Obstetrics and Gynaecology, North Staffordshire Hospital (NHS) Trust, Stoke on Trent, Staffordshire ST4 6QG, b Physiotherapy Department, Staffordshire Rheumatology Eye, Haywood Infirmary, Burslem, Stoke on Trent, c Section of Physiotherapy Studies and Primary Intendance Sciences Research Centre, Keele University, Keele, Staffordshire, d Department of Mathematics, Keele University, Keele, Staffordshire ST5 5BG
Peter West Jones
a Academic Department of Obstetrics and Gynaecology, North Staffordshire Infirmary (NHS) Trust, Stoke on Trent, Staffordshire ST4 6QG, b Physiotherapy Section, Staffordshire Rheumatology Center, Haywood Infirmary, Burslem, Stoke on Trent, c Department of Physiotherapy Studies and Primary Care Sciences Research Centre, Keele University, Keele, Staffordshire, d Section of Mathematics, Keele University, Keele, Staffordshire ST5 5BG
Richard B Johanson
a Academic Department of Obstetrics and Gynaecology, North Staffordshire Hospital (NHS) Trust, Stoke on Trent, Staffordshire ST4 6QG, b Physiotherapy Section, Staffordshire Rheumatology Centre, Haywood Hospital, Burslem, Stoke on Trent, c Department of Physiotherapy Studies and Primary Intendance Sciences Research Centre, Keele Academy, Keele, Staffordshire, d Section of Mathematics, Keele Academy, Keele, Staffordshire ST5 5BG
Abstract
Objective
To determine whether epidural analgesia during labour is associated with long term backache.
Blueprint
Follow up after randomised controlled trial. Assay by intention to treat.
Setting
Department of obstetrics and gynaecology at i NHS trust.
Participants
369 women: 184 randomised to epidural group (handling every bit allocated received by 123) and 185 randomised to non-epidural group (treatment as allocated received past 133). In the follow up study 151 women were from the epidural group and 155 from the non-epidural group.
Main outcome measures
Self reported depression back pain, disability, and limitation of motion assessed through one to one interviews with physiotherapist, questionnaire on back pain and disability, physical measurements of spinal mobility.
Results
At that place were no significant differences between groups in demographic details or other fundamental characteristics. The hateful time interval from commitment to interview was 26 months. At that place were no pregnant differences in the onset or elapsing of low back pain, with almost a tertiary of women in each group reporting pain in the calendar week before interview. There were no differences in self reported measures of disability in activities of daily living and no pregnant differences in measurements of spinal mobility.
Conclusions
After childbirth there are no differences in the incidence of long term low back hurting, disability, or movement brake between women who receive epidural pain relief and women who receive other forms of hurting relief.
Introduction
Epidural analgesia in labour is used by about 100 000 women in Britain each year.i All the same, not much is known on long term effects of this form of pain relief, and before this study anecdotal or case serial had concentrated on more than severe side furnishings, such as extremely rare neurological complications.2
In that location have been several studies into back pain and epidural analgesia (tabular array ane). MacArthur et al first suggested that epidural analgesia might be associated with low back in 1990.3 They carried out a postal questionnaire survey of 12 000 women who had delivered in Birmingham between 12 months and 9 years before. They found an unexpected clan between the use of epidural hurting relief for labour and long term low back pain (lasting more than three months). They were unable to make any assessment of the severity or aetiology of the low back hurting. The authors were aware that this association might not be causal, and they attempted to control for possible confounding factors by statistical aligning. Despite these adjustments, the clan between epidural pain relief for labour and the reporting of long term low back pain remained.
