Pirie Katrina, Traer Emily, Winter Noam, Brown Wendy, Riedel Bernhard, Myles Paul S
Department of Anaesthesiology and Perioperative Medicine, The Alfred Hospital, Melbourne, VIC, Australia.
Department of Anaesthesiology and Perioperative Medicine, School of Translational Medicine, Monash University, Melbourne, VIC, Australia.
BJA Open. 2025 Mar 20;14:100386. doi: 10.1016/j.bjao.2025.100386. eCollection 2025 Jun.
Evidence to support the effectiveness of intrathecal morphine in patients undergoing minimally invasive abdominal surgery is largely based on small, single-centre studies. We therefore designed a large, multi-centre clinical trial to investigate the effect of intrathecal morphine with local anaesthetic on patient postoperative quality of recovery. The primary objective is to compare quality of recovery on postoperative Day 1. The secondary objectives are to compare opioid consumption, pain scores, and opioid-related adverse events.
This multi-centre, prospective, randomised controlled trial will recruit 280 adult patients undergoing minimally invasive major abdominal surgery. The intervention group will receive 200 mcg of intrathecal morphine with local anaesthetic, as part of a multimodal analgesic strategy. Following safety analysis after the first 100 patients the dose of ITM will increase to 300 mcg. The control group will receive non-neuraxial multimodal analgesia.
This trial is expected to provide evidence on the effectiveness and the safety of two different ITM doses with local anaesthetic in major minimally invasive abdominal surgery.
ACTRN12623001347651 (ANZCTR Registry Number).
1.0, May 2, 2024.
支持鞘内注射吗啡对接受微创腹部手术患者有效性的证据主要基于小型单中心研究。因此，我们设计了一项大型多中心临床试验，以研究鞘内注射吗啡联合局部麻醉剂对患者术后恢复质量的影响。主要目的是比较术后第1天的恢复质量。次要目的是比较阿片类药物消耗量、疼痛评分和阿片类药物相关不良事件。
这项多中心、前瞻性、随机对照试验将招募280名接受微创大型腹部手术的成年患者。干预组将接受200微克鞘内注射吗啡联合局部麻醉剂，作为多模式镇痛策略的一部分。在前100名患者进行安全性分析后，鞘内吗啡剂量将增加至300微克。对照组将接受非神经轴多模式镇痛。
本试验有望为两种不同剂量鞘内吗啡联合局部麻醉剂在大型微创腹部手术中的有效性和安全性提供证据。
ACTRN12623001347651（澳大利亚和新西兰临床试验注册中心注册号）。
1.0，2024年5月2日。
