Drug design, development and therapy · 2026
Determination of the ED90 for Epidural Hydromorphone and Morphine for Postoperative Pain Using a Biased-Coin Up-and-Down Sequential Design After Elective Cesarean Delivery.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Tang Xiaolin, Liang Yu, Hu Yuting, Li Peng, Wang Jiani, Wang Yujue, Xie Min
Аннотация
BACKGROUND: Hydromorphone and morphine are the primary opioids recommended for epidural analgesia following cesarean delivery. This study aimed to determine the 90% effective dose (ED90) of epidural hydromorphone and morphine in this patient population.
METHODS: In this dose-finding trial, 80 patients undergoing cesarean delivery under combined spinal-epidural anesthesia (CSEA) were randomized to receive a single epidural injection of either hydromorphone or morphine after uterine closure. The dose of each agent was determined using a biased-coin up-and-down sequential allocation method to estimate the ED90. In addition, all patients received standardized multimodal analgesia postoperatively. Satisfactory analgesia was defined as a visual analogue scale (VAS) score ≤3 within 12 hours after cesarean delivery, without the need for supplemental opioids.
RESULTS: The estimated ED90 was 500 µg (95% confidence interval [CI], 495.00-532.50 µg) for epidural hydromorphone and 3 mg (95% CI, 2.97-3.21 mg) for epidural morphine. Comparative analyses of postoperative VAS scores, adverse effects (nausea/vomiting and pruritus), and rescue hydromorphone consumption revealed no statistically significant differences between the two dosage groups.
CONCLUSION: The ED90 for post-cesarean analgesia was estimated to be 500 µg for epidural hydromorphone and 3 mg for epidural morphine. There were no statistically significant differences in adverse effects between the two drugs at their respective ED90 doses.
CLINICAL TRIAL REGISTRATION: ChiCTR2400084510.
METHODS: In this dose-finding trial, 80 patients undergoing cesarean delivery under combined spinal-epidural anesthesia (CSEA) were randomized to receive a single epidural injection of either hydromorphone or morphine after uterine closure. The dose of each agent was determined using a biased-coin up-and-down sequential allocation method to estimate the ED90. In addition, all patients received standardized multimodal analgesia postoperatively. Satisfactory analgesia was defined as a visual analogue scale (VAS) score ≤3 within 12 hours after cesarean delivery, without the need for supplemental opioids.
RESULTS: The estimated ED90 was 500 µg (95% confidence interval [CI], 495.00-532.50 µg) for epidural hydromorphone and 3 mg (95% CI, 2.97-3.21 mg) for epidural morphine. Comparative analyses of postoperative VAS scores, adverse effects (nausea/vomiting and pruritus), and rescue hydromorphone consumption revealed no statistically significant differences between the two dosage groups.
CONCLUSION: The ED90 for post-cesarean analgesia was estimated to be 500 µg for epidural hydromorphone and 3 mg for epidural morphine. There were no statistically significant differences in adverse effects between the two drugs at their respective ED90 doses.
CLINICAL TRIAL REGISTRATION: ChiCTR2400084510.