Presacral Nerve Block Versus Sham Block on Post-operative Pain for Total Laparoscopic Hysterectomy

NCT05953766 | Recruiting Phase 2 FDA Drug

• 1 other identifier: REB# 21-0104-A
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Hysterectomy; Presacral nerve block; Laparoscopy; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Early post-operative pain at 3 hours following surgery

  Early post-operative pain measured at 3-hours following surgery by a self-administered numeric pain rating scale (NRS) on a scale from 0 to 10, with 0 indicating no pain and 10 indicating the worst pain imaginable

  3 hours following surgery

Secondary Outcomes (1)

• Post-operative pain at other time points

  1 hour, 2 hour, and post-operative days 1, 2 and 7

Other Outcomes (2)

• Post-operative narcotic usage

  Post-operative days 1, 2 and 7

• Adverse effects/complication rates

  Post-operative days 1, 2 and 7

Study Arms (2)

Presacral Nerve Block

EXPERIMENTAL

Presacral nerve block using 20mL of local ropivacaine 5.0mg/ml instilled in the presacral space

Drug: Ropivacaine injection

Sham Block

SHAM COMPARATOR

20mL of normal saline (sham block) instilled in the presacral space

Drug: Normal saline injection

Interventions

Ropivacaine injection DRUG

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

Also known as: Naropin

Presacral Nerve Block

Normal saline injection DRUG

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

Also known as: Sham block, 0.9% Sodium Chloride

Sham Block

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Undergoing total laparoscopic hysterectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Mara Sobel, MD

CONTACT

416 586 8273; mara.sobel@sinaihealth.ca

Shakiba Ardestani, MD

CONTACT

6478185422; shakiba.ardestani@mail.utoronto.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The surgeon, research team, participants and data analysts will be blinded to treatment group. Our clinic nurse, who works 5 days per week in our ambulatory office and who will have no other role in this study, will prepare the active and placebo syringes and label the syringes according to the randomization list. Each syringe will be prepared individually and provided to the surgeon on the day of surgery. Study participants will be randomized on the day of surgery. The surgeon will instill the drug/placebo from the labeled syringe into the presacral space as the first step prior to starting the hysterectomy.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will create a randomization list using a computer-generated allocation sequence in equal ratio with study numbers 1 to 60.

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: July 20, 2023
• Study Start: July 24, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)