经腹腔镜子宫切除术术后使用酒石酸布托啡诺与羟考酮镇痛效果和不良反应的随机对照试验。

Tapentadol versus oxycodone analgesia and side effects after laparoscopic hysterectomy: A randomised controlled trial.

机构信息

From the Division of Emergencies and Critical Care, Department of Anaesthesiology, Oslo University Hospital (MC, JR, HL), Faculty of Medicine, Institute of Clinical Medicine, University of Oslo (MC, JR, TD, ML, HL), Division of Emergencies and Critical Care, Department of Research and Development (TD) and Division of Gynaecology and Obstetrics, Oslo University Hospital, Oslo, Norway (ML).

出版信息

Eur J Anaesthesiol. 2021 Sep 1;38(9):995-1002. doi: 10.1097/EJA.0000000000001425.

DOI:10.1097/EJA.0000000000001425

PMID:33428347

Abstract

BACKGROUND

Tapentadol is an opioid, which acts as a μ-opioid receptor agonist and inhibits noradrenaline reuptake in the central nervous system. This dual mechanism of action results in synergistic analgesic effects and potentially less side effects. This has been shown in treatment of chronic pain but postoperative studies are sparse.

OBJECTIVES

The main aim was to compare the analgesic effect of tapentadol with oxycodone after laparoscopic hysterectomy. Opioid side effects were recorded as secondary outcomes.

DESIGN

Randomised, blinded trial.

SETTING

Single-centre, Oslo University Hospital, Norway, December 2017 to February 2019.

PATIENTS

Eighty-six opioid-naïve American Society of Anesthesiologists physical status 1 to 3 women undergoing laparoscopic hysterectomy for nonmalignant conditions.

INTERVENTION

The patients received either oral tapentadol (group T) or oxycodone (group O) as part of multimodal pain treatment. Extended-release study medicine was administered 1 h preoperatively and after 12 h. Immediate-release study medicine was used as rescue analgesia.

MAIN OUTCOME MEASURES

Pain scores, opioid consumption and opioid-induced side effects were evaluated during the first 24 h after surgery.

RESULTS

The groups scored similarly for pain at rest using a numerical rating scale (NRS) 1 h postoperatively (group T 4.4, 95% CI, 3.8 to 5.0, group O 4.6, 95% CI, 3.8 to 5.3). No statistically significant differences were found between the groups for NRS at rest or while coughing during the 24-h follow-up period (P = 0.857 and P = 0.973). Mean dose of oral rescue medicine was similar for the groups (P = 0.914). Group T had significantly lower odds for nausea at 2 and 3 h postoperatively (P = 0.040, P = 0.020) and less need for antiemetics than group O. No differences were found for respiratory depression, vomiting, dizziness, pruritus, headache or sedation.

CONCLUSION

We found tapentadol to be similar in analgesic efficacy to oxycodone during the first 24 h after hysterectomy, but with significantly less nausea.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT03314792.

摘要

背景

曲马多是一种阿片类药物，作为μ-阿片受体激动剂和抑制去甲肾上腺素再摄取在中枢神经系统。这种双重作用机制导致协同的镇痛效果，并可能减少副作用。这在慢性疼痛的治疗中已经得到证实，但术后研究很少。

目的

比较曲马多与羟考酮在腹腔镜子宫切除术后的镇痛效果。记录阿片类药物的副作用作为次要结果。

设计

随机、双盲试验。

地点

单中心，挪威奥斯陆大学医院，2017 年 12 月至 2019 年 2 月。

患者

86 例非恶性疾病接受腹腔镜子宫切除术的美国麻醉医师协会身体状况 1 至 3 级的阿片类药物初治妇女。

干预措施

患者接受口服曲马多（T 组）或羟考酮（O 组）作为多模式镇痛治疗的一部分。术前 1 小时和 12 小时给予延长释放研究药物。立即释放研究药物用作解救性镇痛。

主要观察指标

术后 24 小时内评估疼痛评分、阿片类药物消耗和阿片类药物引起的副作用。

结果

两组术后 1 小时静息时疼痛评分相似（T 组 4.4，95%置信区间 3.8 至 5.0，O 组 4.6，95%置信区间 3.8 至 5.3）。在 24 小时随访期间，两组静息或咳嗽时 NRS 无统计学差异（P=0.857 和 P=0.973）。两组口服解救药物的平均剂量相似（P=0.914）。T 组术后 2 小时和 3 小时恶心的可能性显著低于 O 组（P=0.040，P=0.020），需要使用止吐药的次数也少于 O 组。两组在呼吸抑制、呕吐、头晕、瘙痒、头痛或镇静方面无差异。