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

NCT ID: NCT04354415

Last Updated: 2020-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-25
• Study Completion Date: 2020-04-06

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.

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%.

Conditions

Carpal Tunnel Syndrome; Trigger Finger

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tourniquet Group

Tourniquet application during procedures

Group Type: ACTIVE_COMPARATOR

Carpal tunnel or trigger finger release

Intervention Type: PROCEDURE

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

Non-Tourniquet group

No application of tourniquet for procedures

Group Type: EXPERIMENTAL

Carpal tunnel or trigger finger release

Intervention Type: PROCEDURE

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

Interventions

Carpal tunnel or trigger finger release

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maisonneuve-Rosemont Hospital

OTHER

Sponsor Role: lead

Responsible Party

Eli Saleh

Plastic Surgery Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dominique M Tremblay, MD

Role: PRINCIPAL_INVESTIGATOR

Université de Montréal (Hospital Maisonneuve-Rosemont)

Locations

Hospital Maisonneuve Rosemont

Montreal East, Quebec, Canada

Countries

Canada

Other Identifiers

CER-CEMTL(6518)

Identifier Type: -

Identifier Source: org_study_id