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KSR Number: KSRA95789

Interventions for intra‐operative pain relief during postpartum mini‐laparotomy tubal ligation

  • Cochrane Database Syst Rev 2019, 2, CD011807, 10.1002/14651858.CD011807.pub2
  • Full report

Risk of Bias Assessment

Overall summary: Low risk of bias in the review

Bottom Line

Limited evidence suggests that EMLA cream may reduce pain during abdominal entry compared to placebo, and that subsequent intraperitoneal instillation of lidocaine may improve pain control (and reduce rescue pain medication use) compared to placebo or intramuscular morphine during post-partum mini-laparotomy tubal ligation. Evidence also suggests that the adverse event profile may be similar for intraperitoneal lidocaine vs. placebo. No methodological issues were identified in the review. Further large, high-quality trials are required to determine the effects of combination intraperitoneal anaesthesia with other local anaesthesia as a multimodal pain management strategy during post-partum mini-laparotomy tubal ligation.

Risk of Bias Assessment

Overall summary Low risk of bias in the review

Low

All domains were considered at low concern.

A. Did the interpretation of findings address all of the concerns identified in Domains 1 to 4? Probably yes
B. Was the relevance of identified studies to the review's research question appropriately considered? Probably yes
C. Did the reviewers avoid emphasizing results on the basis of their statistical significance? Probably yes
Risk of bias in the review Low

Details of Review

Number of studies 3
Number of participants 230
Last search date 31st October 2018
Review type Intervention
Objective To assess the effectiveness and safety of interventions for pain relief in women undergoing post-partum mini‐laparotomy tubal ligation.
Population Women undergoing post-partum mini‐laparotomy tubal ligation under local anaesthesia.
Interventions Any intervention for intraoperative pain relief during postpartum mini‐laparotomy tubal ligation, including: lidocaine injection into the mesosalpinx, intraperitoneal instillation of lidocaine, oral administration of non-steroidal anti-inflammatory drugs and intramuscular morphine injection).
Comparator Another intervention for pain relief, placebo or no treatment.
Outcome Primary outcomes: pain during the postpartum mini‐laparotomy tubal ligation procedure.

Secondary outcomes: adverse effects (such as nausea, vomiting, urinary retention or perioral numbness); requirement for additional medication, regional anaesthesia or general anaesthesia to complete the postpartum mini‐laparotomy tubal ligation procedure.
Study design Randomised controlled trials.

Results

In terms of pain associated with abdominal entry, a single study reported that pain was reduced with EMLA cream compared to placebo during post-partum mini-laparotomy tubal ligation (PPMLTL) (mean difference [MD] 3.18, 95% confidence interval [CI] -4.10 to -2.26; 1 study, n=90 participants).

In terms of intraperitoneal pain, pooled analysis reported an improvement in intaperitoneal pain following lidocaine intraperitoneal instillation compared to placebo (MD -3.34, 95% CI -4.19 to -2.49; 3 studies, n=190 participants). A single study reported no difference in intraperitoneal pain for intramuscular morphine compared to placebo (MD 0.50, 95% CI -1.33 to 2.33; 1 study, n=40 participants). A single study reported a reduction in intraperitoneal pain for lidocaine intraperitoneal instillation compared to intramuscular morphine (MD -4.80, 95% CI -6.43 to -3.17, 1 study, n=40 participants). A single study reported a reduction in intraperitoneal pain for lidocaine plus morphine compared to placebo (MD -4.70, 95% CI -6.09 to -3.31; 1 study, n=40 participants). A single study reported no difference in intraperitoneal pain for lidocaine plus morphine compared to lidocaine alone (MD -0.40, 95% CI -1.52 to 0.72; 1 study, n=40 participants). A single study reported a reduction in intraperitoneal pain for lidocaine plus morphine compared to morphine alone (MD -5.20, 95% CI -6.63 to -3.77; 1 study, n=40 participants).

In terms of rescue medication use, a single study reported that fewer women required lidocaine rescue medication after receiving EMLA cream during abdominal entry compared to placebo (risk ratio [RR] 0.36, 95% CI 0.25 to 0.53; 1 study, n=90 participants). Pooled analysis reported a reduction in the number of women requiring rescue medication following intraperitoneal lidocaine instillation compared to placebo (RR 0.27, 95% CI 0.17 to 0.44; 3 studies, n=190 participants). A single study reported no difference in the number of women requiring rescue medication for intramuscular morphine compared to placebo (RR 1.00, 95% CI 0.81 to 1.23; 1 study, n=40 participants). A single study reported a reduction in the number of women requiring rescue medication for lidocaine intraperitoneal instillation compared to intramuscular morphine (RR 0.22, 95% CI 0.09 to 0.54; 1 study, n=40 participants). A single study reported a reduction in rescue medication use for lidocaine plus morphine compared to placebo (RR 0.11, 95% CI 0.03 to 0.42; 1 study, n=40 participants). A single study reported no difference in rescue medication use for lidocaine plus morphine compared to lidocaine alone (RR 0.50, 95% CI 0.10 to 2.43; 1 study, n=40 participants). A single study reported a reduction in rescue medication use for lidocaine plus morphine compared to morphine alone (RR 0.11, 95% CI 0.03 to 0.42; 1 study, n=40 participants).

