前臂与上臂静脉区域麻醉（Bier 阻滞）的镇痛效果：一项随机对照非劣效性试验。

The analgesic efficacy of forearm versus upper arm intravenous regional anesthesia (Bier's block): A randomized controlled non-inferiority trial.

机构信息

Department of Anaesthesiology and Pain Medicine, Jessa Hospital, Hasselt, Belgium; UHasselt, Faculty of Medicine and Life Sciences, Diepenbeek, Belgium; KULeuven, Department of Cardiovascular Sciences, Leuven, Belgium; Department of Anaesthesiology and Pain Medicine, University Hospitals Leuven, Leuven, Belgium.

Department of Anaesthesiology and Pain Medicine, Jessa Hospital, Hasselt, Belgium; Pain Clinic, Department of Anaesthesiology and Perioperative Medicine, Vrije Universiteit Brussel (VUB), University Hospital Brussels (UZ Brussel), Brussels, Belgium.

出版信息

J Clin Anesth. 2021 Oct;73:110329. doi: 10.1016/j.jclinane.2021.110329. Epub 2021 May 5.

DOI:10.1016/j.jclinane.2021.110329

PMID:33962340

Abstract

STUDY OBJECTIVE

This study aimed to assess if a forearm (FA) intravenous regional anesthesia (IVRA) with a lower, less toxic, local anesthetic dosage is non-inferior to an upper arm (UA) IVRA in providing a surgical block in patients undergoing hand and wrist surgery.

DESIGN

Observer-blinded, randomized non-inferiority study.

SETTING

Operating room.

PATIENTS

280 patients undergoing hand surgery were randomly assigned to UA IVRA (n = 140) or FA IVRA (n = 140).

INTERVENTIONS

Forearm IVRA or upper arm IVRA in patients undergoing hand and wrist surgery.

MEASUREMENTS

The primary outcome was block success rate of both techniques. Block success was defined as no need of additional analgesics. A second, alternative non-inferiority outcome was defined as no need of conversion to general anesthesia. A difference in success rate of <5% was considered non-inferior. Secondary endpoints were tourniquet pain measured with a Numerical Rating Scale (0-10), satisfaction of patients and surgeons, onset time, surgical time and total OR time.

MAIN RESULTS

Non-inferiority of block success rate, defined as no need of additional analgesics or conversion to general anesthesia was inconclusive (5.24%, 95% CI:-4.34%,+14.82%). Non-inferiority of no need of conversion to general anesthesia was confirmed (+0.73%, 95% CI:-0.69%,+2.15%). No differences were observed in onset time (FA: 5 (5, 8) vs UA: 6 (5, 7) min, p = 0.74), surgical time (FA: 8 (5, 12) vs UA: 7 (5, 11) min, p = 0.71), nor total OR stay time (FA: 34 (27, 41) vs UA: 35 (32, 39) min, p = 0.09). Tourniquet pain after 10 min was significantly lower after FA IVRA compared to UA IVRA (FA: 2.00 (0.00, 4.00) vs UA: 3.00 (1.00,5.00) min, p = 0.003).

CONCLUSION

We failed to demonstrate non-inferiority of forearm IVRA with a lower dosage of LA in providing a surgical block without rescue opioids and LA. Non-inferiority of no need of conversion to general anesthesia was confirmed.

摘要

研究目的

本研究旨在评估在手部和腕部手术中，与使用较少、毒性较低的局部麻醉剂的上臂（UA）区域静脉麻醉（IVRA）相比，使用较低剂量的前臂（FA）IVRA 是否能提供同等的手术阻滞效果。

设计

观察者设盲、随机非劣效性研究。

地点

手术室。

患者

280 名接受手部手术的患者被随机分配至 UA-IVRA（n=140）或 FA-IVRA（n=140）。

干预措施

FA-IVRA 或 UA-IVRA 用于接受手部和腕部手术的患者。

测量

主要结局是两种技术的阻滞成功率。阻滞成功定义为无需额外使用镇痛药。第二个替代非劣效性结局定义为无需转换为全身麻醉。成功率差异<5%被认为是非劣效的。次要终点是使用数字评分量表（0-10）测量的止血带疼痛、患者和外科医生的满意度、起效时间、手术时间和总手术时间。

主要结果

阻滞成功率的非劣效性，定义为无需额外使用镇痛药或转换为全身麻醉的结论不确定（5.24%，95%CI：-4.34%，+14.82%）。无需转换为全身麻醉的非劣效性得到证实（+0.73%，95%CI：-0.69%，+2.15%）。FA 的起效时间（5（5，8）vs UA：6（5，7）min，p=0.74）、手术时间（FA：8（5，12）vs UA：7（5，11）min，p=0.71）和总手术时间（FA：34（27，41）vs UA：35（32，39）min，p=0.09）均无差异。FA-IVRA 后 10 分钟的止血带疼痛明显低于 UA-IVRA（FA：2.00（0.00，4.00）vs UA：3.00（1.00，5.00）min，p=0.003）。