Gurusamy Kurinchi Selvan, Vaughan Jessica, Toon Clare D, Davidson Brian R
Department of Surgery, Royal Free Campus, UCL Medical School, Royal Free Hospital, Rowland Hill Street, London, UK, NW3 2PF.
Cochrane Database Syst Rev. 2014 Mar 28;2014(3):CD008261. doi: 10.1002/14651858.CD008261.pub2.
While laparoscopic cholecystectomy is generally considered less painful than open surgery, pain is one of the important reasons for delayed discharge after day-surgery and overnight stay following laparoscopic cholecystectomy. The safety and effectiveness of different pharmacological interventions such as non-steroidal anti-inflammatory drugs, opioids, and anticonvulsant analgesics in people undergoing laparoscopic cholecystectomy is unknown.
To assess the benefits and harms of different analgesics in people undergoing laparoscopic cholecystectomy.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Science Citation Index Expanded, and the World Health Organization International Clinical Trials Registry Platform portal (WHO ICTRP) to March 2013 to identify randomised clinical trials of relevance to this review.
We considered only randomised clinical trials (irrespective of language, blinding, or publication status) comparing different pharmacological interventions with no intervention or inactive controls for outcomes related to benefit in this review. We considered comparative non-randomised studies with regards to treatment-related harms. We also considered trials that compared one class of drug with another class of drug for this review.
Two review authors collected the data independently. We analysed the data with both fixed-effect and random-effects models using Review Manager 5 analysis. For each outcome, we calculated the risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI).
We included 25 trials with 2505 participants randomised to the different pharmacological agents and inactive controls. All the trials were at unclear risk of bias. Most trials included only low anaesthetic risk people undergoing elective laparoscopic cholecystectomy. Participants were allowed to take additional analgesics as required in 24 of the trials. The pharmacological interventions in all the included trials were aimed at preventing pain after laparoscopic cholecystectomy. There were considerable differences in the pharmacological agents used and the methods of administration. The estimated effects of the intervention on the proportion of participants who were discharged as day-surgery, the length of hospital stay, or the time taken to return to work were imprecise in all the comparisons in which these outcomes were reported (very low quality evidence). There was no mortality in any of the groups in the two trials that reported mortality (183 participants, very low quality evidence). Differences in serious morbidity outcomes between the groups were imprecise across all the comparisons (very low quality evidence). None of the trials reported patient quality of life or time taken to return to normal activity. The pain at 4 to 8 hours was generally reduced by about 1 to 2 cm on the visual analogue scale of 1 to 10 cm in the comparisons involving the different pharmacological agents and inactive controls (low or very low quality evidence). The pain at 9 to 24 hours was generally reduced by about 0.5 cm (a modest reduction) on the visual analogue scale of 1 to 10 cm in the comparisons involving the different pharmacological agents and inactive controls (low or very low quality evidence).
AUTHORS' CONCLUSIONS: There is evidence of very low quality that different pharmacological agents including non-steroidal anti-inflammatory drugs, opioid analgesics, and anticonvulsant analgesics reduce pain scores in people at low anaesthetic risk undergoing elective laparoscopic cholecystectomy. However, the decision to use these drugs has to weigh the clinically small reduction in pain against uncertain evidence of serious adverse events associated with many of these agents. Further randomised clinical trials of low risk of systematic and random errors are necessary. Such trials should include important clinical outcomes such as quality of life and time to return to work in their assessment.
虽然腹腔镜胆囊切除术通常被认为比开放手术疼痛程度轻,但疼痛是日间手术延迟出院以及腹腔镜胆囊切除术后过夜住院的重要原因之一。不同药物干预措施(如非甾体类抗炎药、阿片类药物和抗惊厥镇痛药)在接受腹腔镜胆囊切除术患者中的安全性和有效性尚不清楚。
评估不同镇痛药在接受腹腔镜胆囊切除术患者中的益处和危害。
我们检索了Cochrane对照试验中心注册库(CENTRAL)、MEDLINE、EMBASE、科学引文索引扩展版以及世界卫生组织国际临床试验注册平台门户(WHO ICTRP),检索截至2013年3月,以识别与本综述相关的随机临床试验。
在本综述中,我们仅考虑比较不同药物干预措施与无干预或无活性对照在获益相关结局方面的随机临床试验(无论语言、盲法或发表状态如何)。对于与治疗相关的危害,我们考虑了非随机对照研究。我们还考虑了在本综述中比较一类药物与另一类药物的试验。
两位综述作者独立收集数据。我们使用Review Manager 5分析软件,采用固定效应模型和随机效应模型对数据进行分析。对于每个结局,我们计算风险比(RR)或均值差(MD)以及95%置信区间(CI)。
我们纳入了25项试验,共2505名参与者被随机分配至不同的药物制剂和无活性对照。所有试验的偏倚风险均不明确。大多数试验仅纳入了接受择期腹腔镜胆囊切除术且麻醉风险较低的患者。24项试验允许参与者根据需要服用额外的镇痛药。所有纳入试验中的药物干预措施均旨在预防腹腔镜胆囊切除术后的疼痛。所使用的药物制剂和给药方法存在相当大的差异。在报告了这些结局的所有比较中,干预措施对日间手术出院患者比例、住院时间或恢复工作所需时间的估计效果均不精确(证据质量极低)。在报告了死亡率的两项试验中的任何组中均无死亡病例(183名参与者,证据质量极低)。在所有比较中,各组之间严重并发症结局的差异均不精确(证据质量极低)。没有试验报告患者的生活质量或恢复正常活动所需时间。在涉及不同药物制剂和无活性对照的比较中,4至8小时时的疼痛在1至10厘米视觉模拟量表上通常降低约1至2厘米(证据质量低或极低)。在涉及不同药物制剂和无活性对照的比较中,9至24小时时的疼痛在1至10厘米视觉模拟量表上通常降低约0.5厘米(适度降低)(证据质量低或极低)。
有质量极低的证据表明,包括非甾体类抗炎药、阿片类镇痛药和抗惊厥镇痛药在内的不同药物制剂可降低接受择期腹腔镜胆囊切除术且麻醉风险较低患者的疼痛评分。然而,使用这些药物的决策必须权衡临床上疼痛的微小减轻与许多此类药物相关严重不良事件的不确定证据。有必要开展系统误差和随机误差风险较低的进一步随机临床试验。此类试验应在评估中纳入重要的临床结局,如生活质量和恢复工作时间。