Paracervical block for pain control after vNOTES uterosacral ligament suspension
A Prospective Randomized Double-Blind Placebo-Controlled Trial Evaluating the Effect of Paracervical Block on Postoperative Pain After vNOTES Uterosacral Ligament Suspension
This will test whether a paracervical injection of bupivacaine reduces early postoperative pain in women having vNOTES uterosacral ligament suspension for pelvic organ prolapse.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Bakirkoy Dr. Sadi Konuk Research and Training Hospital Government |
| Drugs / interventions | radiation |
| Locations | 1 site (Istanbul, Istanbul) |
| Trial ID | NCT07440576 on ClinicalTrials.gov |
What this trial studies
This is a single-center, randomized, double-blind, placebo-controlled trial in 58 patients undergoing vNOTES uterosacral ligament suspension for benign indications. Participants are randomized 1:1 to receive a 10 mL paracervical injection of 0.5% bupivacaine or 10 mL normal saline prepared and administered in a blinded fashion. The primary outcome is pain on the Visual Analog Scale at 6 hours after surgery, with additional pain measurements up to 24 hours, total analgesic consumption, length of stay, and patient satisfaction as secondary outcomes. Analyses will follow the intention-to-treat principle.
Who should consider this trial
Good fit: Women aged 18 years or older with symptomatic pelvic organ prolapse scheduled for vNOTES uterosacral ligament suspension (with planned hysterectomy) who are ASA I–III and can give informed consent.
Not a fit: Patients with allergy to bupivacaine or other local anesthetics, chronic opioid use or chronic pain disorders, prior pelvic radiation, severe hepatic/renal impairment, coagulopathy or anticoagulation contraindicating injection, active pelvic infection, pregnancy, or inability to use the pain scale are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, adding a paracervical block could reduce early postoperative pelvic pain and lower short-term opioid needs after vNOTES procedures.
How similar studies have performed: Paracervical block has shown mixed results in other gynecologic procedures, and high-quality randomized data specifically for vNOTES are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Istanbul, Istanbul
- Bakirkoy Dr. Sadi Konuk Training and Research Hospital — Istanbul, Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Erkan Göl, MD — Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Study coordinator: Erkan Göl, MD
- Email: drerkangol@gmail.com
- Phone: +905398517917
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.