Evaluating the efficacy and safety of perianal injection of liposomal ropivacaine HR18034 for postoperative analgesia following hemorrhoidectomy: A multicenter, randomized, double-blind, controlled phase II clinical trial
Authors' conclusion
HR 18034 380 mg showed superior analgesic efficacy and equivalent safety compared to ropivacaine 75 mg after hemorrhoidectomy, thus preliminarily determined as minimum effective dose.
Study context
- Population
- Patients undergoing hemorrhoidectomy, 19 centres in China, October–November 2022
- Participants
- 85 patients · 19 centres
- Comparison
- Perianal liposomal ropivacaine HR18034 190, 285 or 380 mg vs ropivacaine 75 mg
- Primary endpoint
- AUC of resting-state NRS score–time curve
- Follow-up
- 72 h after injection
Methodological detailsmulticentre, double-blind, phase II
- Multicentre
- Double-blind
- Phase II
Primary result
As reported in the abstract
AUC of NRS score–time curve (rest and moving) · 24 h, 48 h, and 72 h
- Significantly lower with HR 18034 380 mg than ropivacaine 75 mg
- Superiority not observed with HR18034 190 mg and 285 mg
Further findings
Cumulative morphine consumption for rescue analgesia
- No difference between HR 18034 groups and ropivacaine
Original publication
Evaluating the efficacy and safety of perianal injection of liposomal ropivacaine HR18034 for postoperative analgesia following hemorrhoidectomy: A multicenter, randomized, double-blind, controlled phase II clinical trial. J Clin Anesth. Published 27 June 2024. doi:10.
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