Recruiting
Phase 2

Ropivacaine

Sponsor:

Mount Sinai Hospital, Canada

Code:

NCT05953766

Conditions

Post-operative Pain

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Ropivacaine injection

Normal saline injection

Study Details

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.

Conditions

Post-operative Pain

Study ID

NCT05953766

Start date

Sep 24, 2025

Status verified date

Jul, 2025

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

Interventions

Ropivacaine injection

Presacral nerve block using 20mL of local ropivacaine 5.0mg/ml

Normal saline injection

Sham block using 20 mL of normal saline (0.9% sodium chloride)

Primary outcome measure

  • Early post-operative pain at 3 hours following surgery [ Time Frame: 3 hours following surgery ]

Central Contacts and Locations

Central contacts

Mara Sobel, MD

416 586 8273mara.sobel@sinaihealth.ca

Shakiba Ardestani, MD

6478185422shakiba.ardestani@mail.utoronto.ca

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contacts

Mara Sobel, MD, MSc

416 586 8273Mara.Sobel@sinaihealth.ca

More Information

Sponsor

Mount Sinai Hospital, Canada

Last update posted

Apr 6, 2026

Last verified

Jul, 2025

Keywords

  • Hysterectomy
  • Presacral nerve block
  • Laparoscopy
  • Anesthesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada on 2026-04-06.