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妇科腹腔镜手术后减少阿片类药物处方:一项随机对照试验。

Examining Reduced Opioid Prescriptions after Gynecologic Laparoscopy: A Randomized Controlled Trial.

机构信息

Division of Minimally Invasive Gynecologic Surgery, Department of Obstetrics and Gynecology and Women's Health, Montefiore Medical Center (Drs. Plewniak, Kintzer, and Shin).

Division of Minimally Invasive Gynecologic Surgery, Department of Obstetrics and Gynecology and Women's Health, Montefiore Medical Center (Drs. Plewniak, Kintzer, and Shin).

出版信息

J Minim Invasive Gynecol. 2021 Feb;28(2):366-373. doi: 10.1016/j.jmig.2020.07.001. Epub 2020 Jul 9.

Abstract

STUDY OBJECTIVE

To examine whether prescribing 5 tablets, as opposed to 10 tablets, of 5-mg oxycodone adequately treats pain after gynecologic laparoscopy.

DESIGN

Single-blinded randomized trial.

SETTING

Academically affiliated ambulatory surgery center.

PATIENTS

One hundred twenty women scheduled to undergo minor gynecologic laparoscopy.

INTERVENTIONS

Patients scheduled for ambulatory gynecologic laparoscopy were allocated to the standard tablet or low-tablet number prescription groups (10 tablets or 5 tablets of 5-mg oxycodone). The patients also received prescriptions for acetaminophen and ibuprofen.

MEASUREMENTS AND MAIN RESULTS

Telephone surveys were conducted on postoperative days 1 and 7 to assess medication use and pain. The primary outcome was the number of oxycodone tablets used by days 1 and 7. Prespecified secondary outcomes included unscheduled patient contacts and pain scores. With N = 50 in each group and assuming standardized effect sizes, the study was powered to detect a 0.6 difference or greater when comparing the primary outcome between the groups. Forty-five and 47 patients in the 5-tablet and 10-tablet groups, respectively, completed the day-7 survey. The median number of oxycodone tablets taken by day 7 was 2.0 (interquartile range 0.0, 4.0) in the 5-tablet group and 2.5 (interquartile range 0.0, 5.0) in the 10-tablet group (p = .36). Most of the patients in both groups reported taking 3 oxycodone tablets or fewer by day 7. There were no significant differences in unscheduled patient contacts, need for additional prescriptions, or pain scores. There were significantly fewer unused tablets in the 5-tablet group by day 7.

CONCLUSION

Prescribing 5 tablets of 5-mg oxycodone, acetaminophen, and ibuprofen is likely sufficient for most patients after minor laparoscopic surgery.

摘要

研究目的

探讨相较于开 10 片 5 毫克羟考酮片剂,开 5 片羟考酮片剂能否充分缓解妇科腹腔镜手术后的疼痛。

设计

单盲随机试验。

地点

学术附属门诊手术中心。

患者

120 名计划行小妇科腹腔镜手术的女性。

干预措施

计划行门诊妇科腹腔镜手术的患者被分配到标准片剂或低片剂数量处方组(开 10 片或 5 片 5 毫克羟考酮片剂)。患者还收到了对乙酰氨基酚和布洛芬的处方。

测量和主要结果

术后第 1 天和第 7 天通过电话调查评估用药情况和疼痛。主要结局是第 1 天和第 7 天使用羟考酮片剂的数量。规定的次要结局包括非计划患者联系和疼痛评分。每组 N=50,如果假设标准化效应量,该研究有能力检测出两组间主要结局的 0.6 差异或更大差异。5 片组和 10 片组分别有 45 名和 47 名患者完成了第 7 天的调查。第 7 天,5 片组服用羟考酮片剂的中位数为 2.0(四分位距 0.0,4.0),10 片组为 2.5(四分位距 0.0,5.0)(p=0.36)。两组中大多数患者在第 7 天报告服用 3 片羟考酮或更少的羟考酮。非计划患者联系、需要额外处方或疼痛评分均无显著差异。第 7 天,5 片组未使用的片剂明显较少。

结论

对于大多数小腹腔镜手术后的患者,开 5 片 5 毫克羟考酮、对乙酰氨基酚和布洛芬可能就足够了。

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