Presacral Nerve Block Versus Sham Block on Post-operative Pain for Total Laparoscopic Hysterectomy

NCT05953766 · tracked via the Priya Life Science Canada tracker

Sponsor

Mount Sinai Hospital, Canada

Phase

Phase 2

Started

2025-09-24

Last updated

2026-04-06

Condition(s) studied

Post-operative Pain

Investigational drug(s) / intervention(s)

Ropivacaine injection →Normal saline injection

Ropivacaine injection: Presacral nerve block using 20mL of local ropivacaine 5.0mg/ml

Normal saline injection: Sham block using 20 mL of normal saline (0.9% sodium chloride)

Study 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

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

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

Primary outcome measure(s)

Early post-operative pain at 3 hours following surgery — 3 hours following surgery
Early post-operative pain measured at 3-hours following surgery by a self-administered numeric pain rating scale (NRS) on a scale from 0 to 10, with 0 indicating no pain and 10 indicating the worst pain imaginable

Trial sites (1)

Facility	City	Region	Status
Mount Sinai Hospital	Toronto	Ontario	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05953766 on ClinicalTrials.gov ↗ ← All trials in Canada