Carpal Tunnel SyndromeNCT04354415
Tourniquet vs. No Tourniquet for Carpal Tunnel and Trigger Finger Release
A study testing Carpal tunnel or trigger finger release in people with Carpal Tunnel Syndrome and Trigger Finger, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome, Trigger Finger
- What is being tested?
- Carpal tunnel or trigger finger release
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteCanada
- Study dates
- 25 Oct 2018to 6 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- contra-indications for subcutaneous epinephrine use
- history of digital gangrene
- buerger's disease
- previous replantation
- Raynaud
- Sclerodactyly.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Carpal tunnel or trigger finger release
- Keywords
- Tourniquet, WALANT, Patient-Centered
- Medical subject headings
- Carpal Tunnel Syndrome, Trigger Finger Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carpal tunnel or trigger finger releaseProcedure or surgery
Carpal tunnel or trigger finger release with and without the use of tourniquet
| Study group | Role | What they receive |
|---|---|---|
| Tourniquet Group | Active comparator | Tourniquet application during procedures Receives: Procedure: Carpal tunnel or trigger finger release |
| Non-Tourniquet group | Experimental | No application of tourniquet for procedures Receives: Procedure: Carpal tunnel or trigger finger release |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: In the immediate post-operative period
Secondary outcomes (4)
Operative time
time from beginning to end of surgery
Measured: 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
Measured: Assessed peri-operatively and noted in the immediate post-operative period
Peri-operative complication
Peri-operative complications including nerve or tendon damage
Measured: In the immediate post-operative period
Post-operative complications
Hematoma, infection and wound dehiscence/breakdown
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start25 Oct 2018
- Primary completion20 Jun 2019
- Study completion6 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eli Saleh, Maisonneuve-Rosemont Hospital
- Investigators
- Dominique M Tremblay, MD, Principal investigator, Université de Montréal (Hospital Maisonneuve-Rosemont)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354415
- Sponsor's protocol ID
- CER-CEMTL(6518)
- Status last verified
- May 2020
- First submitted
- 15 Apr 2020
- Last updated
- 26 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04354415
- Acronym / sponsor ID
- CER-CEMTL(6518)
- Conditions
- Carpal Tunnel Syndrome, Trigger Finger
- Keywords
- Tourniquet, WALANT, Patient-Centered
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 6 Apr 2020 (actual)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tourniquet Group | Active comparator | Procedure: Carpal tunnel or trigger finger releaseTourniquet application during procedures |
| Non-Tourniquet group | Experimental | Procedure: Carpal tunnel or trigger finger releaseNo application of tourniquet for procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- contra-indications for subcutaneous epinephrine use
- history of digital gangrene
- buerger's disease
- previous replantation
- Raynaud
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carpal tunnel or trigger finger releaseCarpal tunnel or trigger finger release with and without the use of tourniquet | Procedure or surgery | Non-Tourniquet group, Tourniquet Group |
Primary outcome
Peri-operative patient experience
Time frame: In the immediate post-operative period
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
4 secondary outcomes
Operative time
Time frame: Assessed in the immediate post-operative period
Bleeding levels
Time frame: Assessed peri-operatively and noted in the immediate post-operative period
Peri-operative complication
Time frame: In the immediate post-operative period
Post-operative complications
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique M Tremblay, MD principal investigator
Université de Montréal (Hospital Maisonneuve-Rosemont)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carpal tunnel or trigger finger release in people with Carpal Tunnel Syndrome and Trigger Finger, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-operative patient experience (time frame: In the immediate post-operative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2020.