Presacral nerve block to reduce pain after total laparoscopic hysterectomy.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mount Sinai Hospital
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Mara Sobel, MD
• Email: mara.sobel@sinaihealth.ca
• Phone: 416 586 8273

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.