In terms of adverse events, pooled analysis reported no difference in adverse events for intraperitoneal lidocaine installation compared to placebo (RR 1.04, 95% CI 0.40 to 2.69; 2 studies, n=150 participants).

Full Risk of Bias Assessment

The research objective was clearly stated and appropriate inclusion criteria were defined. No restrictions were imposed based on study characteristics or sources of information.

1.1 Did the review adhere to pre-defined objectives and eligibility criteria? Probably yes
1.2 Were the eligibility criteria appropriate for the review question? Probably yes
1.3 Were eligibility criteria unambiguous? Probably yes
1.4 Were all restrictions in eligibility criteria based on study characteristics appropriate (e.g. date, sample size, study quality, outcomes measured)? Probably yes
1.5 Were any restrictions in eligibility criteria based on sources of information appropriate (e.g. publication status or format, language, availability of data)? Probably yes
Concerns regarding specification of study eligibility criteria Low

CENTRAL, MEDLINE, EMBASE, PsycINFO, CINAHL EBSCO, ClinicalTrials.gov, and ICTRP were searched for relevant studies. Additionally, the authors searched Greynet.org, WorldCat Dissertations and theses to identify relevant unpublished and grey literature. The authors handsearched the references of included studies in order to identify additional relevant studies. The search strategy was reported in full and appeared adequate. There were no restrictions based on date, publication format or language. Two reviewers independently judged the study eligibility, and disagreements were resolved by discussion or through consultation with a third reviewer.

2.1 Did the search include an appropriate range of databases/electronic sources for published and unpublished reports? Yes
2.2 Were methods additional to database searching used to identify relevant reports? Yes
2.3 Were the terms and structure of the search strategy likely to retrieve as many eligible studies as possible? Yes
2.4 Were restrictions based on date, publication format, or language appropriate? Yes
2.5 Were efforts made to minimise error in selection of studies? Probably yes
Concerns regarding methods used to identify and/or select studies Low

Two review authors independently extracted the data from eligible studies, and discrepancies were resolved by discussion or through consultation with a third reviewer. Data was also verified by a third reviewer. Sufficient individual study characteristics have been extracted to allow interpretation of results. Relevant study results appear to have been extracted. Methodological quality assessment of included studies was performed using the Cochrane Risk of Bias Tool for randomised controlled trials. Two review authors independently assessed the risk of bias for each study, and disagreements were resolved by discussion or through consultation with a third reviewer.

3.1 Were efforts made to minimise error in data collection? Probably yes
3.2 Were sufficient study characteristics considered for both review authors and readers to be able to interpret the results? Probably yes
3.3 Were all relevant study results collected for use in the synthesis? Probably yes
3.4 Was risk of bias (or methodological quality) formally assessed using appropriate criteria? Probably yes
3.5 Were efforts made to minimise error in risk of bias assessment? Probably yes
Concerns regarding methods used to collect data and appraise studies Low

The synthesis appeared to include all relevant studies. The method of analysis was explained and appeared appropriate. Heterogeneity was assessed and found to be low for all outcomes. Neither subgroup nor sensitivity analyses were feasible due to the small number of included studies. Publication bias was not assessed due to the small number of included studies; this was considered appropriate. Bias in primary studies was addressed while interpreting the findings.

4.1 Did the synthesis include all studies that it should? Probably yes
4.2 Were all pre-defined analyses reported or departures explained? Probably yes
4.3 Was the synthesis appropriate given the degree of similarity in the research questions, study designs and outcomes across included studies? Probably yes
4.4 Was between-study variation minimal or addressed in the synthesis? Probably yes
4.5 Were the findings robust, e.g. as demonstrated through funnel plot or sensitivity analyses? Probably yes
4.6 Were biases in primary studies minimal or addressed in the synthesis? Probably yes
Concerns regarding synthesis and findings Low

