1Department of Anaesthesiology and Intensive Care and 2Department of Obstetrics and Gynaecology, Herlev University Hospital, Copenhagen County, Denmark*Corresponding author
LMA is the property of Intavent Limited.
Accepted for publication: April 10, 2001
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Abstract |
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Br J Anaesth 2001; 87: 57783
Keywords: anaesthetic techniques, general; anaesthetic techniques, epidural; anaesthetics local, lidocaine; anaesthetics local, bupivacaine; pain, postoperative; surgery, gynaecological
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Introduction |
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Epidural local anaesthetics (LA) results in effective pain relief11 and improved GI motility compared with opioid-based analgesia after hysterectomy.8 7 12 However, relative importance of spinal reflex activity induced by surgery/postoperative pain, and perioperative opioid administration, for the reduction in GI motility, is not settled.13 Hence, the beneficial effect of epidural LA on postoperative GI function may be a result of neural block during and/or after surgery reduced opioid consumption, or both.
Paracetamol and NSAIDs have been shown to reduce pain and the need for opioids after hysterectomy.14 15 In a recent study, combined paracetamol, NSAID, and continuous 24 h infusion of epidural LA provided effective postoperative pain relief after hysterectomy. Median time to first passage of flatus and faeces was less than 48 h. It was not clear from this study, however, whether the relatively short duration of GI paralysis was because of administration of intra- and postoperative epidural LA, an opioid-sparing effect of paracetamol and NSAID, or both.11
The aim of this study was to compare the effect of combined general anaesthesia and postoperative paracetamol and NSAID, with or without intraoperative, or intra- and 24 h postoperative epidural LA, on pain and GI function after abdominal hysterectomy.
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Patients and methods |
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Preoperatively, patients were randomized by a computer program to general anaesthesia (the GA group), or combined general and epidural anaesthesia, using sealed envelopes. For patients randomized to combined general and epidural anaesthesia, a number referring to the postoperative epidural study drug, was stated in the envelope.
One hour before surgery patients had sublingual triazolam 0.125 mg.
Patients randomized to GA were induced with propofol 1.52.5 mg kg1, alfentanil 1.0 mg, fentanyl 0.3 mg, and rocuronium 0.6 mg kg1, and a tracheal tube was inserted. Propofol was given without nitrous oxide for maintenance of anaesthesia. If arterial pressure and/or heart rate increased to greater than 120% of initial values, fentanyl 0.1 mg was administered.
Patients randomized to epidural treatment, had an 18-gauge epidural catheter inserted through a Touhy needle and advanced 45 cm into the epidural space at the T1011 level, and a 4 ml test dose of 2% lidocaine with ephinephrine was administered. A bolus dose of 16 ml of 2% lidocaine with epinephrine was administered, followed by continuous infusion of 8 ml h1 of 2% lidocaine throughout the operation. General anaesthesia was induced with propofol 1.52.5 mg kg1 and alfentanil 1.0 mg, and a laryngeal mask airway (LMA) was inserted. Propofol without nitrous oxide was given for maintenance of anaesthesia. No additional doses of lidocaine or alfentanil were given.
For all patients, hypotension was treated with i.v. infusion of isotonic sodium chloride, HAES 6% or ephedrine 5 mg i.v. in incremental doses, when systolic arterial pressure was below 90 mm Hg. Fluid and blood losses were replaced according to the prescriptions of the department.
At skin closure, patients in the epidural group received bupivacaine 0.2% (the Bupi group) or saline (the Saline group) as a bolus of 8 ml and continuous infusion of 8 ml h1 for 24 h. The study drugs were prepared by the hospital pharmacy in identical containers, marked with a number, the name of the project and the investigators name. This part of the study was double blinded.
For the first 48 h after surgery, all patients received 2 G paracetamol rectally every 8 h, thereafter 1 G orally every 6 h. For the first 72 h, all patients received ketorolac 30 mg i.m. every 8 h. If additional analgesic was required, morphine 0.125 mg kg1 was given.
Patients were given ondansetron 4 mg i.v., if they demanded antiemetics. If an additional antiemetic was required before another dose of ondansetron could be administered (8 h), metoclopramide 10 mg i.v. was given.
All patients were instructed preoperatively on the use of the visual analogue scale (VAS) pain score, and to request supplementary analgesic and antiemetics if needed.
