๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-20

Paracervical Injection and Opioid Use After Vaginal Hysterectomy for Prolapse (NCT07213635)

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

๐Ÿ”ต Active, Not Recruiting Phase4 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: University of North Carolina, Chapel Hill

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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: โ€ข 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

Who can join: Review the eligibility criteria below.

Location: University of North Carolina Urogynecology and Reconstructive Pelvic Surgery at REX โ€” Raleigh, North Carolina

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • University of North Carolina Urogynecology and Reconstructive Pelvic Surgery at REX โ€” Raleigh, North Carolina

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Opioid Use clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—