Table 1
Study | Design* | No of participants | Result for backache (epidural v no epidural) | Authors' conclusion |
---|---|---|---|---|
MacArthur, 1990iii | Retrospective postal questionnaire | 11701 | 18.ix% v 10.5% at 6 weeks | Relation between backache and epidural analgesia is probably causal |
Russell, 19934 | Retrospective questionnaire plus outpatient consultation | 1015 | 17.8% v 11.7% at 6 months | Though new long term backache is reported more than commonly after epidural analgesia in labour it tends to exist postural and not severe |
MacArthur, 19935 | Data extraction from 1990 survey paper and re-examination | 1141 | 18.half dozen% 5 9.2% at 6 months | Association with backache is real |
Breen, 199416 | Prospective interview and follow up past postal questionnaire | 1042 | 44% five 45% at 1-2 months | Epidural analgesia for labour and delivery did not seem to be associated with dorsum pain 1-2 months postpartum |
Macarthur, 199517 | Prospective cohort study with follow up | 329 | 14% v vii% at 6 weeks (relative run a risk 2.22, 95% CI 0.89 to 5.53) | Women who underwent epidural analgesia during delivery had increased incidence of low back pain but on first day afterwards delivery |
MacLeod, 19956 | Retrospective postal questionnaire | 2065 | 26.2% v 1.7% at ane twelvemonth | Association between backache and epidural may be causal just bias may be present. Controlled randomised study warranted |
Macarthur, 199715 | Retrospective telephone questionnaire | 329 | 10% (chose epidural) 5 14% (chose not to have) at 1 year | No increased take a chance of back pain in women who had used epidural analgesia |
In a farther retrospective observational study Russell et al constitute that 18% of women who received epidural analgesia had long term low back pain compared with 12% of those who used other forms of pain relief.4 Although there were suggestions that the excess low back hurting might stem from a "popular notion that epidurals cause long term backache," MacArthur et al maintained that the association was existent.5 Two years afterwards, MacLeod et al, in another retrospective study, reported an even greater difference, with 26% of women who had epidurals for analgesia complaining of depression back pain compared with only 2% in the non-epidural group.6
Given the bang-up human, medical, and economic costs of chronic low back pain7 we considered that a prospective controlled study with objective assessment of long term outcome was urgently needed. We had already undertaken a randomised controlled trial of epidural and non-epidural analgesia in labour, in which we examined the firsthand effects of the different forms of analgesia on progress of labour, satisfaction, and health after childbirth.viii Nosotros used the aforementioned general wellness questionnaire every bit MacArthur et al,three which incorporated questions on low back pain. However, this did not allow an objective cess of whatever back pain in terms of severity or the interference with mobility and activities of daily living.
We investigated long term differences in cocky reported and objective measures of low back pain between women who received epidural pain relief and those who received other forms of pain relief during labour.
Methods
Participants
For the original pain relief written report we had recruited 369 primigravidas with a cephalic presentation at term. All these women were invited to participate in this follow up report (151 from the epidural group and 155 from the non-epidural grouping agreed to participate). In the original study 184 women were randomised to receive an epidural and 123 received it, and 185 were randomised to other methods of pain relief but 52 had an epidural (see figure). The study had local ethics committee approval, and all women had given signed informed consent to participate.
Procedures
Assessment of depression back pain is complex as information technology involves the patient'due south personal and subjective feel of pain and disability equally well as objective assessment of physical impairment.7 We used the Roland and Morris questionnaire, which has been validated for assessing disability in activities of daily living due to low back hurting.9
Nosotros chose objective physical measurements that had previously been shown to identify those patients with low dorsum pain and that were significantly associated with self reported disability in activities of daily living.10 The range of movements included straight leg raising, spinal flexion and extension, lateral flexion, and ability to sit up. Additional measurements included the modified Schober distance and the fingertip to floor method of assessing frontward bending.vii ,eleven ,12 Before the study started we standardised assessment and carried out training to reduce intraobserver variability. TD undertook all assessments and was blinded to both the original group allocation and the method of pain relief actually received. Inevitably some women revealed this data during the class of the interview, and this was recorded.
The study ran from September 1995 to December 1997 (recruitment to the original pain relief study ended in September 1996). We contacted women who had taken part in the pain relief report and had given birth over 12 months previously. In previous studies researchers have plant it difficult to get women to come up to hospital for follow up assessments4 and then we commonly interviewed women in their own homes merely appointments could exist arranged at the hospital if this was more convenient. When a woman did not desire to participate in a face to face interview nosotros used a phone interview or a postal questionnaire.
Ability calculations and analysis
With 150 women in each group nosotros calculated that we could be lxxx% confident of detecting (at P=0.05) a clinically significant x% difference in objective measurements of low back pain at ii years.3
We analysed information on an intention to treat basis. Continuous data are expressed as hateful (SD), and we assessed differences with t tests. Frequency data were analysed with the StatXact Turbo parcel (CYTEL, Cambridge, MA, U.s.).
Results
Table 2 shows basic data for the two groups. These data reflect the validity of the original randomisation. The mean fourth dimension since delivery of the index pregnancy was over 2 years in both groups.
