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A Prospective Randomized Double-Blind Placebo-Controlled Trial Evaluating the Effect of Paracervical Block on Postoperative Pain After vNOTES Uterosacral Ligament Suspension

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Bakirkoy Dr. Sadi Konuk Training and Research Hospital
RECRUITING
Istanbul
Contact Information
Primary
Erkan Göl, MD
drerkangol@gmail.com
+905398517917
Backup
Keziban Doğan, Professor
drkzbn70@gmail.com
+905356336207
Time Frame
Start Date: 2026-03-09
Estimated Completion Date: 2027-02
Participants
Target number of participants: 58
Treatments
Experimental: Paracervical Block (Bupivacaine)
Participants will receive 10 mL of 0.5% bupivacaine administered as a paraservical injection during vNOTES uterosacral ligament suspension.
Placebo_comparator: Placebo (Normal Saline)
Participants will receive 10 mL of 0.9% normal saline administered as a paraservical injection during vNOTES uterosacral ligament suspension.
Related Therapeutic Areas
Sponsors
Leads: Erkan Gol

This content was sourced from clinicaltrials.gov