Presacral nerve block to reduce pain after total laparoscopic hysterectomy.
A Randomized Controlled Trial (RCT) Comparing Presacral Nerve Block Versus Sham Block on Post-operative Pain in Women Undergoing Total Laparoscopic Hysterectomy.
This trial tries a presacral nerve block with ropivacaine versus a saline sham to see if it reduces pain after total laparoscopic hysterectomy in adults.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Mount Sinai Hospital, Canada Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05953766 on ClinicalTrials.gov |
What this trial studies
This is a single-center, parallel-group, randomized controlled phase 2 trial comparing a presacral nerve block with 20 mL ropivacaine (5.0 mg/mL) to a 20 mL normal saline sham given at the time of total laparoscopic hysterectomy. Sixty patients will be randomized 1:1, with study syringes prepared and labeled by a clinic nurse unaffiliated with other study activities to maintain blinding. Participants are recruited by convenience sampling from Mount Sinai Hospital outpatient gynecology clinics and provide informed consent before surgery. The trial's primary focus is post-operative pain after surgery, with collection of related outcomes such as analgesic use.
Who should consider this trial
Good fit: Adults aged 18 years or older scheduled for total laparoscopic hysterectomy at Mount Sinai Hospital who do not meet the exclusion criteria are eligible.
Not a fit: Patients with prior presacral neurectomy, chronic opioid use, fibromyalgia, BMI >50, advanced gynecologic cancer, or who cannot communicate or consent (including language barriers) are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the presacral nerve block could reduce post-operative pain and lower opioid requirements after laparoscopic hysterectomy.
How similar studies have performed: A prior report by Rapp et al. used a similar 20 mL ropivacaine instillation at open hysterectomy with suggestive results, but randomized data for presacral block in laparoscopic hysterectomy remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario
- Mount Sinai Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Mara Sobel, MD
- Email: mara.sobel@sinaihealth.ca
- Phone: 416 586 8273
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.