NCT07213635 Paracervical Injection and Opioid Use After Vaginal Hysterectomy for Prolapse
| NCT ID | NCT07213635 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Opioid Use |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2025-10-20 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 56 participants in total. It began in 2025-10-20 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Bertie Geng, MD
PRINCIPAL INVESTIGATOR
University of North Carolina
Frequently Asked Questions
Who can join the NCT07213635 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Opioid Use. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07213635 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07213635 currently recruiting?
Yes, NCT07213635 is actively recruiting participants. Contact the research team at bertie.geng@unchealth.unc.edu for enrollment information.
Where is the NCT07213635 trial being conducted?
This trial is being conducted at Raleigh, United States.
Who is sponsoring the NCT07213635 clinical trial?
NCT07213635 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Bertie Geng, MD at University of North Carolina. The trial plans to enroll 56 participants.