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NOT YET RECRUITING
NCT07795203
PHASE4

Liposomal Bupivacaine vs Ropivacaine for Post-hemorrhoidectomy Analgesia

Sponsor: Tongliao City People's Hospital

View on ClinicalTrials.gov

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

DRUG

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

DRUG

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