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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorErkan Gol

About this trial

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 criteria

Qualifiers

Female patients aged 18 years or older

Symptomatic pelvic organ prolapse requiring uterosacral ligament suspension (USLS)

Planned hysterectomy (vaginal hysterectomy or vNOTES hysterectomy) with concomitant BS or BSO, followed by vNOTES uterosacral ligament suspension

ASA physical status I-III

Disqualifiers

Known allergy or hypersensitivity to bupivacaine or local anesthetic agents

Chronic opioid use or chronic pain disorders

Previous pelvic radiation therapy

Severe hepatic or renal impairment

Trial design

Treatments tested in this trial

  • Bupivacaine
  • Normal Saline

Treatment groups

58 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Erkan Gol

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Sponsor institution