Extended-Release Dinalbuphine Sebacate Versus Intravenous Patient-Controlled Analgesia with Fentanyl for Postoperative Moderate-to-Severe Pain: A Randomized Controlled Trial

INTRODUCTION: Post-operative pain control remains unsatisfactory in patients after laparotomy. This study aimed to evaluate the efficacy, safety, and quality of life with a single dose of extended-release dinalbuphine sebacate (ERDS) pre-operatively to intravenous patient-controlled analgesia (PCA) with fentanyl in patients undergoing laparotomy. METHODS: This was a prospective, open-label, randomized controlled study. Of 110 randomized patients, 107 completed all assessments. The area under the curve (AUC) of visual analogue scale (VAS) from baseline to 48 h after surgery, VAS throughout 7 days after surgery, post-operative analgesics use, quality of life, satisfaction, and safety were evaluated. RESULTS: The AUC of VAS from baseline to 48 h after surgery were 118.6 [97.5% confidence interval (CI) 95.6–141.6] in ERDS group and 176.13 (97.5% CI 150.8–201.4) in PCA group, which showed the non-inferiority because the upper limit of the 97.5% CIs of ERDS group was lower than the lower limit of PCA group (P < 0.001), but also had superiority in favor of ERDS group (P < 0.001). ERDS group reported a significant reduction in VAS pain intensity at 4, 24, 32, 72, 120, and 144 h after surgery, and better quality of life (P < 0.05). The safety profile was comparable between ERDS and PCA groups. CONCLUSIONS: In patients undergoing laparotomy, a single dose of dinalbuphine sebacate was superior to intravenous PCA with fentanyl on lower pain intensity and better quality of life. TRIAL REGISTRATION: NCT03296488.