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NCT07213635PHASE4RecruitingAccepts Healthy Volunteers

Paracervical Injection and Opioid Use After Vaginal Hysterectomy for Prolapse

University of North Carolina, Chapel Hill

Start Date

10/20/2025

Completion Date

12/1/2026

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

Detailed Description

Secondary outcomes are to: 1. Compare postoperative pain scores in patients undergoing vaginal hysterectomy for prolapse repair who receive an intraoperative paracervical block compared to placebo 2. Compare surgical recovery times in patients undergoing vaginal hysterectomy for prolapse repair who receive an intraoperative paracervical block compared to placebo. 3. Examine incidence of adverse events in patients undergoing vaginal hysterectomy for prolapse repair who receive intraoperative paracervical block compared to placebo

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Individuals undergoing vaginal hysterectomy with concomitant prolapse repair procedure Exclusion Criteria: * Non-English speaking * Weight less than 50 kg * Allergy to bupivacaine * Pregnant

Interventions

DRUG

Bupivacaine-epinephrine

DRUG

Normal saline

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Conditions

Opioid UseSurgical RecoveryVaginal HysterectomyProlapse PelvicPostoperative Pain

Locations

University of North Carolina Urogynecology and Reconstructive Pelvic Surgery at REX

Raleigh, North Carolina 27607

United States