Abstract

Abstract - Background Postpartum mini‐laparotomy tubal ligation (PPTL) is a contraceptive method that works by interrupting the patency of the fallopian tubes. Several methods are used for intraoperative pain relief, such as systemic administration of opioids or intraperitoneal instillation of lidocaine. Objectives To evaluate the effectiveness of and adverse effects associated with interventions for pain relief in women undergoing PPTL. Search methods We searched for eligible studies published on or before 31 July 2017 in the CENTRAL Register of Studies Online, MEDLINE, Embase, PsycINFO, and CINAHL. We examined review articles and searched registers of ongoing clinical trials, citation lists of included studies, key textbooks, grey literature, and previous systematic reviews for potentially relevant studies. Selection criteria We included randomised controlled trials (RCT) that compared perioperative pain relief measures during PPTL. Data collection and analysis Two review authors independently assessed the titles, abstracts, and full‐text articles of potentially relevant studies for inclusion. We extracted the data from the included studies, assessed risk of bias, and calculated and compared results. Discrepancies were resolved by discussion, or by consulting a third review author. We computed the inverse variance risk ratio (RR) with 95% confidence interval (CI) for binary outcomes, and the mean difference (MD) with 95% CI for continuous variables. Main results We found only three RCTs, in which a total of 230 postpartum women participated. Most of our analyses were based on relatively small numbers of patients and studies. Overall, the certainty of evidence regarding the effectiveness of interventions was low, due to risk of bias and imprecision. We found very low‐certainty evidence regarding the safety of interventions because of risk of bias and imprecision. Two studies had unclear risk of selection bias. One study had unclear risk of reporting bias and a high risk of other bias associated with the study protocol. Women who received an intraperitoneal instillation of lidocaine experienced lower intensity intraperitoneal pain than those given a placebo (pooled MD ‐3.34, 95% CI ‐4.19 to ‐2.49, three studies, 190 participants, low‐certainty evidence), or an intramuscular injection of morphine (MD ‐4.8, 95% CI ‐6.43 to ‐3.17, one study, 40 participants, low‐certainty evidence). We found no clear difference in intraperitoneal pain between women who had an intramuscular injection of morphine added to an intraperitoneal instillation of lidocaine and those who had an intraperitoneal instillation of lidocaine alone (MD ‐0.40, 95% CI ‐1.52 to 0.72, one study, 40 participants, low‐certainty evidence). An intramuscular injection of morphine alone was not effective for intraperitoneal pain relief compared to placebo (MD 0.50, 95% CI ‐1.33 to 2.33, one study, 40 women, low‐certainty evidence). None of the studies reported any serious adverse events but the evidence was very low‐certainty. Intraperitoneal instillation of lidocaine may reduce the number of women requiring additional pain control when compared to placebo (RR 0.27, 95% CI 0.17 to 0.44, three studies, 190 women, low‐certainty evidence). Authors' conclusions An intraperitoneal instillation of lidocaine during postpartum mini‐laparotomy tubal ligation before fallopian tubes were tied may offer better intraperitoneal pain control, although the evidence regarding adverse effects is uncertain. We found no clear difference in intraperitoneal pain between women who received a combination of an injection of morphine, and intraperitoneal instillation of lidocaine and those who received an intraperitoneal instillation of lidocaine alone. These results must be interpreted with caution, since the evidence overall was low to very low‐certainty. Plain language summary Interventions for intra‐operative pain relief during postpartum mini‐laparotomy tubal ligation Review question The aim of this review was to compare interventions for i traoperative pain relief with other interventions or no intervention, during mini‐laparotomy (small surgical incision through the abdominal wall) tubal ligation (uterine tubes tied) after delivery. Background Tubal ligation is a permanent form of birth control during which a woman's uterine tubes are surgically cut or blocked off, to prevent pregnancy. This surgery can be done through a mini‐laparotomy. There are various methods used for pain relief during a mini‐laparotomy tubal ligation. Some methods of pain relief include an injection of nonsteroidal anti‐inflammatory drugs (a class of medication that can reduce pain and fever), opioids (a class of medications related in structure to opium), or pouring lidocaine (a medication used to numb tissue in a specific area) into the abdominal cavity. Study characteristics We included three randomised controlled trials involving a total of 230 women. These studies compared lidocaine poured into the abdominal cavity with a placebo, or other treatments, such as an injection of morphine (also known as an opioid) into the muscle, or combination of lidocaine and morphine. All studies took place in Thailand. The evidence described here are from studies published before 31 July, 2017. Key results Pouring lidocaine into the abdominal cavity during a mini‐laparotomy tubal ligation before fallopian tubes were tied after delivery may offer better pain control than a placebo or morphine injection, although the evidence regarding adverse effects is uncertain. Women who received a combination of morphine injection and lidocaine poured into the abdominal cavity showed no clear difference in pain with those who received lidocaine alone. An injection of morphine into the muscle alone did not reduce pain more than a placebo. Certainty of the evidence 
 The certainty of evidence regarding the effectiveness of these interventions was low due to risk of bias and imprecision of results. The certainty of evidence regarding the safety of the interventions was very low because of risk of bias and imprecision.