RecruitingPhase 4NCT07213635

Paracervical Injection and Opioid Use After Vaginal Hysterectomy for Prolapse

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


Sponsor

University of North Carolina, Chapel Hill

Enrollment

56 participants

Start Date

Oct 20, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria1

  • Individuals undergoing vaginal hysterectomy with concomitant prolapse repair procedure

Exclusion Criteria4

  • Non-English speaking
  • Weight less than 50 kg
  • Allergy to bupivacaine
  • Pregnant

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGBupivacaine-epinephrine

Participants randomized to this experimental arm will receive a paracervical block with 10 mL 0.5% bupivacaine with epinephrine before their vaginal hysterectomy and prolapse repair

DRUGNormal saline

Participants randomized to this experimental arm will receive a placebo paracervical injection with 10 mL 0.5% normal saline before their vaginal hysterectomy and prolapse repair


Locations(1)

University of North Carolina Urogynecology and Reconstructive Pelvic Surgery at REX

Raleigh, North Carolina, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07213635


Related Trials