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Department of Anesthesiology, Herlev University Hospital, Herlev, Denmark
Address correspondence to Steen Møiniche, MD, The Department of Anesthesiology, Herlev University Hospital, DK-2730 Herlev, Copenhagen, Denmark. Address e-mail to stmi{at}herlevhosp.kbhamt.dk
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Abstract |
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Implications: A systematic review summarizes, through transparent methodology, available information from randomized, controlled trials to produce the best available evidence-based estimate of a "true" clinical effect of an intervention. This systematic review confirms intraperitoneal and mesosalpinx local anesthetic block, not port-site infiltration, to have some impact on postoperative pain after laparoscopy.
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Introduction |
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Compared with open procedures, laparoscopic surgery, a minimally invasive technique, is associated with reduced surgical trauma (3,4) and accordingly, is often performed as day-case surgery. Peripheral use of local anesthetics after laparoscopic surgery may therefore, as in the case of minor open procedures, be more likely to provide clinically relevant postoperative pain relief in the early postoperative period. This has been the hypothesis of several trials published in the last decade. However, results from these trials are inconsistent and difficult to overview.
In recent years, several systematic reviews have been published in the field of pain. These reviews summarize available information from randomized controlled trials (RCTs) to produce the best available evidence-based estimate of the "true" clinical effect of an intervention.
The purpose of this systematic review is to evaluate the effect of peripherally applied local anesthetics - intraperitoneal instillation, trocar- and port-site wound infiltration, and visceral infiltration/application - on postoperative pain in patients undergoing laparoscopic surgery, by using evidence from all relevant double-blinded, randomized controlled trials.
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Methods |
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Reports were identified by using the Cochrane Library (1999) and the MEDLINE (1966–1999) databases without language restriction. We used different search strategies with free text combinations, including the search terms: "laparoscopy," "laparoscopic," "surgery," "cholecystectomy," "sterilization," "intraperitoneal," "wound infiltration," "incisional," "visceral," "postoperative pain," "local anesthesia," "bupivacaine," "lidocaine," and "ropivacaine." The last search was ultimo May 1999. Additional reports were identified from reference lists of retrieved reports and review articles. No abstracts, correspondences, or unpublished observations were included.
Reports included were double-blinded, randomized comparisons of intraperitoneal instillation, port-site wound infiltration, and visceral infiltration/application of local anesthetics with placebo (saline) and no treatment for postoperative pain treatment after laparoscopic surgery. Only reports considering adult patients (defined as age >15 yr) were included. Studies of open abdominal surgery and direct comparisons of local anesthetic treatment with other treatment modalities as an active control, were not considered.
Each report, meeting the inclusion criteria were read independently by each of the authors and scored by using a three-item, 1–5 quality scale (5). Consensus was subsequently achieved. When the reports were described as randomized, one point was given. An additional point given when the method of randomization was described and adequate (computer generated, table of random numbers, etc.). However, one point was deducted when randomization was inappropriate (alternate randomization, randomization according to weekday, etc.). When studies were described as double-blinded, one point was given, and an additional point given when blinding was described and appropriate (blinded pharmacy manufactured ampules, etc.). However, one point was deducted when blinding was inappropriate. Finally, reports which described the numbers and reasons for withdrawals were given one point. By definition, studies without randomization and blinding were excluded. Thus the minimum score of an included RCT was 2 and the maximum score was 5. Information about type of anesthesia (general, regional), number of patients enrolled, plasma-concentration of local anesthetics, and adverse effects was taken from each report.
The plot of L’Abbé et al. (6) of visual analog scale (VAS) pain scores with local anesthetics compared with a control group was used as a graphic means of exploring the consistency of efficacy and the homogeneity of the data. A scatter of the individual trials lying predominantly to the right of the equality line would suggest efficacy with local anesthetics and relative homogeneity.
Quantitative analysis of combined data was proposed by calculation of the weighted mean difference of VAS early postoperatively between treatment groups, taking into account study size and standard deviations of the VAS scores in the individual trials by using the Review Manager software, version 3.11 (Cochrane Collaboration; The Nordic Cochrane Center, Copenhagen, Denmark). Studies using pain scores other than VAS (e.g., McGill or verbal rating scores) were not included in the quantitative analyses. When data allowed only a qualitative analysis, postoperative effectiveness was evaluated by significant difference (P < 0.05 as reported in the original investigation) in pain relief using pain scores (VAS or similar scores), time to first analgesic request, and consumption of supplementary analgesics compared with control. Local anesthetic dosages in positive and negative trials were compared with Mann-Whitney’s nonparametric test. Finally, sensitivity of evaluated nonsignificant studies (power of statistical tests) was considered. Any statistical power analysis of individual studies was noted.
