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Effect of Paracervical Block on Postoperative Pain After vNOTES Uterosacral Ligament Suspension

RecruitingNAAges 18 Years - anyFemaleErkan Gol
NCT07440576 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Bupivacaine
  • Normal Saline
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Where

1 site
Bakirkoy Dr. Sadi Konuk Training and Research Hospital
Istanbul, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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