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Recruiting Phase 2 NCT05953766
Presacral Nerve Block Versus Sham Block on Post-operative Pain for Total Laparoscopic Hysterectomy
Trial Parameters
Condition Post-operative Pain
Sponsor Mount Sinai Hospital, Canada
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 60
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2025-07-24
Completion 2026-07
Interventions
Ropivacaine injectionNormal saline injection
Brief Summary
The study is a single-center parallel group randomized controlled trial comparing the administration of a presacral nerve block using 20mL of local ropivacaine 5.0mg/ml versus 20mL of normal saline (sham block) on post-operative pain following total laparoscopic hysterectomy.
Eligibility Criteria
Inclusion Criteria: * 18 years of age or older * Undergoing total laparoscopic hysterectomy Exclusion Criteria: * Previous presacral neurectomy * Concurrent surgical procedure other than salpingectomy and/or oophorectomy * Gynecological cancer beyond stage 1 disease * BMI \> 50 * Chronic opioid consumption * Fibromyalgia * Language barrier * Inability to communicate and provide consent
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