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Liposomal Bupivacaine vs Ropivacaine for Post-hemorrhoidectomy Analgesia
Sponsor: Tongliao City People's Hospital
Summary
This is a single-center, prospective, randomized, double-blind controlled trial comparing the analgesic efficacy, quality of recovery, and safety of perianal wound infiltration with multivesicular liposomal bupivacaine (266 mg) versus ropivacaine hydrochloride (200 mg) in patients undergoing Milligan-Morgan open hemorrhoidectomy under spinal anesthesia. Both solutions are diluted to a total volume of 30 mL and infiltrated at six predefined perianal positions at the end of surgery. The primary outcome is the resting visual analog scale (VAS) pain score at 24 hours after surgery. Secondary outcomes include resting and movement-evoked VAS pain scores at 4, 6, 12, 24, and 48 hours, cumulative rescue analgesic consumption during postoperative days 1-3, Quality of Recovery-40 (QoR-40) scores on postoperative days 1-3, and adverse events within 72 hours after surgery.
Official title: Liposomal Bupivacaine Versus Ropivacaine for Wound Infiltration Analgesia After Milligan-Morgan Open Hemorrhoidectomy: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2026-08-30
Completion Date
2027-09-30
Last Updated
2026-08-31
Healthy Volunteers
No
Interventions
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
266 mg (20 mL) diluted with 10 mL normal saline to total 30 mL; infiltrated at six perianal positions at end of surgery
Ropivacaine Hydrochloride
200 mg (20 mL) diluted with 10 mL normal saline to total 30 mL; infiltrated at six perianal positions at end of surgery
Locations (1)
Tongliao People's Hospital
Neimeng, Tongliao, China