We planned to stratify the trials according to the mode of local anesthetic administration (intraperitoneal instillation, trocar- and port-site wound infiltration, visceral application, or combinations), and when possible, to laparoscopic procedure (cholecystectomy, sterilization, etc).
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Results |
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We studied 2794 patients, 1510 of whom received four different local anesthetics (bupivacaine, lidocaine, etidocaine, ropivacaine). The range of number of patients included in the studies was 22–300. The median quality score was 3 (range 2–5). Details of included studies are shown in Tables 1–5. Authors of six papers (18–23) were contacted for provision of dispersion measures needed for the quantitative analyses; however, measures were only obtained in one case (19). Authors contacted regarding their References (24,25) confirmed that patients included in these trials were not identical and that one study (13) was not blinded.
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Intraperitoneal Local Anesthetics for Postoperative Pain Relief After Laparoscopic Cholecystectomy
We identified 13 trials with 18 treatment arms comparing bupivacaine 50–155 mg (in 17 treatment arms) or lidocaine 100 mg (in one treatment arm) with saline (20–22,24,25,28–35) or no treatment (30). In all trials the local anesthetic was administered in the right subdiaphragmatic or gall bladder region in concentrations between 0.1% and 0.5%, 10 and 100 mL at the beginning of the procedure (24,25,28), the end (20–22,25,30–35), or both (24,25,29) (Table 1). Overall, seven of the 13 trials found improved pain relief for at least one of the evaluated pain measures (20,21,24,25,28–30).
In seven trials with 10 treatment arms, overall pain scores, and pain scores for abdominal pain or shoulder-tip pain were significantly reduced compared with the control patients (20,21,24,25,28–30) (Table 1 and Figure 1, top). In most studies, pain scores were only reduced early postoperatively (2–8 h) (20,21,28–30); however, in two trials, reductions lasted up to 24 h (24,25). In the six other trials with eight treatment arms, no effect on pain scores and supplemental analgesic consumption was observed (22,31–35) (Table 1 and Figure 1, top).
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There was no obvious relationship between achieved pain relief, application site, and dose of local anesthetic. The mean dose of bupivacaine was 112 ± 54 mg (SD) in positive trials and 116 ± 35 mg in negative trials (P = 0.61). Pain intensity reports (of importance because it is difficult to detect an improvement in pain if absent or only mild) were not considered to render negative studies insensitive because VAS scores in the control group of most negative studies were >30 mm (22,32,34,35). Appropriate power analysis of the statistical tests was not performed in any of the negative trials.
Intraperitoneal Local Anesthetics for Postoperative Pain Relief After Other Laparoscopic Procedures
Four trials of a variety of procedures (diagnostic and operative gynecological laparoscopy, sterilization, fundoplication, appendectomy, hernia repair, cholecystectomy) evaluated intraperitoneal instillation of bupivacaine 50–100 mg (36–38) or lidocaine 400 mg (36,39) with saline (36–38) or no treatment (39). Table 2 provides more detailed information about the regimens.
All studies showed significantly reduced pain scores with VAS reductions up to 26 mm early, but also up to 24 h postoperatively (36–39). Furthermore, supplemental analgesic consumption was significantly reduced approximately 50% in three (36,38,39) of the studies. Time to first analgesic request was recorded in only one trial and did not differ between the treatment and control groups (37). Quantitative analysis was omitted because of the different procedures and application sites (subdiaphragmatic or pelvic) investigated.
Trocar and Port-Site Infiltration with Local Anesthetics for Postoperative Pain Relief After Laparoscopic Procedures
We identified eight studies with 11 treatment arms that compared bupivacaine with saline (19,39–44) or no treatment (39,45) (Table 3). Procedures included diagnostic and operative gynecological laparoscopy, cholecystectomy, and hernia repair. The local anesthetic was infiltrated subcutaneously (39,45), subfascially, or preperitoneally (40,41,43), or into all layers of the abdominal wall, including the cutaneous tissues, muscle, and parietal peritoneum (19,42,44). The concentrations used were between 0.125% and 0.5%, in volumes between 5 and 60 mL with a mean dose of 76 ± 48 mg. Infiltration of port sites was performed preoperatively in two (40,42) and postoperatively in nine treatment arms (19,39–41,43–45).
