MedTrace Logo

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

NCT07440576 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-03-11

No results posted yet for this study

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.

Conditions

  • Pelvic Organ Prolapse (POP)
  • Postoperative Pain

Interventions

DRUG

Bupivacaine

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.

DRUG

Normal 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.

Sponsors & Collaborators

  • Erkan Gol

    lead OTHER_GOV

Principal Investigators

  • Erkan Göl, MD · Bakırkoy Dr. Sadi Konuk Training and Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-09
Primary Completion
2027-02-28
Completion
2027-02-28

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07440576 on ClinicalTrials.gov