Pain scores were assessed by the patients at 4, 6, 22, 24, 26, 30, 48, and 72 h after the operation on a VAS (0 mm=no pain, 100=worst pain imaginable) at rest, on coughing, and on mobilization from the supine to the sitting position. The number of morphine doses was recorded at the same times. Levels of sensory block to pinprick were assessed bilaterally at 6, 24, 26, and 30 h after operation; in the event of asymmetrical block the most extensive spread was recorded. Motor block was assessed using a four-point modified Bromage scale (0=no motor block, 1=inability to raise extended legs, 2=inability to flex knees, 3=inability to flex ankle joints) at 6, 22, 24, 26, and 30 h after operation. Ability to walk on the floor (0=no difficulty, 1=little difficulty, 2=very difficult, 3=impossible, 4=difficult or impossible for other reasons than motor block) was assessed at 6, 22, 24, 26, 30, and 48 h after operation. The actual duration of mobilization (<1, 14, or >4 h) during the 2448 and 4872 h intervals was assessed at 48 and 72 h after the operation. Patients who were not able to mobilize at >4 h were asked for the primary reason for this. At all visits, gastrointestinal function was monitored by asking the patients if and when they had first passage of flatus and faeces, and if they had experienced nausea (0=no, 1=light, 2=moderate, 3=severe) and/or vomiting since last assessment.
Patients were encouraged to eat and drink whenever possible after the operation. Ingestion of predefined quantities of food and beverages was assessed at 24, 48, and 72 h after the operation.
Every 24 h after the operation, patients were assessed as ready or not ready for discharge from hospital, by four discharge criteria: (1) Normal defecation and no urinary retention: yes/no; (2) able to mobilize and dress: yes/no; (3) need for opioid: yes/no; (4) surgical complication requiring patient hospitalized: yes/no. When the patient scored yes on the two former, and no on the two latter questions, they were assessed ready for discharge from hospital.
The primary end-points of this study were pain during coughing, and time to first passage of faeces. Power calculation for the pain score was based on results from an unpublished pilot study performed at our institution (VAS pain scores during cough, in the general anaesthesia group, 24 h after the operation: 40 mm; type 1 error: 5%; type 2 error: 20%; minimal difference not to be overlooked: 20 mm reduced pain score; sample size needed: 16 patients in each group). Power calculation for time to first postoperative defecation was also based on the results from the unpublished pilot study in hysterectomy patients. (On day 3 after the operation, 17% have defaecated. Other type 1 error: 5%; type 2 error: 20%; minimal difference not to be overlooked: 50% reduction in time to first postoperative defecation: sample size needed 14 patients in each study group.) Data are presented as medians with upper and lower quartiles. Statistical analyses were performed using the MannWhitney rank sum test for unpaired data, Wilcoxon signed rank sum test for paired data, and Fishers exact test for dichotomous data, where appropriate. If multiple testing was performed, significant P values were corrected with a Bonferroni factor for multiple comparisons.
In addition, a longitudinal analysis of VAS pain scores was performed. In order to make the normality assumption more reasonable, we performed a square root transformation of the VAS scores before analysis. The model allowed for correlation between measurements on the same patient, in the form of a random level and an autoregressive error over time. Apart from time itself (regarded as a categorical variable to allow for maximal flexibility) and treatment group, we considered the covariates duration of operation, age of patient and Phannenstiel or median inferior incision. The analyses were made for three different VAS pain scores: at rest, during cough and during mobilization, and each 24 h interval was treated separately. A Cox regression analysis with time to first postoperative faeces and flatus as dependent variables was performed. Covariates chosen beforehand were: treatment group, duration of operation, milligram of morphine before the event and age. P<0.05 was considered statistically significant. Calculations were performed using SPSS 9.0 for Windows and SAS 6.12 (PROC MIXED procedure).
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Results |
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There were no significant differences between groups for patient characteristics or operative data, except for peroperative fentanyl and ephedrine (Table 1). Eleven and 10 patients in groups 2 and 3, respectively, needed i.v. ephedrine.
