Paracervical numbing injection to reduce 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
This will try giving a numbing injection around the cervix during vaginal hysterectomy for prolapse to see if it reduces pain and the need for opioid pain medicines afterward.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Raleigh, North Carolina) |
| Trial ID | NCT07213635 on ClinicalTrials.gov |
What this trial studies
This randomized, placebo-controlled phase 4 trial compares an intraoperative paracervical block (bupivacaine with lidocaine) to a saline placebo given after the patient is asleep but before the rest of the surgery. Participants will record opioid use and pain scores from the day of surgery through seven days post-op, with pain assessments in the recovery area, at one day, and at seven days after surgery. Secondary outcomes include surgical recovery times and the incidence of adverse events. The trial is conducted at the University of North Carolina Urogynecology and Reconstructive Pelvic Surgery at REX in Raleigh, NC.
Who should consider this trial
Good fit: People scheduled for a vaginal hysterectomy with concurrent prolapse repair who are at least 50 kg, English-speaking, not pregnant, and not allergic to bupivacaine.
Not a fit: Patients who are allergic to bupivacaine, weigh less than 50 kg, are pregnant, undergo a non-vaginal hysterectomy approach, or cannot receive care at the UNC REX site are unlikely to be eligible or benefit.
Why it matters
Potential benefit: If successful, the injection could lower the amount of opioid medication patients need and reduce postoperative pain after vaginal hysterectomy for prolapse.
How similar studies have performed: Paracervical blocks have been used for other gynecologic procedures with mixed results, so using this block specifically to reduce opioids after vaginal hysterectomy is not yet definitively proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Raleigh, North Carolina
- University of North Carolina Urogynecology and Reconstructive Pelvic Surgery at REX — Raleigh, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Bertie Geng, MD — University of North Carolina
- Study coordinator: Bertie Geng, MD
- Email: bertie.geng@unchealth.unc.edu
- Phone: 984-974-0496
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.