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腹腔镜结肠切除术多模式镇痛中无阿片类药物与阿片类药物保留策略的比较:一项随机对照试验。

Opioid free versus opioid sparing strategies for multimodal antinociception during laparoscopic colectomy: a randomised controlled trial.

机构信息

Department of Anesthesiology, Medipole Villeurbanne Hospital, Villeurbanne, France.

Department of Anesthesiology, Hopital de la Croix Rousse, Lyon, France.

出版信息

Anaesth Crit Care Pain Med. 2024 Dec;43(6):101436. doi: 10.1016/j.accpm.2024.101436. Epub 2024 Oct 9.

Abstract

BACKGROUND

It remains unclear whether opioid-free anesthesia (OFA), when compared to opioid-sparing anesthesia (OSA), reduces postoperative opioid consumption while still providing adequate pain control. We thus tested the hypothesis that patients having an OFA strategy during laparoscopic colectomy would require less postoperative opioids when compared to an OSA strategy.

METHODS

This single-center, prospective randomized controlled superiority trial, randomly allocated consecutive patients undergoing laparoscopic colectomy to receive either sevoflurane-dexmedetomidine anesthesia with a continuous infusion of lidocaine and ketamine (OFA group) or sevoflurane-sufentanil boluses anesthesia with a continuous infusion of lidocaine (OSA group). Both groups received multimodal antinociception with boluses of dexamethasone, lidocaine, and ketamine during anesthesia induction, as well as acetaminophen, ketoprofen, and nefopam before the end of the surgery. OFA patients also received a dose of magnesium sulfate during induction. The primary outcome was cumulative opioid consumption at 48 h after surgery, expressed in oral morphine equivalents (OME). Secondary exploratory outcomes were pain scores, opioid-related adverse events, and patient quality of life (WHODAS score).

RESULTS

Of the 160 randomized patients, 155 were included in a modified intention-to-treat analysis. Median [Q1-Q3] OME consumption at 48 h after surgery did not differ between groups (9 [0-30] mg for OFA vs. 14 [0-30] mg for OSA; p = 0.861). Key secondary outcomes were not different between groups except a three time higher incidence of bradycardia in the OFA group.

CONCLUSIONS

In patients undergoing laparoscopic colectomy with a multimodal antinociception protocol, OFA, when compared to OSA, did not decrease postoperative opioid consumption.

CLINICAL TRIAL REGISTRY AND NUMBER

NCT05031234.

摘要

背景

目前仍不清楚与阿片类药物节省麻醉(OSA)相比,无阿片类药物麻醉(OFA)是否可以在提供足够疼痛控制的同时减少术后阿片类药物的消耗。因此,我们测试了以下假设:与 OSA 策略相比,接受腹腔镜结肠切除术的 OFA 策略患者术后需要的阿片类药物更少。

方法

这是一项单中心前瞻性随机对照优效性试验,将连续接受腹腔镜结肠切除术的患者随机分为接受七氟醚-右美托咪定麻醉加持续输注利多卡因和氯胺酮(OFA 组)或七氟醚-舒芬太尼推注麻醉加持续输注利多卡因(OSA 组)。两组患者在麻醉诱导时均接受地塞米松、利多卡因和氯胺酮推注进行多模式镇痛,在手术结束前还接受对乙酰氨基酚、酮咯酸和奈福泮。OFA 患者在诱导时还接受硫酸镁剂量。主要结局是术后 48 小时内累积阿片类药物消耗量,以口服吗啡当量(OME)表示。次要探索性结局是疼痛评分、阿片类药物相关不良事件和患者生活质量(WHODAS 评分)。

结果

在 160 名随机患者中,155 名患者被纳入改良意向治疗分析。术后 48 小时 OME 消耗量中位数[Q1-Q3]在两组之间无差异(OFA 组为 9 [0-30]mg,OSA 组为 14 [0-30]mg;p=0.861)。次要结局除 OFA 组心动过缓发生率高 3 倍外,两组之间无差异。

结论

在接受多模式镇痛方案的腹腔镜结肠切除术患者中,与 OSA 相比,OFA 并未减少术后阿片类药物的消耗。

临床试验注册号和名称

NCT05031234。

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