短期围手术期度洛西汀治疗对结肠切除术后疼痛的影响：一项随机对照临床试验。

The effects of a short-term perioperative duloxetine treatment on post-colectomy pain: A randomized, controlled clinical trial.

机构信息

Polydoro Ernani de São Thiago University Hospital, Federal University of Santa Catarina.

出版信息

J Clin Anesth. 2022 Nov;82:110948. doi: 10.1016/j.jclinane.2022.110948. Epub 2022 Aug 11.

DOI:10.1016/j.jclinane.2022.110948

PMID:35963028

Abstract

STUDY OBJECTIVE

To test the hypothesis that duloxetine reduces postoperative morphine consumption and pain intensity in patients undergoing major colonic surgeries.

DESIGN

Single-center, prospective, double-blinded, randomized, controlled trial.

SETTING

Tertiary university hospital, from December 2019 to September 2021.

PATIENTS

Sixty 18-85 years old, ASA I - III patients undergoing elective open major colonic surgeries were randomly allocated into duloxetine (duloxetine) or placebo (placebo) groups (n = 30 per group).

INTERVENTIONS

Duloxetine 60 mg or placebo was administered orally 2 h before and 24 h after surgery.

MEASUREMENTS

PCA morphine consumption, surgical pain at rest, and movement measured on 10-cm visual analog scales (VAS), Ramsay sedation scores, and the incidence of adverse effects potentially associated with duloxetine were assessed at patients' admission to the post-anesthesia care unit (PACU), 6, 24, and 48 h postoperatively (PO).

MAIN RESULTS

After adjusting for age, BMI, ASA physical status, education level, and incision type, no differences were found between groups in PCA morphine consumption 24 PO h (duloxetine = 5.44 ± 2.06 mg; placebo = 10.33 ± 2.06 mg, p = 0.62) or 48 h PO (duloxetine = 9.18 ± 2.06 mg, placebo = 12.93 ± 2.06, p = 1). Pain at rest also did not differ between groups at 24 h PO (duloxetine = 1.76 ± 0.67 cm; placebo = 1 ± 0.67 cm, p = 1) or at 48 h PO (duloxetine = 0.84 ± 0.67 cm; placebo = 0.49 ± 0.67 cm, p = 1). Similarly, groups did not differ regarding pain on movement at 24 h PO (duloxetine = 2.09 ± 0.68 cm; placebo = 1.80 ± 0.68, p = 1) or at 48 h PO (duloxetine = 1.16 ± 0.68 cm; placebo = 0.88 ± 0.68 cm, p = 1). Sedation scores and adverse effects also did not differ between groups.

CONCLUSION

Under this study's conditions, short-term duloxetine did not reduce total opioid consumption or pain intensity during the initial 48 h following major colon surgery.

摘要

研究目的

测试度洛西汀可减少行择期开腹大肠手术患者术后吗啡用量和疼痛强度这一假说。

设计

单中心、前瞻性、双盲、随机、对照试验。

设置

2019 年 12 月至 2021 年 9 月三级大学医院。

患者

60 例年龄 18-85 岁、ASA I-III 级的择期行开腹大肠手术患者，随机分为度洛西汀（度洛西汀）或安慰剂（安慰剂）组（每组 30 例）。

干预措施

术前 2 小时和术后 24 小时口服度洛西汀 60mg 或安慰剂。

测量

患者入麻醉后恢复室（PACU）时、术后 6、24 和 48 小时时使用 PCA 吗啡用量、静息时手术疼痛、10cm 视觉模拟量表（VAS）、 Ramsay 镇静评分和与度洛西汀相关的不良反应发生率进行评估。

主要结果

在调整年龄、BMI、ASA 身体状况、教育水平和切口类型后，两组间术后 24 小时 PCA 吗啡用量（度洛西汀=5.44±2.06mg；安慰剂=10.33±2.06mg，p=0.62）或 48 小时 PCA 吗啡用量（度洛西汀=9.18±2.06mg，安慰剂=12.93±2.06mg，p=1）均无差异。两组间静息时疼痛在术后 24 小时（度洛西汀=1.76±0.67cm；安慰剂=1±0.67cm，p=1）或术后 48 小时（度洛西汀=0.84±0.67cm；安慰剂=0.49±0.67cm，p=1）也无差异。同样，两组在术后 24 小时（度洛西汀=2.09±0.68cm；安慰剂=1.80±0.68cm，p=1）或术后 48 小时（度洛西汀=1.16±0.68cm；安慰剂=0.88±0.68cm，p=1）时运动时疼痛也无差异。镇静评分和不良反应也无差异。