Overall, only three of the eight trials were positive for at least one of the evaluated pain measures (19,40,45). First, improved postoperative pain scores from incisional local anesthetics were observed in only one trial (19) (Figure 1, middle), although Ke et al. (40) and Bilge et al. (45) found a significant difference at the 24 h, not at the one-half, 1, 2, 4, 6, or 12 h assessments (40,45), questioning the validity of these results. Quantitative analysis of five studies using a fixed effect model (P = 0.3 in test for heterogeneity) revealed that the weighted mean difference in VAS scores between treatment groups was not significant (-4 mm, 95% CI -9 to 1, Figure 2, middle). Of the three studies not included in the quantitative analysis because of use of McGill pain scores (39,40,43), one study was partly positive (40), and two were negative (39,43). Second, time to first analgesic request was only evaluated in one study with two treatment arms, showing a significant prolongation of between 4 and 6 h compared with saline (40). Third, in one trial, consumption of supplementary analgesics was significantly reduced 24% in the treatment group compared with control (45). In the seven other trials no effect on supplemental analgesic consumption was observed (19,39–44) (Table 3).
No obvious relationship was apparent between application site, dose of the local anesthetic, and degree of obtained pain relief. Mean dose of bupivacaine was 50 ± 0 mg in positive trials and 91 ± 56 mg in negative trials (P = 0.77). Low pain scores were not considered to render negative studies insensitive because VAS was >30 mm (or at least moderate according to the McGill scale) in the control groups of most of the negative trials. Power analysis was, however, only performed in two studies (40,42) revealing a 80% power to detect a difference of 15 mm VAS and 1.7 on the McGill scale at the 5% significance level.
Mesosalpinx/fallopian Tube Block with Local Anesthetics for Postoperative Pain Relief After Laparoscopic Sterilization
A total of 12 trials with 14 treatment arms were identified comparing bupivacaine (18,46–50), lidocaine (46,51–54), or etidocaine (23,55) with placebo (18,46,49,50,53–55) or no treatment (23,46–48,51,52). The local anesthetic was infiltrated into mesosalpinx (18,46,48,51,54), dripped on the fallopian tubes (23,47,49,50,55), or coated on Filshie clips (52,53). Details about doses (concentration and volumes) can be obtained from Table 4. In all trials, improved postoperative pain relief was obtained in the immediate postoperative period, with significantly reduced pain scores in 13 of 14 treatment arms (Figure 1, bottom) (18,23,46–55), 50% to 70% reduced analgesic consumption in eight of 12 treatment arms evaluating this measure (18,23,46–48,53,54), and prolonged time to first analgesic request in the three studies evaluating this (49,53,54).
Quantitative analysis was only possible with seven of the 12 trials because of the use of McGill or verbal rating pain score (47,50,51), or lack of dispersion measures (18,23). The analysis, performed by using a random effect model (P < 0.0001), revealed a significantly reduced weighted mean difference of -19 mm on the VAS scale (CI -25 to -14) in favor of treatment supporting the qualitative estimate (Figure 2, bottom). It should be emphasized, however, that pain relief in general was very short-lived, in most studies lasting for 1–2 h postoperatively.
Regimens with Combined Application Sites of Local Anesthetics for Postoperative Pain Relief After Laparoscopic Procedures
In four trials, various combinations of local anesthetic use was evaluated (Table 5). Cook and Lambert (56) evaluated port-site infiltration plus tubal application of bupivacaine compared with no treatment and found no effect on pain outcome measures (56). On the other hand, three studies comparing port-site infiltration plus intraperitoneal instillation of bupivacaine (57), mesosalpinx infiltration plus intraperitoneal instillation of lidocaine (58), or port-site infiltration plus mesosalpinx infiltration and intraperitoneal instillation of ropivacaine with placebo (59) found significantly reduced pain scores and analgesic consumption up to 4 h postoperatively (57,59) or >24 h after surgery (58). In the study by Callesen et al. (59), extensive use of the rather large doses of ropivacaine (285 mg) virtually abolished postoperative pain, only in the immediate postoperative period and not beyond the expected duration of the local anesthetic. Because of the very different regimens, quantitative analysis was not performed.
Side Effects and Plasma-Concentration of the Local Anesthetic
No side effects or signs of toxicity attributable to the local anesthetic were reported. However, such information was only provided in 12 trials (six trials of intraperitoneal local anesthetic, one of port-site infiltration, three of laparoscopic sterilization and two with combined use of local anesthetics) (25,29–31,33,38,42,46,51,52,58,59). Plasma concentration of local anesthetics was measured in only six studies (31–33,35,39,58). In all cases, plasma concentrations were well below a presumed toxic plasma level of 2–4 µg/mL for bupivacaine and 5 µg/mL for lidocaine (60) except for the study by Fuhrer et al. (35), in which one patient had a maximum plasma bupivacaine concentration of 2.23 µg/mL. Peak plasma concentration was measured between 15 and 30 min after the administration (31–33,35,39) except for one study of combined intraperitoneal and mesosalpinx infiltration in which time to peak plasma concentration was approximately 40 min (58).
