Grace Centre for Newborn Intensive Care, The Children's Hospital at Westmead, Sydney, New South Wales, Australia
Discipline of Child and Adolescent Health, The Children's Hospital at Westmead Clinical School, Sydney Medical School, Sydney, New South Wales, Australia.
BMJ Paediatr Open. 2022 Aug;6(1). doi: 10.1136/bmjpo-2022-001586.
To determine the effect of continuous wound infusion of local anaesthetic drug (bupivacaine) on total amount of systemic opioid use in the first 72 hours in newborn infants undergoing laparotomy.
A two-arm parallel, open-label randomised controlled trial.
A quaternary newborn intensive care unit.
Infants37 weeks of gestation undergoing laparotomy for congenital or acquired abdominal conditions.
Continuous wound infusion of local anaesthetic (bupivacaine) for the first 72 hours along with systemic opioid analgesia (catheter group) or only systemic opioid analgesia (opioid group).
Total amount of systemic opioid used within the first 72 hours post laparotomy.
The study was underpowered as only 30 of the expected sample size of 70 infants were enrolled. 16 were randomised to catheter group and 14 to opioid group. The two groups were similar at baseline. There was no significant difference between the groups for the primary outcome of median total systemic opioid use in the first 72 hours post laparotomy (catheter 431.5 µg/kg vs opioid 771 µg/kg, difference -339.5 µg/kg, 90% CI 109, p value 0.28). There was no significant difference between the groups for any of the secondary outcomes including pain scores, duration of mechanical ventilation, time to reach full feeds and duration of hospital stay. There were no adverse events noted.
Continuous wound infusion of local anaesthetic along with systemic opioid analgesia is feasible. The lack of a difference in total systemic opioid use in the first 72 hours cannot be reliably interpreted as the study was underpowered.
ACTRN12610000633088.
确定在接受剖腹手术的新生儿中，连续伤口输注局部麻醉药物（布比卡因）对术后 72 小时内全身阿片类药物总用量的影响。
双臂平行、开放标签随机对照试验。
一家四级新生儿重症监护病房。
胎龄 37 周、因先天性或后天性腹部疾病而行剖腹手术的婴儿。
在术后 72 小时内连续伤口输注局部麻醉剂（布比卡因），同时给予全身阿片类药物镇痛（导管组）或仅给予全身阿片类药物镇痛（阿片类药物组）。
剖腹手术后 72 小时内使用的全身阿片类药物总量。
由于预计 70 名婴儿中只有 30 名入组，因此该研究的效力不足。16 名婴儿被随机分配到导管组，14 名婴儿被分配到阿片类药物组。两组在基线时相似。两组在术后 72 小时内的主要结局（即剖腹手术后 72 小时内使用的全身阿片类药物中位数）方面无显著差异（导管组为 431.5µg/kg，阿片类药物组为 771µg/kg，差异为-339.5µg/kg，90%置信区间为 109，p 值为 0.28）。在次要结局（包括疼痛评分、机械通气时间、达到全肠喂养时间和住院时间）方面，两组之间也没有显著差异。未观察到不良事件。
连续伤口输注局部麻醉剂联合全身阿片类药物镇痛是可行的。在术后 72 小时内，全身阿片类药物总用量无差异的结果不能被可靠地解释为研究效力不足。
ACTRN12610000633088。
