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Paracervical Injection and Opioid Use After Vaginal Hysterectomy for Prolapse

StatusCompleted
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial completed Final enrollment: 50 participants (planned 56) · Study completion date changed from estimate of Dec 2026 to Sep 24, 2026 · Secondary endpoints: details revised at 1 of 4 entries · 2 more Show 5 more changesShow less
    • Final enrollment: 50 participants (planned 56)
    • Study completion date changed from estimate of Dec 2026 to Sep 24, 2026
    • Secondary endpoints: details revised at 1 of 4 entries
    • Eligibility criteria expanded, about 5 words
    • Study description expanded, about 3 words
  2. Enrollment closed, study ongoing Primary completion moved earlier from Oct 2026 to Aug 12, 2026 · Site details revisedv3 Show 2 more changesShow less
    • Primary completion moved earlier from Oct 2026 to Aug 12, 2026
    • Site details revised
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Oct 2025 to Oct 20, 2025 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Oct 2025 to Oct 20, 2025
    • Site details revised
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07213635
Lead Sponsor University of North Carolina, Chapel Hill
Conditions Opioid Use, Surgical Recovery, Vaginal Hysterectomy, Prolapse Pelvic, Postoperative Pain
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov