Tourniquet vs. No Tourniquet for Carpal Tunnel and Trigger Finger Release

NCT04354415 | Completed

• 1 other identifier: CER-CEMTL(6518)
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Trigger finger and carpal tunnel syndrome are two of the most common conditions treated by the hand surgeon. During these procedures, a tourniquet is often used to minimize bleeding and improve visualization of the operative field. However, it may be associated with pain and discomfort. To date, there are few prospective studies investigating the safety and outcomes of tourniquet-free minor hand procedures. Methods: This is a randomized controlled trial comparing patients undergoing open carpal tunnel or trigger finger release with or without the use of a tourniquet. This is an equivalence trial in terms of operative time, bleeding scores and peri-operative complication rates. In addition, peri-operative subjective patient experience will be investigated for both techniques. This will be measured based on a numerical rating scale (NRS) for pain, anxiety and overall satisfaction. The primary goal of this study is to to determine the efficacy and patient preference of the the differing techniques.

Conditions

Carpal Tunnel Syndrome; Trigger Finger

Keywords

Tourniquet; WALANT; Patient-Centered

Outcome Measures

Primary Outcomes (1)

• Peri-operative patient experience

  Based on Numerical rating scale (NRS) from 1 to 10. 1 being no pain at all, 10 being unbearable pain throughout procedure and post-operatively

  In the immediate post-operative period

Secondary Outcomes (4)

• Operative time

  Assessed in the immediate post-operative period

• Bleeding levels

  Assessed peri-operatively and noted in the immediate post-operative period

• Peri-operative complication

  In the immediate post-operative period

• Post-operative complications

  1 week

Study Arms (2)

Tourniquet Group

ACTIVE COMPARATOR

Tourniquet application during procedures

Procedure: Carpal tunnel or trigger finger release

Non-Tourniquet group

EXPERIMENTAL

No application of tourniquet for procedures

Procedure: Carpal tunnel or trigger finger release

Interventions

Carpal tunnel or trigger finger release PROCEDURE

Carpal tunnel or trigger finger release with and without the use of tourniquet

Non-Tourniquet group; Tourniquet Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must have been over the age of 18 at the time of surgery
• must have had either an electromyographically confirmed CTS and/or a clinically significant triggering or locking digit.
• Patients must have been able to understand and complete the pre-and post-operative questionnaires which were administered in either English or French.

You may not qualify if:

• contra-indications for subcutaneous epinephrine use
• history of digital gangrene
• buerger's disease
• previous replantation
• Raynaud
• Sclerodactyly.

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead

Study Sites (1)

Hospital Maisonneuve Rosemont

Montreal East, Quebec, H1T 2M4, Canada

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Trigger Finger Disorder

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Dominique M Tremblay, MD

  Université de Montréal (Hospital Maisonneuve-Rosemont)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Plastic Surgery Resident

Model Details: This was a randomized controlled trial comparing patients undergoing open carpal tunnel or trigger finger release with or without the use of a tourniquet. This was an equivalence trial in terms of operative time, bleeding scores and peri-operative complication rates. In addition, peri-operative subjective patient experience was investigated for both techniques. This was measured based on a numerical rating scale (NRS) for pain, anxiety and overall satisfaction.

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 21, 2020
• Study Start: October 25, 2018
• Primary Completion: June 20, 2019
• Study Completion: April 6, 2020
• Last Updated: May 26, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)