Trial intelligence / Profile preview

Presacral Nerve Block vs Sham Block for Post-operative Pain in Total Laparoscopic Hysterectomy

NCT05953766Phase 2

Key facts

Status
Recruiting
Start
Sep 2025
Primary completion
Jul 2026
Countries
1
Sponsor
Mount Sinai Hospital
Modality
Orthosteric Ligands
Conditions
postoperative pain
01

Overview

Phase 2, randomised, triple-blind trial of ropivacaine in postoperative pain (2 arms), sponsored by Mount Sinai Hospital. Primary endpoint: Early post-operative pain at 3 hours following surgery. Started Sep 2025; status: recruiting.

02

Design

2 arms
Study design
RandomizedTriple-blind
  • Presacral Nerve Block

    20mL of local ropivacaine 5.0mg/ml instilled in the presacral space

  • Sham Block

    20mL of normal saline instilled in the presacral space

03

Who it enrols

Women aged 18 and older undergoing total laparoscopic hysterectomy, excluding those with BMI > 50, gynecological cancer beyond stage 1, chronic opioid use, fibromyalgia, or previous presacral neurectomy.

04

Endpoints

Primary

  • Early post-operative pain at 3 hours following surgery

Secondary

  • Post-operative pain at other time points

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