A Randomized Controlled Trial (RCT) Comparing Presacral Nerve Block Versus Sham Block on Post-operative Pain in Women Undergoing Total Laparoscopic Hysterectomy.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:
• 18 years of age or older
• Undergoing total laparoscopic hysterectomy
Locations
Other Locations
Canada
Mount Sinai Hospital
RECRUITING
Toronto
Contact Information
Primary
Mara Sobel, MD
mara.sobel@sinaihealth.ca
416 586 8273
Backup
Shakiba Ardestani, MD
shakiba.ardestani@mail.utoronto.ca
6478185422
Time Frame
Start Date: 2025-09-24
Estimated Completion Date: 2026-07
Participants
Target number of participants: 60
Treatments
Experimental: Presacral Nerve Block
Presacral nerve block using 20mL of local ropivacaine 5.0mg/ml instilled in the presacral space
Sham_comparator: Sham Block
20mL of normal saline (sham block) instilled in the presacral space
Related Therapeutic Areas
Sponsors
Leads: Mount Sinai Hospital, Canada