Table ii
| Epidural (north=151) | Non-epidural (n=155) |
---|---|---|
Maternal age (years) | 24.iv (five.1) | 23.5 (iv.7) |
No (%) with subsequent pregnancy | 36 (24) | 35 (23) |
Time since delivery of index pregnancy (months) | 26.6 (12.5, range 11-62) | 25.9 (12.1, range 12-62) |
Gestation at delivery (weeks) | 40 (1.half dozen) | 40 (1.five) |
Birth weight (1000) | 3440 (385) | 3429 (490.9) |
No (%) with spontaneous labour | 125 (83) | 122 (79) |
The figure shows the entry catamenia for the study. The proportion of women who received their allocated method of pain relief in the original study was similar in both groups, every bit were the proportions past method of follow up and the proportions in which the assessor remained blind to the original method of analgesia (epidural 126/151 v non-epidural 138/155).
The incidence of cocky reported depression dorsum pain during or later pregnancy was high (table three). There were no significant differences in terms of the timing of onset. Back hurting was mutual in both groups and more women reported severe pain in the epidural group, but hurting lasting more than i year, persistent pain, and recent pain were all more common among women who had not had an epidural.
Tabular array 3
| Epidural (northward=151) | Non-epidural (n=155) |
---|---|---|
Experienced dorsum pain | 115 | 112 |
Pain began during pregnancy | 87 | 83 |
Pain began after commitment (fourth dimension): | ||
Shortly after | fourteen | 12 |
i-2 months | ii | 1 |
2-4 months | 4 | 2 |
6-12 months | 0 | one |
12-18 months | 0 | i |
eighteen-24 months | 0 | ane |
>ii years | 1 | 0 |
Another fourth dimension | 7 | 11 |
Hurting lasted >1 year | 47 | 64 |
Still experiencing hurting now | 64 | 70 |
Pain in past week | 46 | 47 |
Terminal episode of pain: | ||
Very bad/unbearable | 17 | 13 |
Moderate/quite bad | 67 | 67 |
Piffling pain | 30 | 25 |
No respond | 1 | seven |
Most common site of pain: | ||
Lumbar/upper sacral region | 90 | 76 |
Multiple areas | 19 | xx |
Other areas | 4 | 11 |
Site not specified | 2 | v |
Pain alters during menstruation | 26 | 25 |
Nosotros measured a range of movements in 117 of 119 women in the epidural group who were interviewed and 117 of 122 in the non-epidural group (table 4). The vii women who were not examined at all were significant at the time of the cess, and measurements were omitted at the request of the woman or on the advice of the research physiotherapist. There were no significant differences betwixt the groups in any of the measurements of mobility. In that location were besides no differences in responses to questions about everyday tasks that may be more hard in the presence of low back pain (table 5).
Tabular array 4
| Epidural (north=119) | Non-epidural (n=122) | 95% CI for deviation in means or % |
---|---|---|---|
Modified Schober altitude (cm) | 6.ix (i.three), north=115 | 6.8 (i.3), n=116 | −0.237 to 0.437 |
Fingertip to floor distance (cm) | ane.8 (5.6), northward=117 | two.1 (5.viii), n=117 | −1.77 to 1.17 |
Right lateral flexion (cm) | 22.1 (4.seven), north=116 | 22.6 (4.4), due north=117 | −1.68 to 0.675 |
Left lateral flexion (cm) | 22.3 (4.six), n=116 | 22.ix (iv.5), northward=117 | −i.77 to 0.575 |
Total spinal flexion—decumbent (cm) | 9.7 (2.v), n=117 | 10 (two.iv), northward=113 | −0.937 to 0.337 |
Total spinal extension—prone (cm) | 4.1 (2.1), northward=117 | 3.8 (two.2), n=104 | −0.27 to 0.87 |
Directly right leg raised—supine (cm) | 86 (11.v), n=117 | 87.7 (9.7), north=116 | −4.45 to i.05 |
Direct left leg raised—supine (cm) | 86.3 (12.1), n=116 | 88.iii (9.4), north=116 | −4.viii to 0.803 |
No (%) able to sit down up with knees flexed, hip/knee flex/ext | 60 (52%), n=115 | 52 (47%), north=110 | −8.2% to eighteen% |
No (%) able to concur position for v seconds | 108 (94%), north=115 | 103 (93%), northward=111 | −5.four% to 7.vi% |
Tabular array 5
| Epidural (due north=151) | Non-epidural (due north=155) |
---|---|---|
I stay at home | 3 | 1 |
I modify position oftentimes | 35 | 38 |
I walk more than slowly than usual | viii | 10 |
I avoid jobs effectually the firm | 4 | 2 |
I apply handrail to get upstairs | two | half dozen |
I lie down and residuum more ofttimes | 9 | 12 |
I hold on to something when getting up from a chair | five | viii |
I go other people to do things for me | half-dozen | 5 |
I get dressed more slowly than usual | 6 | 4 |
I represent only brusk periods of time | nine | 18 |
I try not to bend downwardly or kneel | twenty | 16 |
I find it hard to go out of a chair | 11 | 3 |
My back is painful about of the time | half dozen | 9 |
Information technology is difficult to plough over in bed | 21 | 13 |
My appetite is not good | 2 | 0 |
