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鞘内注射吗啡在低剂量罗哌卡因下经皮内窥镜腰椎间盘切除术的有效性和安全性:一项前瞻性、随机、双盲临床试验。

Effectiveness and safety of intrathecal morphine for percutaneous endoscopic lumbar discectomy under low-dose ropivacaine: a prospective, randomized, double-blind clinical trial.

机构信息

Department of Orthopedics, Peking University First Hospital, 8th Xishuku Ave, Xicheng District, Beijing, 100034, China.

Department of Anesthesiology, Peking University First Hospital, 8th Xishuku Ave, Xicheng District, Beijing, 100034, China.

出版信息

Spine J. 2023 Jul;23(7):954-961. doi: 10.1016/j.spinee.2023.03.001. Epub 2023 Mar 15.

Abstract

BACKGROUND CONTEXT

Percutaneous endoscopic lumbar discectomy (PELD) is a surgical setting that requires minimal motor impairment. Low-dose spinal ropivacaine induces little motor blockade and could be ideal for maintaining safety of PELD, but its analgesic efficacy is questionable. An adjunct analgesic approach is needed to maximize the benefits of low-dose spinal ropivacaine for PELD.

PURPOSE

This study aimed to explore the effectiveness and safety of 100 µg intrathecal morphine (ITM) as an adjuvant analgesic method for PELD under low-dose spinal ropivacaine.

STUDY DESIGN

A double-blind, randomized, placebo-controlled trial.

TRIAL REGISTRATION

ChiCTR2000039842 (www.chictr.org.cn).

SAMPLE

Ninety patients scheduled for elective single-level PELD under low-dose spinal ropivacaine.

OUTCOME MEASURES

The primary outcome was the overall intraoperative visual analogue scale (VAS) score for pain. Secondary outcomes were intraoperative VAS scores assessed at multiple timepoints; intraoperative rescue analgesic requirement; postoperative VAS scores; disability scale; patients' satisfaction with anesthesia; adverse events; and radiographic outcomes.

METHODS

Patients were randomized to receive low-dose ropivacaine spinal anesthesia with (ITM group, n=45) or without (control group, n=45) 100 µg ITM.

RESULTS

The overall intraoperative VAS score in the ITM group was significantly lower than that in the control group (0 [0, 1] vs 2 [1, 3], p<.001). During operation, the VAS scores at cannula insertion, 30 minutes after insertion, 60 minutes after insertion, and 120 minutes after insertion were all significantly lower in the ITM group (all p<.05). Less patients in the ITM group required rescue analgesia during operation compared with those in the control group (14% vs 42%, p= .003). The VAS score for back pain in the ITM group was lower than that in the control group at 1 hour, 12 hours, and 24 hours postoperatively. Besides, the satisfaction score in the ITM group was significantly higher than that in the control group (p=.017). For adverse events, 8/43 of ITM and 1/44 of control participants experienced pruritus (p=.014), with a relative risk (95% confidence interval) of 8.37 (1.09-64.16). The incidence of other adverse events was similar between the two groups. Of note, respiratory depression occurred in one ITM-treated patient.

CONCLUSION

The addition of 100 µg ITM to low-dose ropivacaine appears to be effective in analgesia without compromised motor function for PELD; however, ITM increased the risk of pruritus and clinicians should be vigilant about its potential risk of respiratory depression.

摘要

背景

经皮内镜腰椎间盘切除术(PELD)是一种需要最小运动障碍的手术环境。小剂量罗哌卡因脊髓麻醉诱导的运动阻滞较小,可能是维持 PELD 安全性的理想选择,但它的镇痛效果仍存在争议。需要一种辅助镇痛方法来最大限度地提高小剂量罗哌卡因脊髓麻醉在 PELD 中的益处。

目的

本研究旨在探讨鞘内注射 100μg 吗啡(ITM)作为小剂量罗哌卡因脊髓麻醉下 PELD 的辅助镇痛方法的有效性和安全性。

研究设计

双盲、随机、安慰剂对照试验。

试验注册

ChiCTR2000039842(www.chictr.org.cn)。

样本

90 例拟行小剂量罗哌卡因脊髓麻醉下择期单节段 PELD 的患者。

结局测量

主要结局为术中总体视觉模拟评分(VAS)疼痛评分。次要结局为多个时间点的术中 VAS 评分;术中需要解救性镇痛的需求;术后 VAS 评分;残疾量表;患者对麻醉的满意度;不良反应;和影像学结果。

方法

患者随机分为接受小剂量罗哌卡因脊髓麻醉加(ITM 组,n=45)或不加(对照组,n=45)100μg ITM。

结果

ITM 组的总体术中 VAS 评分明显低于对照组(0[0,1]比 2[1,3],p<.001)。在手术过程中,插入套管时、插入后 30 分钟、60 分钟和 120 分钟时的 VAS 评分在 ITM 组均显著降低(均 p<.05)。与对照组相比,ITM 组术中需要解救性镇痛的患者更少(14%比 42%,p=.003)。术后 1 小时、12 小时和 24 小时,ITM 组的腰痛 VAS 评分均低于对照组。此外,ITM 组的满意度评分明显高于对照组(p=.017)。对于不良反应,43 例 ITM 组和 44 例对照组中有 8 例出现瘙痒(p=.014),相对风险(95%置信区间)为 8.37(1.09-64.16)。两组的其他不良反应发生率相似。值得注意的是,1 例 ITM 治疗患者发生呼吸抑制。

结论

小剂量罗哌卡因脊髓麻醉加用 100μg ITM 似乎在不影响运动功能的情况下对 PELD 具有良好的镇痛效果,但 ITM 增加了瘙痒的风险,临床医生应警惕其呼吸抑制的潜在风险。

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