Tourniquet vs. No Tourniquet for Carpal Tunnel and Trigger Finger Release
Primary Purpose
Carpal Tunnel Syndrome, Trigger Finger
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Carpal tunnel or trigger finger release
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Tourniquet, WALANT, Patient-Centered
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- contra-indications for subcutaneous epinephrine use
- history of digital gangrene
- buerger's disease
- previous replantation
- Raynaud
- Sclerodactyly.
Sites / Locations
- Hospital Maisonneuve Rosemont
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Tourniquet Group
Non-Tourniquet group
Arm Description
Tourniquet application during procedures
No application of tourniquet for procedures
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Operative time
time from beginning to end of surgery
Bleeding levels
3-point ordinal scale:
No bleeding
minor bleeding controlled with dabbing
bleeding requiring use of electrocautery
Peri-operative complication
Peri-operative complications including nerve or tendon damage
Post-operative complications
Hematoma, infection and wound dehiscence/breakdown
Full Information
NCT ID
NCT04354415
First Posted
April 15, 2020
Last Updated
May 21, 2020
Sponsor
Maisonneuve-Rosemont Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04354415
Brief Title
Tourniquet vs. No Tourniquet for Carpal Tunnel and Trigger Finger Release
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
October 25, 2018 (Actual)
Primary Completion Date
June 20, 2019 (Actual)
Study Completion Date
April 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maisonneuve-Rosemont Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome, Trigger Finger
Keywords
Tourniquet, WALANT, Patient-Centered
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tourniquet Group
Arm Type
Active Comparator
Arm Description
Tourniquet application during procedures
Arm Title
Non-Tourniquet group
Arm Type
Experimental
Arm Description
No application of tourniquet for procedures
Intervention Type
Procedure
Intervention Name(s)
Carpal tunnel or trigger finger release
Intervention Description
Carpal tunnel or trigger finger release with and without the use of tourniquet
Primary Outcome Measure Information:
Title
Peri-operative patient experience
Description
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
Time Frame
In the immediate post-operative period
Secondary Outcome Measure Information:
Title
Operative time
Description
time from beginning to end of surgery
Time Frame
Assessed in the immediate post-operative period
Title
Bleeding levels
Description
3-point ordinal scale:
No bleeding
minor bleeding controlled with dabbing
bleeding requiring use of electrocautery
Time Frame
Assessed peri-operatively and noted in the immediate post-operative period
Title
Peri-operative complication
Description
Peri-operative complications including nerve or tendon damage
Time Frame
In the immediate post-operative period
Title
Post-operative complications
Description
Hematoma, infection and wound dehiscence/breakdown
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
contra-indications for subcutaneous epinephrine use
history of digital gangrene
buerger's disease
previous replantation
Raynaud
Sclerodactyly.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique M Tremblay, MD
Organizational Affiliation
Université de Montréal (Hospital Maisonneuve-Rosemont)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Maisonneuve Rosemont
City
Montréal-Est
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Tourniquet vs. No Tourniquet for Carpal Tunnel and Trigger Finger Release
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