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普瑞巴林改善减重手术术后恢复:一项平行、随机、双盲、安慰剂对照研究。

Pregabalin to improve postoperative recovery in bariatric surgery: a parallel, randomized, double-blinded, placebo-controlled study.

作者信息

Martins Marcelo J, Martins Caroline Paiva Matos Oliveira, Castro-Alves Lucas J, Jesus Gabriel Nascimento, Campos Guilherme Oliveira, Sacramento Breno Barbosa Cerqueira, Borges Leonardo Ferrari, Mello Carlos Augusto Bastos, Alves Rodrigo Leal, Módolo Norma Sueli Pinheiro

机构信息

Department of Anesthesiology, São Paulo State University (UNESP), São Paulo, Brazil,

Department of Anesthesiology at Federal University of Bahia, Bahia, Brazil.

出版信息

J Pain Res. 2018 Oct 17;11:2407-2415. doi: 10.2147/JPR.S176468. eCollection 2018.

Abstract

PURPOSE

Obesity has been considered as a major public health problem in developed countries for which bariatric surgery has become an important treatment strategy. Postoperative pain, however, is a frequent problem in postoperative management. Pregabalin blocks the development of hyperalgesia and central pain sensitization. The objective of this randomized, placebo-controlled, double-blinded trial was to evaluate the effect of a single dose of preoperative pregabalin vs placebo on the quality of postoperative recovery in patients undergoing bariatric surgery.

PATIENTS AND METHODS

A total of 70 patients undergoing abdominal gastroplasty were randomly assigned to receive oral pregabalin (75 mg) or an identical placebo 1 hour before surgery. The primary outcome was Quality of Recovery-40 (QoR-40) score at 24 hours. Secondary outcomes included opioid consumption and postoperative pain scores. <0.05 was considered to indicate statistical significance.

RESULTS

In all, 60 of the 70 patients completed the study. The mean (SD) global recovery scores (QoR-40) 24 hours after surgery in the pregabalin and control groups were 183.7 (9) and 182.1 (12), respectively (mean difference=1.6, 95% CI -7.36 to 4.2, =0.59). There was no significant difference in the total opioid consumption in the 24 hours following surgery between the two groups (pregabalin vs control=0.47×0.2; mean difference=0.26, 95% CI -0.24 to 0.77, =0.3). There were no significant differences in nausea, vomiting, or time to postanesthesia care unit discharge between the two groups.

CONCLUSION

In patients who underwent bariatric surgery, a single preoperative dose of pregabalin (75 mg) did not improve pain relief, quality of postoperative recovery, or reduction in opioid consumption.

CLINICAL TRIAL REGISTRATION

http://www.ensaiosclinicos.gov.br (identifier: RBR-2g89x8).

摘要

目的

肥胖在发达国家被视为一个主要的公共卫生问题,对此减肥手术已成为一项重要的治疗策略。然而,术后疼痛是术后管理中常见的问题。普瑞巴林可阻止痛觉过敏和中枢性疼痛敏化的发展。这项随机、安慰剂对照、双盲试验的目的是评估单剂量术前普瑞巴林与安慰剂相比,对接受减肥手术患者术后恢复质量的影响。

患者与方法

总共70例接受腹部胃成形术的患者被随机分配,在手术前1小时口服普瑞巴林(75毫克)或相同的安慰剂。主要结局是术后24小时的恢复质量-40(QoR-40)评分。次要结局包括阿片类药物消耗量和术后疼痛评分。P<0.05被认为具有统计学意义。

结果

70例患者中共有60例完成了研究。普瑞巴林组和对照组术后24小时的平均(标准差)总体恢复评分(QoR-40)分别为183.7(9)和182.1(12)(平均差值=1.6,95%CI -7.36至4.2,P=0.59)。两组术后24小时内阿片类药物总消耗量无显著差异(普瑞巴林组与对照组=0.47×0.2;平均差值=0.26,95%CI -0.24至0.77,P=0.3)。两组在恶心、呕吐或离开麻醉后护理单元的时间方面无显著差异。

结论

在接受减肥手术的患者中,术前单剂量普瑞巴林(75毫克)并未改善疼痛缓解、术后恢复质量或减少阿片类药物消耗量。

临床试验注册

http://www.ensaiosclinicos.gov.br(标识符:RBR-2g89x8)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a27b/6200430/6db4ec0eef39/jpr-11-2407Fig1.jpg

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