NCT05953766 Presacral Nerve Block Versus Sham Block on Post-operative Pain for Total Laparoscopic Hysterectomy
| NCT ID | NCT05953766 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mount Sinai Hospital, Canada |
| Condition | Post-operative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-09-24 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2025-09-24 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05953766 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Post-operative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05953766 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05953766 currently recruiting?
Yes, NCT05953766 is actively recruiting participants. Contact the research team at mara.sobel@sinaihealth.ca for enrollment information.
Where is the NCT05953766 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT05953766 clinical trial?
NCT05953766 is sponsored by Mount Sinai Hospital, Canada. The trial plans to enroll 60 participants.