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Discussion |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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We sought to evaluate the effect of peripheral local anesthetics for postoperative pain relief after laparoscopic surgery compared with placebo or no treatment, given the strict inclusion and exclusion criteria described above. The trials were divided into trials of intraperitoneal instillation, port-site infiltration, mesosalpinx/fallopian tube block, or combined regimens to reduce confounding factors and make comparisons possible.
We chose, in addition to the qualitative systematic review, to include a statistical combination of data from the independent results in a quantitative analysis. This was done to produce a single estimate of the effect of the intervention, and to help resolve disparities between conflicting studies (64). However, some trials were not included in the quantitative analyses because of lack of data necessary for the calculation, and this may make the results of the quantitative analyses somewhat tenuous. Therefore, the qualitative and quantitative analyses should be viewed together whenever possible, to achieve an overall synthesis of the results from the original trials.
General Comments on Pain
Even within the same type of procedure, pain after laparoscopic surgery may vary in quality and localization and is reported in several trials to be incisional, intraabdominal, or referred (shoulder tip) (65). The etiology is complex, including damage to abdominal wall structures, the induction of visceral trauma and inflammation (34,61,65), and peritoneal irritation because of CO2 entrapment beneath the hemidiaphragms (66,67). In several trials, attempts have been made to differentiate between the various pain qualities and localizations (21,28,30,31,33,34,36,43); however, the results and conclusions are difficult to interpret, with several authors also expressing difficulties in making this differentiation (43,54). Accordingly, most trials only reported on overall postoperative pain. Furthermore, the literature varies in the reporting of the localization of the most severe pain. Some authors report intraabdominal pain as the most pronounced (20,28,34), although others state incisional (21,42,68) or shoulder-tip pain (36) is the most painful. Ultimately, this may depend on the time course and conditions under which pain is assessed (at rest or during motion). Thus, it was impossible to differentiate regarding pain localization in the quantitative analysis and instead, the reporting of pain in the individual trials was documented in table format.
Intraperitoneal Local Anesthetics
Results from reports of intraperitoneal local anesthetics after laparoscopic surgery revealed weak evidence for an effect on postoperative pain. Especially after laparoscopic cholecystectomy, the evidence was not compelling, and the clinical significance, at least regarding pain scores, was questionable. The differences between results in the various RCTs are difficult to explain. Although applied doses of local anesthetics did vary, the average dose did not differ between positive and negative trials, and no clear relationship could be extracted regarding effect, dose, and application sites. Pain intensity reports from negative trials were considered adequate and not a cause of possible insensitivity. Furthermore, no major difference was observed in the quality scores between positive and negative trials of intraperitoneal local anesthetics. The CO2 insufflation pressure, which may relate to abdominal pain (66,67), did not differ much between trials (ranging 10–15 mm Hg). However, in none of the negative studies was power analysis of the statistical tests performed and small sample sizes in some of these trials (31,32,35) may have rendered these insensitive. One editorial suggested that timing of the local anesthetic administration may be of importance, and that preoperative or pre- and postoperative administration should be better than postoperative administration (69). However, although the local anesthetic in all negative trials was administered at the end of the procedure, it was also administered at the end of the procedure in more than one-half of the positive treatment arms, and in only one study was a direct comparison of pre- versus postoperative administration performed (25). Therefore, no firm conclusion regarding timing of the administration can be made. Regarding dosage of the local anesthetic, a significant dose-response relationship was observed in the studies by Pasqualucci et al. (24,25). Therefore, not surprisingly, the amount of local anesthetic used may be of importance.
