Actively Recruiting
Effect of Paracervical Block on Postoperative Pain After vNOTES Uterosacral Ligament Suspension: A Randomized Double-Blind Placebo-Controlled Trial
Led by Erkan Gol · Updated on 2026-03-11
58
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of paracervical block on early postoperative pain after vaginal natural orifice transluminal endoscopic surgery (vNOTES) uterosacral ligament suspension in female patients with pelvic organ prolapse. This prospective, randomized, double-blind, placebo-controlled trial aims to determine whether paracervical block with local anesthetic reduces pain in the early recovery period following this minimally invasive gynecologic surgery. Participants will be randomly assigned to receive either 10 mL of 0.5% bupivacaine or 10 mL of normal saline as a paracervical injection during the vNOTES uterosacral ligament suspension procedure. The study uses computer-generated randomization with allocation concealment, and the solutions are prepared in identical syringes to maintain blinding. Treatment is given during surgery, and participants are followed postoperatively. During the study, postoperative pain will be assessed using the Visual Analog Scale (VAS) at several time points up to 24 hours after surgery, with the primary outcome measured at 6 hours. Secondary measures include total pain scores within 24 hours, analgesic use, hospital stay length, and patient satisfaction. The trial monitors recovery and pain management closely to evaluate if paracervical block offers meaningful pain relief.
CONDITIONS
Brief 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 oophorectomy followed by vNOTES uterosacral ligament suspension
- ASA physical status I-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 hepatic or renal impairment
- Coagulopathy or anticoagulant therapy contraindicating injection
- Active pelvic infection
- Pregnancy
- Inability to understand the pain scoring system
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo vNOTES uterosacral ligament suspension surgery during which they receive a paracervical injection of either bupivacaine or normal saline. Postoperative pain and recovery are closely monitored within the first 24 hours after surgery.
1 surgery visit and assessments at 0, 1, 2, 4, 6, 12, and 24 hours postoperatively
Duration - Up to 30 days
Participants are followed up to assess patient satisfaction and length of hospital stay after surgery.
Visits as needed until hospital discharge and for follow-up assessments up to 30 days postoperatively
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
K
Keziban Doğan, Professor
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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