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There were no significant differences in motor block, assessed by the modified Bromage scale, at any assessment. At 24 h after the operation, 70% in the GA group compared with 65% in the Saline group and 45% in the Bupi group were able to walk on the floor without difficulty (P>0.05); at 30 h the corresponding numbers were 75, 80, and 85% (P>0.05) (Fig. 2). At 24 h after the operation, the ability to walk could not be evaluated for different reasons. In the GA group, patients stated dizziness (15%) and nausea (15%) as primary reasons, in the Saline group pain (20%) and nausea (10%), and in the Bupi group motor block (20%) and dizziness (20%). There were no differences in the actual duration of mobilization (Fig. 3). The primary reasons for mobilizing <4 h were pain and fatigue both in the 2448 and 4872 h intervals.
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Most patients had an indwelling bladder catheter, which was removed on the morning after surgery. After removal, two patients, one from the Saline group and one from the Bupi group, complained of urinary retention, lasting a few hours.
Patients fulfilled discharge criteria at median 3 (quartiles 34), 4 (36), and 5 (37) days after operation in the GA-, Saline- and Bupi groups, respectively (ns).
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Discussion |
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The main problems of abdominal hysterectomy in the immediate perioperative period are pain, PONV, and gastrointestinal paralysis, which may postpone recovery and discharge from hospital. The optimal anaesthetic regimen for this procedure should carry a low risk, along with effective pain relief and minimal, if not protective, effects on the gastrointestinal dysfunction and PONV induced by surgery. Hence, anaesthetics and analgesics, which produce effective analgesia with a low potential for gastrointestinal side effects, should be advantageous.
This study was designed to investigate whether addition of intraoperative, or intraoperative plus 24 h postoperative epidural analgesia to an opioid-sparing regimen with paracetamol and NSAID, was able to further reduce pain, improve gastrointestinal function, and enhance recovery.
Results showed a significant reduction in pain and need for supplementary morphine during epidural treatment with bupivacaine. This effect was, however, not sustained beyond the time of the epidural infusion. Gastrointestinal function was only marginally improved, with a minor reduction in time to first postoperative flatus. Side effects, including PONV, were similar in the three study groups, as was recovery as measured by ability to ambulate, oral ingestion of food and fluid, and fulfilment of discharge criteria.
Intraoperative epidural analgesia per se had no influence on postoperative pain or gastrointestinal function compared with the GA group. Hence, no protective analgesic effect of neither a short lasting, nor a 24-h epidural regimen with LA was observed in this study.
Previous studies, in patients undergoing abdominal hysterectomy8 and colonic surgery,1618 have shown that an epidural regimen with LA reduces postoperative pain compared with regimens based on systemic opioids. The present study confirms these results. A longitudinal analysis of variance components, with pain score as the dependent variable, was performed in this study. The covariates, other than treatment group: duration of operation, age of patient, and type of incision were included in the analysis with a hypothesis generating purpose, but none of these showed significant influence on postoperative pain scores. However, it may be that the insignificant results could also be a result of the limited range of covariates and study size.
In contrast to a meta-analysis of previous studies,8 16 1921 showing a reduction in time of postoperative gastrointestinal paralysis of about 40 h,10 the effect of epidural LA on gastrointestinal function in the present study was only small. In contrast to previous studies (except for ref. 17), patients in the GA (control) group in our study received both paracetamol and NSAID, and this opioid-sparing regimen may have reduced gastrointestinal paralysis and thus blunted the effect of epidural anaesthesia. This suggestion, however, has to be confirmed in controlled studies.
No differences in the incidence of side effects was found in this study, but the relative small number of patients in each study group, does not allow firm conclusions.
To be able to evaluate effects of the different regimens on recovery itself, criteria concerning ambulation, oral ingestion of food and fluid, and discharge from hospital were standardized. It should be emphasized, though, that fulfilling discharge criteria did not necessarily mean that patients were actually discharged from hospital. Thus, patients in the GA-, the Saline-, and the Bupi group were actually discharged from hospital on the fourth, fifth, and fifth day, respectively. The most frequent reason for this discrepancy was either a different assessment by the surgeon, or social causes concerning the patient. Still, no differences were observed between groups, and improved analgesia during the first postoperative 24 h was not followed by faster recovery in the Bupi group.
In conclusion, a 24 h postoperative epidural infusion with bupivacaine, when added to postoperative paracetamol and NSAID, reduced pain and opioid requirements, but had no analgesic effects beyond the time of the epidural infusion, and only limited effects on gastrointestinal function and patient recovery after abdominal hysterectomy. Epidural anaesthesia may be superfluous in this surgical procedure.
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Acknowledgements |
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References |
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