Port-site Infiltration
Data from the results of incisional local anesthetics did not provide evidence for any important effect of port-site infiltration, either in the qualitative or in the quantitative analysis. Again, no clear differences and relationships were observed in dose and application sites between positive and negative trials. Although there was a general lack of statistical power analysis in negative trials, sample sizes appeared adequate. An obvious explanation would be that intraabdominal pain may blur any possible improvements in incisional pain. However, in a recent trial of a large-dose, somato-visceral, local anesthetic block after laparoscopic cholecystectomy, incisional pain, not intraabdominal or shoulder pain, was reduced, and incisional pain dominated in the control group (68). It may, therefore, be unexpected that no more obvious positive results were obtained. In open abdominal procedures, incisional local anesthetics are most promising after small procedures, such as hernia repair (1), and analogous results might have been expected with the limited somatic trauma associated with laparoscopic surgery. Although not obvious in this review, application site may be of importance, because a previous study showed 20 mL of 0.5% bupivacaine infiltrated subcutaneously and into the parietal peritoneum to be more effective than only subcutaneous infiltration after laparoscopic cholecystectomy (70). In conclusion, there is still no evidence for any major effect of port-site infiltration with local anesthetics.
Mesosalpinx/fallopian Tube Block
From the qualitative and quantitative analyses, evidence was obtained for a mesosalpinx or fallopian tube block to clinically improve pain relief after laparoscopic sterilization in the immediate postoperative period. This has been shown in trials published more than a decade ago and confirmed in trials performed up through the 1990s, although it may be surprising that simply dripping local anesthetics on the fallopian tubes can provide pain alleviation (23,47,49,50,55). The pain relief, although short-lasting, may be of importance, especially because this is often a day-case procedure. On the other hand, the obtainable pain relief also provides dangers and challenges as late postoperative pain may recur after patient discharge, when the possibly ischemia-provoked pain from the fallopian tubes may become aggravated and dominate. Although there is clear evidence for a clinically important effect, the short-duration of this treatment will in most circumstances only postpone, not eliminate, the need for supplemental analgesics, and thus, should only be viewed as a supplement, not a replacement, for other traditional pain treatment.
Combined Application Sites
If only marginal effects are obtainable with intraperitoneal instillation, port-site infiltration, or visceral infiltration per se, perhaps combining these techniques would provide clinically relevant pain relief. Three of four trials with different combinations of peripheral local anesthetic use showed improved pain relief early and also up to >24 h after laparoscopy. Only the study by Cook and Lambert (56) showed no effect from port-site and a fallopian-tube block. However, pain was only assessed at one-half, 7, and 17 h postoperatively, and an early effect, within 4–6 h after laparoscopy, may have been overlooked. Most convincing was the study by Callesen et al. (59) in which intraperitoneal instillation, mesosalpinx, and port-site infiltration with a large dose of ropivacaine almost abolished postoperative pain up to 4 h after surgery.
In all of these trials, laparoscopic procedures were gynecological, diagnostic, or sterilization (56–59). Except for one recent paper of a combined somato-visceral local anesthetic block after laparoscopic cholecystectomy (68), in which overall pain and incisional pain was improved up to 4 h postoperatively, there is a lack of data for combined techniques with large-dose local anesthetics in other procedures, and therefore, this is an obvious issue for research.
Side Effects and Plasma Concentration
In less than a third of all reviewed trials, constituting approximately 600 of 2800 patients, information about possible side effects was provided, and in no case were they attributable to the local anesthetic. However, in no trial were possible side effects a main variable, and this may impair the validity of such information. Even fewer studies provided information about plasma concentrations of local anesthetics, which may, apart from total dosages, depend on site of application (60). However, from reviewed trials, there was only one reported patient achieving a maximum plasma concentration above the presumed toxic plasma concentration of 2–4 µg/mL of bupivacaine after intraperitoneal instillation (60). Therefore, reported doses, ranging up to approximately 150 mg of bupivacaine, may be presumed to be fairly safe. There is, however, a need for more pharmacokinetic data, especially after intraperitoneal use, of large-dose local anesthetics, with and without added epinephrine.
In conclusion there is weak and not compelling evidence for a postoperative analgesic effect of intraperitoneal local anesthetics after laparoscopic cholecystectomy and other laparoscopic procedures. The clinical importance may be questioned. There is a lack of evidence for port-site infiltration with local anesthetics for postoperative pain treatment to have any important pain-reducing effect after laparoscopic surgery. In contrast, there is clear evidence for mesosalpinx block or tubal application with local anesthetics after laparoscopic sterilization to improve postoperative pain immediately after surgery, however, this effect is short-lived. Finally, it appears that combining the various techniques may reduce postoperative pain further; however, data are too sparse for final conclusions. There is also a lack of data for comparing various techniques.
The data presented in this review indicate a need for more large-scale, large-dose pharmacokinetic studies and trials of combined large-dose, somato-visceral local anesthetic block in different laparoscopic procedures to reduce postoperative discomfort. As a part of a multimodal pain treatment it may, together with accelerated convalescence regimens, be possible to gain the full advantage of these minimally invasive techniques. 
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