BJS open · 2025
Scheduled intravenous acetaminophen versus thoracic epidural analgesia for postoperative pain control after minimally invasive gastrectomy: multicentre randomized non-inferiority trial.
Equivalence TrialСтатьяМногоцентровое исследованиеPragmatic Clinical TrialРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Kinoshita Jun, Hayashi Saki, Tsuji Toshikatsu, Moriyama Hideki, Yamazaki Yuki, Kitano Yuto, Tsukada Tomoya, Kaji Masahide, Yamaguchi Takahisa, Kadoya Shinichi, Yagi Yasumichi, Shimada Masanari, Soga Shingo, Fushida Sachio, Taniguchi Takumi, Inaki Noriyuki
Аннотация
BACKGROUND: Thoracic epidural analgesia (TEA) is widely used for postoperative pain control in abdominal surgery, but its role in minimally invasive procedures remains unclear. This pragmatic multicentre open-label randomized non-inferiority trial evaluated whether scheduled intravenous acetaminophen combined with local wound infiltration provides non-inferior analgesia to TEA following minimally invasive gastrectomy.
METHODS: Adults with gastric adenocarcinoma categorized as clinical stage I-III (according to the Japanese classification of gastric carcinoma) who were undergoing laparoscopic or robot-assisted gastrectomy were randomized 1 : 1 to TEA or scheduled intravenous acetaminophen (1 g every 6 hours (h) for 72 h). All patients received wound infiltration with ropivacaine. Participants and clinicians were not blinded to the randomization; statisticians were masked. The primary endpoint in the study was the proportion of patients with a numerical rating scale (NRS) pain score ≥ 4 at rest 24 h after surgery, with a prespecified non-inferiority margin of 20 percentage points. Analyses used the modified intention-to-treat population.
RESULTS: Between June 2020 and May 2024, 140 patients were randomized and 135 were analysed (TEA 68, acetaminophen 67). At 24 h after surgery, 27.9% of patients in the TEA group and 23.9% in the acetaminophen group had an NRS score ≥ 4 at rest (risk difference -4.1%; 95% confidence interval -24.3 to 16.6), confirming non-inferiority. Pain trajectories, rescue analgesic use, patient satisfaction, and recovery were comparable between the two groups. No patient required rescue opioids, and there were no serious catheter- or acetaminophen-related adverse events.
CONCLUSION: Scheduled intravenous acetaminophen with wound infiltration was non-inferior to TEA for postoperative pain after minimally invasive gastrectomy and provided safe, effective, and opioid-sparing analgesia consistent with enhanced recovery principles. Registration number: UMIN000039505 (https://www.umin.ac.jp/english/).
METHODS: Adults with gastric adenocarcinoma categorized as clinical stage I-III (according to the Japanese classification of gastric carcinoma) who were undergoing laparoscopic or robot-assisted gastrectomy were randomized 1 : 1 to TEA or scheduled intravenous acetaminophen (1 g every 6 hours (h) for 72 h). All patients received wound infiltration with ropivacaine. Participants and clinicians were not blinded to the randomization; statisticians were masked. The primary endpoint in the study was the proportion of patients with a numerical rating scale (NRS) pain score ≥ 4 at rest 24 h after surgery, with a prespecified non-inferiority margin of 20 percentage points. Analyses used the modified intention-to-treat population.
RESULTS: Between June 2020 and May 2024, 140 patients were randomized and 135 were analysed (TEA 68, acetaminophen 67). At 24 h after surgery, 27.9% of patients in the TEA group and 23.9% in the acetaminophen group had an NRS score ≥ 4 at rest (risk difference -4.1%; 95% confidence interval -24.3 to 16.6), confirming non-inferiority. Pain trajectories, rescue analgesic use, patient satisfaction, and recovery were comparable between the two groups. No patient required rescue opioids, and there were no serious catheter- or acetaminophen-related adverse events.
CONCLUSION: Scheduled intravenous acetaminophen with wound infiltration was non-inferior to TEA for postoperative pain after minimally invasive gastrectomy and provided safe, effective, and opioid-sparing analgesia consistent with enhanced recovery principles. Registration number: UMIN000039505 (https://www.umin.ac.jp/english/).