Carpal Tunnel Syndrome Clinical Trial
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
Verified date | May 2020 |
Source | Maisonneuve-Rosemont Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 67 |
Est. completion date | April 6, 2020 |
Est. primary completion date | June 20, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Canada | Hospital Maisonneuve Rosemont | Montréal-Est | Quebec |
Lead Sponsor | Collaborator |
---|---|
Maisonneuve-Rosemont Hospital |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Operative time | time from beginning to end of surgery | Assessed in the immediate post-operative period | |
Secondary | 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 | |
Secondary | Peri-operative complication | Peri-operative complications including nerve or tendon damage | In the immediate post-operative period | |
Secondary | Post-operative complications | Hematoma, infection and wound dehiscence/breakdown | 1 week |
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