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NCT07213635 · ClinicalTrials.gov registry record · Phase 4

Paracervical Injection and Opioid Use After Vaginal Hysterectomy for Prolapse

A Phase 4 study of Postoperative Pain and Opioid Use, sponsored by University of North Carolina, Chapel Hill.

Recruiting
Registry status
Phase 4
Development phase
56
Enrollment target
1
Study location

NCT07213635: Recruiting Phase 4 study of Postoperative Pain and Opioid Use, sponsored by University of North Carolina, Chapel Hill.

NCT07213635 is a Phase 4 study of Postoperative Pain and Opioid Use that is actively recruiting participants, run by University of North Carolina, Chapel Hill. The registered enrollment target is 56 participants, below the 231-participant average among 120 other Postoperative Pain trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07213635, a Phase 4 study of Postoperative Pain and Opioid Use, is actively recruiting participants, sponsored by University of North Carolina, Chapel Hill.

RECRUITING
Registry status
Phase 4
Development phase
56 participants
Enrollment target
1
Study location

Study 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

Primary Outcome

Mean postoperative opioid use converted to morphine milligram equivalents

Interventions

  • DRUG Normal saline
  • DRUG Bupivacaine-epinephrine

Study Locations (1)

North Carolina

  • University of North Carolina Urogynecology and Reconstructive Pelvic Surgery at REX - Raleigh

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2025-10-20
Est. Completion 2026-12
Phase Phase 4

What NCT07213635 shows while recruiting

NCT07213635 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 231-participant average among 120 other Postoperative Pain trials with a reported enrollment target (76% lower).

The record links to 5 conditions, with Postoperative Pain appearing as the primary indexed condition, and to 2 interventions - of which Normal saline is the first listed.

NCT07213635 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT07213635 about?

NCT07213635 is a clinical study titled "Paracervical Injection and Opioid Use After Vaginal Hysterectomy for Prolapse". 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 paracerv...

What is the current status of trial NCT07213635?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 56 participants. The study started on 2025-10-20. Estimated completion is 2026-12.

What conditions does trial NCT07213635 study?

This clinical trial studies the following conditions: Postoperative Pain, Opioid Use, Vaginal Hysterectomy, Surgical Recovery, Prolapse Pelvic.

What interventions are being tested in trial NCT07213635?

The interventions under investigation include: Normal saline (DRUG), Bupivacaine-epinephrine (DRUG).

Who is sponsoring clinical trial NCT07213635?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07213635 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Postoperative Pain

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07213635's enrollment target sits among peer trials

56 100th of 120 higher than 20 of 120 other Postoperative Pain trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Postoperative Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07213635, the US trial registry maintained by the National Library of Medicine. NCT07213635 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.