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Analgesia for major laparoscopic abdominal surgery: a randomised feasibility trial using intrathecal morphine
Anaesthesia ( IF 7.5 ) Pub Date : 2022-01-17 , DOI: 10.1111/anae.15651
K Pirie 1 , M A Doane 1 , B Riedel 2 , P S Myles 3
Affiliation  

Effective pain control enhances patient recovery after surgery. Laparoscopic techniques for major abdominal surgery are increasingly utilised to reduce surgical trauma. Intrathecal morphine is an attractive analgesic option that is gaining popularity. However, limited evidence guides its use in the setting of laparoscopic surgery. In addition, enhanced recovery after surgery pathways advocate opioid-sparing techniques. We conducted a feasibility trial to compare intrathecal morphine with non-neuraxial analgesia in laparoscopic or laparoscopic-assisted major abdominal surgery to inform the design of a future large clinical trial. This multicentre, double-blind, randomised controlled trial was conducted at two tertiary hospitals in Australia. Fifty-one patients were randomly allocated to receive either intrathecal morphine (intervention group) or a sham subcutaneous injection of normal saline in the lumbar area (control group) immediately before the induction of general anaesthesia. Co-primary outcomes were patient recruitment and successful adherence to treatment allocation as per the study protocol. The primary endpoints of feasibility and protocol adherence were met with a 46% recruitment rate (51 of 110 eligible patients) and 96% protocol adherence. There was only one patient with failed access to the intrathecal space. For secondary endpoints, fewer patients in the intrathecal morphine group required opioids in the post-anaesthesia care unit, their postoperative pain scores at rest were lower across the four time-points measured (p = 0.007), but not dynamic pain scores (p = 0.061), and pruritus was more common following intrathecal morphine (p = 0.007). Total oral morphine equivalents until postoperative day 3 were less in the intrathecal morphine group (median (95%CI) difference 82 (−13 to 168) mg), but this reduction was not statistically significant (p = 0.10). These findings support conducting a definitive clinical trial.

中文翻译:

腹腔镜腹部大手术的镇痛:鞘内注射吗啡的随机可行性试验

有效的疼痛控制可促进患者术后恢复。用于腹部大手术的腹腔镜技术越来越多地用于减少手术创伤。鞘内注射吗啡是一种有吸引力的镇痛选择,越来越受欢迎。然而,有限的证据指导其在腹腔镜手术中的应用。此外,促进术后恢复的途径提倡阿片类药物保留技术。我们进行了一项可行性试验,以比较鞘内吗啡与非椎管内镇痛在腹腔镜或腹腔镜辅助腹部大手术中的应用,为未来大型临床试验的设计提供信息。这项多中心、双盲、随机对照试验在澳大利亚的两家三级医院进行。51 名患者被随机分配接受鞘内吗啡(干预组)或在全身麻醉诱导前立即在腰椎区域(对照组)进行生理盐水假皮下注射。共同主要结果是患者招募和根据研究方案成功遵守治疗分配。可行性和方案依从性的主要终点达到了 46% 的招募率(110 名符合条件的患者中的 51 名)和 96% 的方案依从性。只有一名患者无法进入鞘内空间。对于次要终点,鞘内吗啡组在麻醉后护理单元中需要阿片类药物的患者较少,在四个测量的时间点,他们的术后静息疼痛评分较低(p = 0.007),但动态疼痛评分不低于(p = 0。061),鞘内注射吗啡后瘙痒更常见(p = 0.007)。鞘内注射吗啡组直至术后第 3 天的总口服吗啡当量较少(中位数 (95%CI) 差异为 82 (-13 至 168) mg),但这种减少没有统计学意义(p = 0.10)。这些发现支持进行明确的临床试验。
更新日期:2022-01-17
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