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EASIER 试验(急诊室中脊柱旁肌平面镇痛用于治疗肝胆胰疼痛):一项单中心、开放标签、基于队列的随机对照试验,分析了超声引导下竖脊肌平面阻滞与静脉注射吗啡治疗急诊科急性肝胆胰疼痛的疗效。

EASIER trial (Erector-spinAe analgeSia for hepatopancreaticobiliary pain In the Emergency Room): a single-centre open-label cohort-based randomised controlled trial analysing the efficacy of the ultrasound-guided erector-spinae plane block compared with intravenous morphine in the treatment of acute hepatopancreaticobiliary pain in the emergency department.

机构信息

Department of Emergency Medicine, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India

Department of Emergency Medicine, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India.

出版信息

Emerg Med J. 2024 Sep 25;41(10):588-594. doi: 10.1136/emermed-2023-213799.

Abstract

BACKGROUND

Ultrasound-guided (USG) erector-spinae plane block (ESPB) may be better than intravenous opioids in treating acute hepatopancreaticobiliary (HPB) pain in the ED.

METHODS

This open-label randomised controlled trial was conducted in the ED of a tertiary-care hospital between March and August 2023. All adult patients with severe HPB pain were recruited during times that a primary investigator was present. Unconsenting patients, numeric rating scale (NRS) ≤6, age ≤18 and ≥80 years, pregnant, unstable or with allergies to local anaesthetics or opioids were excluded. Patients in the intervention arm received bilateral USG ESPB with 0.2% ropivacaine at T7 level, by a trained ED consultant, and those in the control arm received 0.1 mg/kg intravenous morphine. Pain on a 10-point NRS was assessed by the investigators at presentation and at 1, 3, 5 and 10 hours after intervention by the treatment team, along with rescue analgesia requirements and patient satisfaction. Difference in NRS was analysed using analysis of co-variance (ANCOVA) and t-tests.

RESULTS

70 participants were enrolled, 35 in each arm. Mean age was 40.4±13.2 years, mean NRS at presentation in the intervention arm was 8.0±0.9 and 7.6±0.6 in the control arm. NRS at 1 hour was significantly lower in the ESPB group (ANCOVA p<0.001). At 1, 3, 5 and 10 hours, reduction of NRS in the intervention arm (7±1.6, 6.7±1.9, 6.6±1.8, 6.1±1.9) was significantly greater than the control arm (4.4±2, 4.6±1.8, 3.7±2.2, 3.8±1.8) (t-test, p<0.001). Fewer patients receiving ESPB required rescue analgesia at 5 (t-test, p=0.031) and 10 hours (t-test, p=0.04). More patients were 'very satisfied' with ESPB compared with receiving only morphine at each time period (p<0.001).

CONCLUSION

ESPB is a promising alternative to morphine in those with HPB pain.

TRIAL REGISTRATION NUMBER

CTRI/2023/03/050595.

摘要

背景

超声引导竖脊肌平面阻滞(ESPB)在治疗急诊肝胆胰疾病(HPB)疼痛方面可能优于静脉内阿片类药物。

方法

本开放标签随机对照试验于 2023 年 3 月至 8 月在一家三级保健医院的急诊室进行。所有患有严重 HPB 疼痛的成年患者均在主要调查员在场时招募。不合作的患者、数字评分量表(NRS)≤6、年龄≤18 岁和≥80 岁、孕妇、不稳定或对局部麻醉剂或阿片类药物过敏者被排除在外。干预组患者接受由经过培训的急诊顾问在 T7 水平进行双侧超声引导 ESPB,用 0.2%罗哌卡因,而对照组患者接受 0.1mg/kg 静脉内吗啡。由调查员在就诊时和治疗团队在干预后 1、3、5 和 10 小时评估 NRS 疼痛,同时评估镇痛补救需求和患者满意度。使用协方差分析(ANCOVA)和 t 检验分析 NRS 差异。

结果

70 名参与者被纳入,每组 35 名。平均年龄为 40.4±13.2 岁,干预组的平均 NRS 在就诊时为 8.0±0.9,对照组为 7.6±0.6。ESP 组在 1 小时时的 NRS 显著较低(ANCOVA p<0.001)。在 1、3、5 和 10 小时时,干预组的 NRS 降低(7±1.6、6.7±1.9、6.6±1.8、6.1±1.9)明显大于对照组(4.4±2、4.6±1.8、3.7±2.2、3.8±1.8)(t 检验,p<0.001)。接受 ESPB 的患者在 5(t 检验,p=0.031)和 10 小时(t 检验,p=0.04)时需要镇痛补救的患者较少。与仅接受吗啡相比,每个时间点接受 ESPB 的患者“非常满意”的比例更高(p<0.001)。

结论

ESPB 是治疗 HPB 疼痛的一种有前途的吗啡替代方法。

试验注册号

CTRI/2023/03/050595。

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