A randomized, noninferiority clinical trial of Single-Shot Intrathecal Morphine versus Continuous Wound Infiltration for postoperative pain control after open pancreatoduodenectomy.
Intrathecal morphine (ITM) and continuous wound infiltration (CWI) are two alternatives to thoracic epidural analgesia in major abdominal surgery, but direct comparative studies are lacking. We evaluated whether ITM is noninferior to CWI after open pancreatoduodenectomy.
An open-label, randomised, noninferiority clinical trial conducted at a tertiary hospital. Adult patients undergoing elective open pancreatoduodenectomy were randomised 1:1 to receive either a single-shot ITM (0.2 mg) or bilateral preperitoneal CWI. Both groups received standardised multimodal and intravenous patient-controlled analgesia (IV-PCA). The primary outcome was the mean coughing pain score, averaged across 24, 48, and 72 h postoperatively, analysed for noninferiority using the 95% confidence interval (noninferiority margin: 1.0). Secondary outcomes included the mean resting pain score, pain score at each time point (2, 24, 48, and 72 h), IV-PCA fentanyl consumption, EuroQol 5-Dimension 5-Level utility score, and postoperative complications.
In the per-protocol population (n = 92), ITM was noninferior to CWI for the primary outcome (ITM: 5.7 ± 1.7 vs. CWI: 6.1 ± 1.5; mean difference -0.5, 95% confidence interval -1.1 to 0.2). ITM was also noninferior to CWI regarding the mean resting pain score. ITM provided significantly lower pain scores at 2 h postoperatively, both at rest and on coughing, with a sustained reduction on coughing at 24 h and reduced fentanyl consumption. Otherwise comparable, ITM increased respiratory depression and pruritus within 24 h.
ITM provides noninferior overall and superior early analgesia to CWI after open pancreatoduodenectomy, although careful monitoring for early side effects is warranted.
ClinicalTrials.gov Identifier (No. NCT06761989, https://clinicaltrials.gov/study/NCT06761989) registered on 30 December 2024.
An open-label, randomised, noninferiority clinical trial conducted at a tertiary hospital. Adult patients undergoing elective open pancreatoduodenectomy were randomised 1:1 to receive either a single-shot ITM (0.2 mg) or bilateral preperitoneal CWI. Both groups received standardised multimodal and intravenous patient-controlled analgesia (IV-PCA). The primary outcome was the mean coughing pain score, averaged across 24, 48, and 72 h postoperatively, analysed for noninferiority using the 95% confidence interval (noninferiority margin: 1.0). Secondary outcomes included the mean resting pain score, pain score at each time point (2, 24, 48, and 72 h), IV-PCA fentanyl consumption, EuroQol 5-Dimension 5-Level utility score, and postoperative complications.
In the per-protocol population (n = 92), ITM was noninferior to CWI for the primary outcome (ITM: 5.7 ± 1.7 vs. CWI: 6.1 ± 1.5; mean difference -0.5, 95% confidence interval -1.1 to 0.2). ITM was also noninferior to CWI regarding the mean resting pain score. ITM provided significantly lower pain scores at 2 h postoperatively, both at rest and on coughing, with a sustained reduction on coughing at 24 h and reduced fentanyl consumption. Otherwise comparable, ITM increased respiratory depression and pruritus within 24 h.
ITM provides noninferior overall and superior early analgesia to CWI after open pancreatoduodenectomy, although careful monitoring for early side effects is warranted.
ClinicalTrials.gov Identifier (No. NCT06761989, https://clinicaltrials.gov/study/NCT06761989) registered on 30 December 2024.
Authors
Yoon Yoon, Kim Kim, Lee Lee, Park Park, Jung Jung, Cho Cho, Kwon Kwon, Park Park, Jung Jung, Jang Jang
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