Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT07440576

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

Led by Erkan Gol · Updated on 2026-03-11

58

Participants Needed

1

Research Sites

47 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 18 years or older
  • Symptomatic pelvic organ prolapse requiring uterosacral ligament suspension
  • Planned vaginal or vNOTES hysterectomy with bilateral salpingectomy or salpingo-oophorectomy followed by vNOTES uterosacral ligament suspension
  • ASA physical status I to III
  • Ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • Known allergy or hypersensitivity to bupivacaine or local anesthetic agents
  • Chronic opioid use or chronic pain disorders
  • Previous pelvic radiation therapy
  • Severe liver or kidney impairment
  • Bleeding disorders or use of anticoagulant therapy contraindicating injection
  • Active pelvic infection
  • Pregnancy
  • Inability to understand the pain scoring system

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Istanbul, Istanbul, Turkey (Türkiye), 34147

Actively Recruiting

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Research Team

E

Erkan Göl, MD

CONTACT

K

Keziban Doğan, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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