I have trouble putting socks on | 8 | half-dozen |
I only walk for curt distances | 2 | viii |
I sleep less well | 21 | 21 |
I go dressed with assistance from someone else | 1 | 0 |
I sit down for nigh of the day | 3 | 2 |
I avoid heavy jobs around the house | 15 | 19 |
I am irritable and bad tempered | ten | 14 |
I go upstairs more slowly | 4 | 11 |
I stay in bed for most of the fourth dimension | two | 1 |
Discussion
In this controlled comparing of the long term furnishings of epidural and non-epidural analgesia we found no significant differences in cocky reported depression dorsum pain or disability and in objective measurements of spinal mobility after more than two years. The validity of these findings is affirmed by the randomised study design, the objective measures of outcome, and the loftier follow upwardly rate.
Limitations
The interpretation of our findings is limited by the number of crossovers between groups. This is inevitable in trials that compare epidural and not-epidural pain relief13 only was lower in our study than in others. This study could therefore exist considered as showing the differences betwixt liberal and restricted use of epidural analgesia in labour. The absolute difference in epidural use was 40%. Despite the real life crossover between groups we found a significant association between use of epidural analgesia and the rate of assisted delivery, being thirty% compared with 19% in the non-epidural group.8 If an increased incidence of low back pain was also attributable to the use of epidurals, it too could accept been shown despite the crossover. Our analysis was on an intention to treat basis for valid scientific reasons14 and also considering this is the standpoint from which women volition arroyo labour. They may be intending to employ item forms of analgesia, but in the real world some women may find non-epidural methods insufficient or may exist managing so well that they practise non utilise the epidural that they planned. The findings are also limited by the moderate numbers of women included, significant that rare events of harm could not take been reliably detected.
Previous studies
MacArthur and coworkers reviewed half dozen comparative studies which examined the association between epidural analgesia and postpartum low dorsum pain.xv The three studies that showed a pregnant consequence were all retrospective, while the prospective surveys showed no significant differences.16 ,17 This important deviation in findings illustrates the potential for bias in retrospective studies and similarly supports the value of advisedly designed prospective studies, fifty-fifty if it is not feasible to generate a randomised cohort of patients.
Back pain in pregnancy
We institute that reported rates of depression back pain were loftier during pregnancy and at long term follow upwardly in both groups of women. The proportions were similar to those observed past Ostgaard and Andersson in their prospective written report of 817 women during pregnancy who were followed upwards for 12 months or more afterwards delivery.18 They found that more than 67% of women experienced low back pain straight after delivery and 37% at the later follow upwardly test. Factors associated with persistent hurting were the presence of low dorsum pain before or during pregnancy, physically heavy piece of work, and multiple pregnancy. This effigy is somewhat higher than the overall prevalence of low back pain in women in adult countries.xv It is likewise significantly college than the prevalence constitute in men, which supports the view that pregnancy may influence the development (or course) of depression back hurting.18 – 20
Farther enquiry
Although our study was powered to detect an absolute difference of x% in the incidence of back pain, the findings of almost equal numbers in each group with most outcomes measured means that future controlled comparisons would require many thousands of participants. Given our findings, further research into complications of epidural analgesia will need to be based on large national cohorts of patients to place risks for rare bug.
Acknowledgments
This paper is defended to Richard Johanson, who died a few months before publication. Dr One thousand Waddell gave advice on methodology. Nosotros are grateful to all the women who participated.
Footnotes
Funding: National Back Pain Association. RJ, KD, and LL's clinical trials activities are supported by grants from the NHS(E) West Midlands research and development programme.
Competing interests: None declared.
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Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC117883/
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