NCT07440576 Effect of Paracervical Block on Postoperative Pain After vNOTES Uterosacral Ligament Suspension
| NCT ID | NCT07440576 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erkan Gol |
| Condition | Pelvic Organ Prolapse (POP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 58 participants |
| Start Date | 2026-03-09 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 58 participants in total. It began in 2026-03-09 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 * Ability to provide written informed consent Exclusion Criteria: * 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 * Coagulopathy or anticoagulant therapy contraindicating injection * Active pelvic infection * Pregnancy * Inability to understand the pain scoring system
Contact & Investigator
Erkan Göl, MD
PRINCIPAL INVESTIGATOR
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Frequently Asked Questions
Who can join the NCT07440576 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Pelvic Organ Prolapse (POP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07440576 currently recruiting?
Yes, NCT07440576 is actively recruiting participants. Contact the research team at drerkangol@gmail.com for enrollment information.
Where is the NCT07440576 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07440576 clinical trial?
NCT07440576 is sponsored by Erkan Gol. The principal investigator is Erkan Göl, MD at Bakirkoy Dr. Sadi Konuk Research and Training Hospital. The trial plans to enroll 58 participants.