Paracervical block for pain control after vNOTES uterosacral ligament suspension
Official title: A Prospective Randomized Double-Blind Placebo-Controlled Trial Evaluating the Effect of Paracervical Block on Postoperative Pain After vNOTES Uterosacral Ligament Suspension
Run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital · NCT07440576 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 58 (estimated) |
| Sponsor | Bakirkoy Dr. Sadi Konuk Research and Training Hospital Government |
| Drugs / interventions | radiation |
| Locations | 1 site (Istanbul, Istanbul) |
| Status | Recruiting |
| Started | March 9, 2026 |
| Main results expected | February 2027 |
| Study ends | February 2027 |
| Registry record updated | March 11, 2026 |
| Trial ID | NCT07440576 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Paracervical block has shown mixed results in other gynecologic procedures, and high-quality randomized data specifically for vNOTES are limited.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
PECS II vs SPSIP nerve blocks for pain after mastectomy
This study tests whether two ultrasound-guided nerve blocks (PECS II and SPSIP) differ in how much opioid patients need after mastectomy.
-
Palatal Shield Technique to Reduce Pain and Improve Healing After Free Gingival Graft
This randomized trial tests whether a collagen sponge with a protective palatal shield made of flowable resin helps reduce pain and improve healing after free gingival graft harvest.
-
Perfusion Index to Measure Postoperative Pain in Kids After Adenotonsillectomy
This study tests whether the perfusion index can reliably reflect pain levels in children aged 1–12 after adenotonsillectomy, comparing standard care with an added glossopharyngeal nerve block.
-
Anterior Knee Nerves Block vs Femoral Nerve Block for Knee Arthroscopy
This trial tests whether an anterior nerves of the knee (ANK) block provides similar pain relief to a femoral nerve block after knee arthroscopy in adults, aiming to reduce quadriceps weakness.
-
Natural Biopolymer-Based Irrigant for Root Canal Cleaning
This trial tests a chitosan nanoparticle irrigant to improve cleaning and disinfection in single-rooted teeth with asymptomatic pulp necrosis undergoing endodontic treatment.
-
Postoperative Pain Trajectories After Endometriosis Surgery
This study tests how pain changes after endometriosis surgery and whether perioperative pain testing can predict who will have ongoing pain.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.