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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 Opioid Use and Postoperative Pain, sponsored by University of North Carolina, Chapel Hill.

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

NCT07213635 is a Phase 4 study of Opioid Use and Postoperative Pain that is actively recruiting participants, run by University of North Carolina, Chapel Hill. The registered enrollment target is 56 participants, below the 148,260-participant average among 105 other Opioid Use trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT07213635, a Phase 4 study of Opioid Use and Postoperative Pain, 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

Conditions Studied

Opioid Use Postoperative Pain Vaginal Hysterectomy Surgical Recovery Prolapse Pelvic

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

Sponsor

University of North Carolina, Chapel Hill

1,109 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07213635

The ClinicalTrials.gov registry entry for NCT07213635 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 148,260-participant average among 105 other Opioid Use trials with a reported enrollment target (100% lower). The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.

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

NCT07213635 reports 1 study location spanning 1 distinct geographic area - top geographies include 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: Opioid Use, Postoperative Pain, 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.