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腹腔镜阑尾切除术中雾化镇痛(NALA):一项随机三盲安慰剂对照试验。

Nebulized analgesia during laparoscopic appendectomy (NALA): A randomized triple-blind placebo controlled trial.

作者信息

Baird Robert, Ingelmo Pablo, Wei Andrew, Meghani Yash, Perez Eduardo Vega, Pelletier Helene, Auer Grant, Mujallid Razaz, Emil Sherif, Laberge Jean-Martin, Puligandla Pramod, Shaw Kenneth, Poenaru Dan

机构信息

Department of Pediatric Surgery, The Montreal Children's Hospital, McGill University Health Centre.

Department of Pediatric Anesthesia, The Montreal Children's Hospital, McGill University Health Centre.

出版信息

J Pediatr Surg. 2019 Jan;54(1):33-38. doi: 10.1016/j.jpedsurg.2018.10.029. Epub 2018 Oct 5.

DOI:10.1016/j.jpedsurg.2018.10.029
PMID:30366723
Abstract

PURPOSE

Postoperative pain remains a considerable concern for patients and families. We assessed whether nebulized ropivacaine reduces morphine consumption and pain after laparoscopic appendectomy for uncomplicated appendicitis in children.

METHODS

Patients 7-17 years old with uncomplicated appendicitis were randomized to ropivacaine (intervention arm) or saline nebulization (placebo arm) at the onset of laparoscopy. Nonconsenting individuals were treated with standard care and invited to provide clinical data (baseline arm). The primary outcome was in-patient morphine utilization. Secondary outcomes included pain scores at multiple time-points, markers of recovery, operative times, and surgeon satisfaction. The trial was registered (NCT02624089).

RESULTS

Study enrollment was 116 patients over a 1-year period: Intervention (n = 43), Placebo (n = 39), Baseline (n = 34). No differences in baseline characteristics were noted between groups. No difference was noted in overall in-patient morphine consumption between randomized groups (0.31 vs. 0.35 mg/kg, p = 0.42) or between ropivacaine and baseline (0.31 vs. 0.277 mg/kg, p = 0.62). Although operative times were comparable between groups, 63% of surgeon respondents felt that nebulization obscured visualization.

CONCLUSION

Nebulized ropivacaine did not reduce postoperative morphine consumption or pain scores after laparoscopic appendectomy for simple appendicitis in children. Given that it decreases visualization and likely increases costs, nebulized administration of intraperitoneal analgesia does not appear warranted in this context.

TYPE OF STUDY

Treatment study.

LEVEL OF EVIDENCE

Level I.

摘要

目的

术后疼痛仍是患者及其家属相当关注的问题。我们评估了雾化罗哌卡因是否能减少儿童单纯性阑尾炎腹腔镜阑尾切除术后的吗啡用量及疼痛程度。

方法

7至17岁的单纯性阑尾炎患者在腹腔镜手术开始时被随机分为罗哌卡因组(干预组)或生理盐水雾化组(安慰剂组)。不同意参与的个体接受标准治疗,并被邀请提供临床数据(基线组)。主要结局指标是住院期间吗啡的使用量。次要结局指标包括多个时间点的疼痛评分、恢复指标、手术时间和外科医生满意度。该试验已注册(NCT02624089)。

结果

在1年期间共纳入116例患者:干预组(n = 43)、安慰剂组(n = 39)、基线组(n = 34)。各组间基线特征无差异。随机分组组间总体住院吗啡用量无差异(0.31 vs. 0.35 mg/kg,p = 0.42),罗哌卡因组与基线组间也无差异(0.31 vs. 0.277 mg/kg,p = 0.62)。尽管各组手术时间相当,但63%的外科医生受访者认为雾化会影响视野。

结论

对于儿童单纯性阑尾炎腹腔镜阑尾切除术后,雾化罗哌卡因并未减少术后吗啡用量或疼痛评分。鉴于其会降低视野清晰度且可能增加成本,在此情况下腹腔内镇痛的雾化给药似乎并无必要。

研究类型

治疗性研究。

证据级别

I级。

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