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

Comparing Open Carpal Tunnel or Trigger Finger Release Procedures Performed Under Local Anesthesia With or Without the Use of a Tourniquet: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome; Trigger Finger
• Intervention / Treatment: Procedure: Carpal tunnel or trigger finger release

Detailed Description

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 will be a parallel study by design where the allocation ratio between the two groups will be set to be 1:1.

Patients are to be recruited on the day of the procedure. Upon arrival, they will be presented with the research project and given the information pamphlet and consent forms. Sufficient time to read these documents will be allocated.

For the purpose of this RCT, the same volume and concentration of the solution will be injected in the surgical site prior to entering the operating room, thereby allowing epinephrine to full take effect. The solution used by the hand surgeons will include 8 cc of 2% xylocaine with epinephrine mixed with 3 cc of 0.5% Marcaine with epinephrine. Eight millilitres will be used for the CT releases and 4 millilitres for the TF releases. Once in the room, the patient's arm will be disinfected and draped in a similar fashion, and surgery will proceed without inflation of the tourniquet. A system will be implemented so that before patient A's surgery begins, patient B will be injected in a separate room. By the time patient B's surgery begins, a minimum of 30 minutes will have elapsed since his injection. Other than the differences in tourniquet use, all other procedure-specific elements will be identical, namely the size and location of the incision, the surgical technique, skin closure, type of dressing, rehabilitation and post-operative follow-up.

The primary outcome of interest is peri-operative patient experience. The aim is to demonstrate the superiority of the no tourniquet technique with respect to the patients' subjective experience peri-operatively. This will be measured based on a numerical rating scale (NRS) for pain, anxiety and overall satisfaction. As secondary outcomes, operative time, bleeding control and short-term complication rates will be looked at and compared between the two groups.

To achieve statistical significance, at least 31 patients will be needed in each group to show a minimal decrease of 33% on the NRS scales evaluation of the postoperative pain and overall experience with an α error of 0,05 and a power of 80%.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal-Est, Quebec, Canada, H1T 2M4
      • Hospital Maisonneuve Rosemont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. contra-indications for subcutaneous epinephrine use
2. history of digital gangrene
3. buerger's disease
4. previous replantation
5. Raynaud
6. Sclerodactyly.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Tourniquet Group; Tourniquet application during procedures	Procedure: Carpal tunnel or trigger finger release; Carpal tunnel or trigger finger release with and without the use of tourniquet
EXPERIMENTAL: Non-Tourniquet group; No application of tourniquet for procedures	Procedure: Carpal tunnel or trigger finger release; Carpal tunnel or trigger finger release with and without the use of tourniquet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	time from beginning to end of surgery	Assessed in the immediate post-operative period
Bleeding levels	3-point ordinal scale: No bleeding; minor bleeding controlled with dabbing; bleeding requiring use of electrocautery	Assessed peri-operatively and noted in the immediate post-operative period
Peri-operative complication	Peri-operative complications including nerve or tendon damage	In the immediate post-operative period
Post-operative complications	Hematoma, infection and wound dehiscence/breakdown	1 week

Collaborators and Investigators

• Sponsor: Maisonneuve-Rosemont Hospital
• Investigators: Principal Investigator: Dominique M Tremblay, MD, Université de Montréal (Hospital Maisonneuve-Rosemont)

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 25, 2018
• Primary Completion (ACTUAL): June 20, 2019
• Study Completion (ACTUAL): April 6, 2020

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (ACTUAL): April 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 26, 2020
• Last Update Submitted That Met QC Criteria: May 21, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Tourniquet; WALANT; Patient-Centered
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Tendinopathy; Tendon Entrapment; Carpal Tunnel Syndrome; Trigger Finger Disorder
• Other Study ID Numbers: CER-CEMTL(6518)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No