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
Sponsors and collaborators
Erkan Gol
Lead sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor institution