Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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