RecruitingNot ApplicableNCT07440576

Effect of Paracervical Block on Postoperative Pain After vNOTES Uterosacral Ligament Suspension

A Prospective Randomized Double-Blind Placebo-Controlled Trial Evaluating the Effect of Paracervical Block on Postoperative Pain After vNOTES Uterosacral Ligament Suspension


Sponsor

Erkan Gol

Enrollment

58 participants

Start Date

Mar 9, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effect of paracervical block on early postoperative pain after vaginal natural orifice transluminal endoscopic surgery (vNOTES) uterosacral ligament suspension. Eligible patients undergoing vNOTES uterosacral ligament suspension for benign gynecologic indications will be randomly assigned in a 1:1 ratio to receive either 10 mL of 0.5% bupivacaine or 10 mL of normal saline as a paracervical injection during surgery. The primary outcome is postoperative pain assessed using the Visual Analog Scale (VAS) at 6 hours after surgery. Secondary outcomes include pain scores at multiple time points within 24 hours, total analgesic consumption, length of hospital stay, and patient satisfaction. The study aims to determine whether paracervical block provides clinically meaningful pain reduction in the early postoperative period following vNOTES procedures.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Bupivacaine and a drug called Normal Saline for people with pelvic organ prolapse (pop) and postoperative pain. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBupivacaine

A total of 10 mL of 0.5% bupivacaine will be administered as a paraservical injection during vNOTES uterosacral ligament suspension. The solution will be prepared in identical syringes by independent personnel to maintain blinding.

DRUGNormal Saline

A total of 10 mL of 0.9% normal saline will be administered as a paraservical injection during vNOTES uterosacral ligament suspension. The solution will be prepared in identical syringes to ensure blinding.


Locations(1)

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Istanbul, Istanbul, Turkey (Türkiye)

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NCT07440576


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