Effect of Paracervical Block on Postoperative Opioid Use in Vaginal Hysterectomy for Prolapse: a Randomized, Placebo-Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The goal of the study to see if giving a numbing medicine around the cervix (called a paracervical block) during vaginal hysterectomy with prolapse repair helps people feel less pain and need fewer strong pain medicines afterward. The main question it aims to answer is: • Does receiving a paracervical block at the time of vaginal hysterectomy with prolapse repair reduce postoperative opioid use? Researchers will compare opioid use in participants who receive the an injected numbing medicine (bupivacaine with lidocaine) to those that receive a saltwater liquid placebo. Participants will: * Receive either an injection of the numbing medicine (bupivacaine with lidocaine) or saltwater liquid placebo after they are asleep but before any other parts of the surgery are done * Record and report pain medications used for 7 days after surgery * Report pain scores before discharge from the post anesthesia recovery area on day of surgery as well as 1 and 7 days after surgery * Complete a surgical recovery questionnaire during 6 week postoperative visit * Complete a one page multiple-choice test on pelvic organ prolapse

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• Individuals undergoing vaginal hysterectomy with concomitant prolapse repair procedure

Locations
United States
North Carolina
University of North Carolina Urogynecology and Reconstructive Pelvic Surgery at REX
RECRUITING
Raleigh
Contact Information
Primary
Bertie Geng, MD
bertie.geng@unchealth.unc.edu
984-974-0496
Backup
Marcella Willis-Gray, MD
Marcella_Willis-Gray@med.unc.edu
Time Frame
Start Date: 2025-10-20
Estimated Completion Date: 2026-12
Participants
Target number of participants: 56
Treatments
Experimental: Paracervical block
Participants randomized to this experimental arm will receive a paracervical block with 0.5% bupivacaine with epinephrine at the time of vaginal hysterectomy with prolapse repair
Placebo_comparator: Placebo
Participants randomized to this experimental arm will receive a placebo paracervical injection with normal saline at the time of vaginal hysterectomy with prolapse repair
Related Therapeutic Areas
Sponsors
Leads: University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov