Ultrasound-guided transmuscular quadratus lumborum catheters for elective caesarean section: A protocol for a single-centre, double-blind randomised trial
Ultrasound-guided transmuscular quadratus lumborum catheters for elective caesarean section: A protocol for a single-centre, double-blind randomised trial
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DOI：
10.1111/aas.13601
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发表时间：
2020-04-22
影响因子：
2.1
通讯作者：
Borglum, Jens
中科院分区：
文献类型：
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作者：
Steingrimsdottir, Guony E.;Hansen, Christian K.;Borglum, Jens
背景选择性剖腹产（ECS）术后中度至重度疼痛的管理在国际上主要基于硬膜外导管或阿片类药物。然而，这两种技术都与一些不良事件相关。已证明双侧经肌腰方肌（TQL）阻滞可显著减少ECS术后前24小时内阿片类药物的消耗，并延长至首次使用阿片类药物（TFO）的时间（汉森CKD，Steingrimsdottir M，Laier GE，et al. Reg Anesth Pain Med. 2019; 10.1136/rapm-2019-100540）。我们提出了一个随机对照试验，旨在调查是否通过双边TQL导管持续镇痛可以延长TFO后ECS.Methods这项研究是一个双盲，随机，安慰剂对照试验。患者应年满18岁，并计划在脊髓麻醉下进行ECS。主要排除标准是无法合作，每日过量摄入阿片类药物以及肌肉和筋膜结构的超声可视化困难。参与者随机接受超声引导下双侧注射30 mL 0.2%罗哌卡因和含0.2%罗哌卡因的弹性泵，或双侧注射30 mL生理盐水和含生理盐水的弹性泵，导管放置后2小时。主要终点是TFO。次要结局包括数字评分量表（NRS）上的疼痛强度、24小时内累积吗啡消耗量、导管移位频率和吗啡相关不良事件。招募期2018年9月至2018年11月纳入4例患者。2019年6月恢复入组，并将持续至24例具有有用数据的患者入组试验。预期入选期为10-14个月。试验注册ClinicalTrials.gov标识符：NCT 03663478.EudraCT：2017-003625-15。
Background Management of moderate-to-severe post-operative pain after elective caesarean section (ECS) is internationally primarily based on either epidural catheters or opioids. However, both techniques are associated with some undesirable adverse events. Bilateral transmuscular quadratus lumborum (TQL) block has proven to reduce opioid consumption significantly in the first 24 post-operative hours following ECS and prolong time to first opioid (TFO) (Hansen CKD, Steingrimsdottir M, Laier GE, et al. Reg Anesth Pain Med. 2019; 10.1136/rapm-2019-100540). We present a randomised controlled trial aiming to investigate whether continuous analgesia via bilateral TQL catheters can prolong TFO after ECS.Methods This study is a double-blind, randomised, placebo-controlled trial. Patients should be 18 years or older and scheduled for ECS under spinal anaesthesia to be included. Main exclusion criteria are inability to cooperate, excessive daily intake of opioids and difficult ultrasound visualisation of muscular and fascial structures. Participants are randomised to receive ultrasound-guided injection of either 30 mL ropivacaine 0.2% bilaterally and an elastomeric pump containing 0.2% ropivacaine, or 30 mL saline bilaterally and an elastomeric pump containing saline, 2 hours after catheter placement. The primary endpoint is TFO. Secondary outcomes include pain intensity on a numeric rating scale (NRS), accumulated morphine consumption during 24 hours, displacement frequency of catheters and morphine-related adverse events.Recruitment period Four patients were included from September 2018 to November 2018. Inclusion was resumed in June 2019 and will continue until 24 patients with useful data have been included in the trial. Expected inclusion period is 10-14 months.Trial registration ClinicalTrials.gov identifier: NCT03663478.EudraCT: 2017-003625-15.