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随机对照临床试验:脂质体布比卡因腹横肌平面阻滞与椎管内镇痛用于结直肠手术。

Randomized clinical trial of liposomal bupivacaine transverse abdominis plane block versus intrathecal analgesia in colorectal surgery.

机构信息

Department of Colon and Rectal Surgery, Mayo Clinic, Jacksonville, Florida, USA.

Division of Biomedical Statistics and Informatics, Mayo Clinic, Jacksonville, Florida, USA.

出版信息

Br J Surg. 2019 May;106(6):692-699. doi: 10.1002/bjs.11141. Epub 2019 Mar 28.

Abstract

BACKGROUND

Transverse abdominis plane (TAP) block is considered an effective alternative to neuraxial analgesia for abdominal surgery. However, limited evidence supports its use over traditional analgesic modalities in colorectal surgery. This study compared the analgesic efficacy of liposomal bupivacaine TAP block with intrathecal (IT) opioid administration in a multicentre RCT.

METHODS

Patients undergoing elective small bowel or colorectal resection were randomized to receive TAP block or a single injection of IT analgesia with hydromorphone. Patients were assessed at 4, 8, 16, 24 and 48 h after surgery. Primary outcomes were mean pain scores and morphine milligram equivalents (MMEs) administered within 48 h after surgery. Secondary outcomes included duration of hospital stay, incidence of postoperative ileus and use of intravenous patient-controlled analgesia.

RESULTS

In total, 209 patients were recruited and 200 completed the trial (TAP 102, IT 98). The TAP group had a 1·6-point greater mean pain score than the IT group at 4 h after surgery, and this difference lasted for 16 h after operation. The TAP group received more MMEs within the first 24 h after surgery than the IT group (median difference in MMEs 10·0, 95 per cent c.i. 3·0 to 20·5). There were no differences in MME use at 24 and 48 h, or with respect to secondary outcomes.

CONCLUSION

IT opioid administration provided better immediate postoperative pain control than TAP block. Both modalities resulted in low pain scores in patients undergoing elective colorectal surgery and should be considered in multimodal postoperative analgesic plans. Registration number: NCT02356198 ( http://www.clinicaltrials.gov).

摘要

背景

腹横肌平面(TAP)阻滞被认为是腹部手术中替代椎管内镇痛的有效方法。然而,有限的证据支持其在结直肠手术中优于传统镇痛方式。本研究在一项多中心 RCT 中比较了脂质体布比卡因 TAP 阻滞与鞘内(IT)阿片类药物给药在镇痛效果上的差异。

方法

择期行小肠或结直肠切除术的患者被随机分为 TAP 阻滞组或单次 IT 镇痛组(氢吗啡酮)。患者在术后 4、8、16、24 和 48 小时进行评估。主要结局为术后 48 小时内平均疼痛评分和吗啡毫克当量(MME)。次要结局包括住院时间、术后肠梗阻发生率和静脉自控镇痛(IVPCA)的使用。

结果

共纳入 209 例患者,200 例完成试验(TAP 组 102 例,IT 组 98 例)。TAP 组术后 4 小时的平均疼痛评分比 IT 组高 1.6 分,且这种差异持续 16 小时。TAP 组在术后 24 小时内接受的 MME 比 IT 组多(MME 差值中位数为 10.0,95%置信区间为 3.0 至 20.5)。在术后 24 小时和 48 小时时,以及在次要结局方面,两组间均无差异。

结论

IT 阿片类药物给药比 TAP 阻滞提供了更好的即刻术后疼痛控制。两种方法均使接受择期结直肠手术的患者疼痛评分较低,应在多模式术后镇痛方案中考虑。注册号:NCT02356198(http://www.clinicaltrials.gov)。

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