Carpal Tunnel SyndromeNCT05747846
Pain in Carpal Tunnel Release Wide-awake Local Anesthesia With no Tourniquet vs Local Anesthesia With Tourniquet
A study testing Carpal tunnel release, WALANT technique and Carpal tunnel release using a tourniquet in people with Carpal Tunnel Syndrome, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
The aim of this study is to compare pain, satisfaction, and experience between patients who underwent Carpal Tunnel Release with wide-awake local anesthesia no tourniquet technique and local anesthesia with a tourniquet. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Carpal tunnel release, WALANT technique and Carpal tunnel release using a tourniquet
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteArgentina
- Study dates
- 15 Dec 2020to 26 Aug 2023
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Carpal tunnel syndrome with surgical resolution
- Surgical procedures takes less than 30 minutes
Who cannot join
- Lost follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Pain in Carpal Tunnel Release Wide-awake Local Anesthesia With no Tourniquet vs Local Anesthesia With Tourniquet
The aim of this study is to compare pain, satisfaction, and experience between patients who underwent Carpal Tunnel Release with wide-awake local anesthesia no tourniquet technique and local anesthesia with a tourniquet.
Read the detailed description
The surgical pathology of the hand has grown exponentially. In most cases, the resolution is performed in outpatients with short surgical times. Given the increased demand for this type of surgery, surgeons have sought different variables to reduce the costs and human resources. Thus, the wide-awake local anesthesia no tourniquet procedure (WALANT). It deals with the non-need for anesthetic monitoring and with the regional use of anesthesia with epinephrine.
Its use avoids placing a pneumatic cuff on the arm owing to the vasoconstrictive action of epinephrine. However, the drug takes 25-30 minutes to achieve the maximum hemostatic effect, and adverse effects, such as distal necrosis, have been reported.
Therefore, the technique of local anesthesia without epinephrine with a tourniquet (LA-T) is also used daily by hand surgeons.
The use of a tourniquet, a pneumatic cuff, for less than 20 minutes has been associated with the same or lower pain profiles than the wide-awake local anesthesia no tourniquet without running the risk of adverse effects of epinephrine.
The objective of this study is to compare and assess pain and patient experience after short-duration hand surgery using the WALANT and LA-T techniques. The investigators hypothesized that both types of procedures had a similar level of satisfaction.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Carpal tunnel release, WALANT technique, Carpal tunnel release using a tourniquet
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carpal tunnel release, WALANT techniqueProcedure or surgery
Patients will receive 20 ml of 1% lidocaine with 1:100,000 epinephrine (buffered 10:1 with 8.4% sodium bicarbonate). Thirty minutes before carpal tunnel release surgery, 10 mL will be injected subcutaneously, and 10 mL will be injected into the carpal tunnel. Patients will go under open carpal tunnel release without a tourniquet.
Carpal tunnel release using a tourniquetProcedure or surgery
Patients will receive 20 ml of 1% lidocaine with 1:100,000 epinephrine (buffered 10:1 with 8.4% sodium bicarbonate). Thirty minutes before carpal tunnel release surgery, 10 mL will be injected subcutaneously, and 10 mL will be injected into the carpal tunnel. Patients will go under open carpal tunnel release using a hemostatic cuff. The hemostatic cuff will be insufflated at the level of the arm at a pressure of 100 mmHg higher than the patient's systolic pressure. The cuff will be removed once wound closure is complete.
| Study group | Role | What they receive |
|---|---|---|
| wide-awake local anesthesia no tourniquet | Active comparator | Patients will be operated under local anesthesia without a tourniquet (WALANT technique) Receives: Procedure: Carpal tunnel release, WALANT technique |
| Tourniquet | Active comparator | Patients will be operated under local anesthesia with the use of a tourniquet Receives: Procedure: Carpal tunnel release using a tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during surgery
Visual analog scale. A numerical scale from 0 to 10 (a higher score means the worst outcome), where 0 indicates no pain, and 10 indicates the worst pain possible.
Measured: Immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start15 Dec 2020
- Primary completion7 Aug 2023
- Study completion26 Aug 2023
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, IGNACIO RELLAN, Hospital Italiano de Buenos Aires
- Investigators
- Nicolas M Molho, MD, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747846
- Sponsor's protocol ID
- 5857
- Status last verified
- Aug 2023
- First submitted
- 25 Jan 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- 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 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Pain in Carpal Tunnel Release Wide-awake Local Anesthesia With no Tourniquet vs Local Anesthesia With Tourniquet
- ClinicalTrials.gov ID
- NCT05747846
- Acronym / sponsor ID
- 5857
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 7 Aug 2023 (actual)
- Study completion
- 26 Aug 2023 (actual)
- First posted
- 28 Feb 2023 (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.
The aim of this study is to compare pain, satisfaction, and experience between patients who underwent Carpal Tunnel Release with wide-awake local anesthesia no tourniquet technique and local anesthesia with a tourniquet.
Detailed description
The surgical pathology of the hand has grown exponentially. In most cases, the resolution is performed in outpatients with short surgical times. Given the increased demand for this type of surgery, surgeons have sought different variables to reduce the costs and human resources. Thus, the wide-awake local anesthesia no tourniquet procedure (WALANT). It deals with the non-need for anesthetic monitoring and with the regional use of anesthesia with epinephrine.
Its use avoids placing a pneumatic cuff on the arm owing to the vasoconstrictive action of epinephrine. However, the drug takes 25-30 minutes to achieve the maximum hemostatic effect, and adverse effects, such as distal necrosis, have been reported.
Therefore, the technique of local anesthesia without epinephrine with a tourniquet (LA-T) is also used daily by hand surgeons.
The use of a tourniquet, a pneumatic cuff, for less than 20 minutes has been associated with the same or lower pain profiles than the wide-awake local anesthesia no tourniquet without running the risk of adverse effects of epinephrine.
The objective of this study is to compare and assess pain and patient experience after short-duration hand surgery using the WALANT and LA-T techniques. The investigators hypothesized that both types of procedures had a similar level of satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| wide-awake local anesthesia no tourniquet | Active comparator | Procedure: Carpal tunnel release, WALANT techniquePatients will be operated under local anesthesia without a tourniquet (WALANT technique) |
| Tourniquet | Active comparator | Procedure: Carpal tunnel release using a tourniquetPatients will be operated under local anesthesia with the use of a tourniquet |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Carpal tunnel syndrome with surgical resolution
- Surgical procedures takes less than 30 minutes
Key exclusion criteria (1 listed)
- Lost follow-up
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 release, WALANT techniquePatients will receive 20 ml of 1% lidocaine with 1:100,000 epinephrine (buffered 10:1 with 8.4% sodium bicarbonate). Thirty minutes before carpal tunnel release surgery, 10 mL will be injected subcutaneously, and 10 mL will be injected into the carpal tunnel. Patients will go under open carpal tunnel release without a tourniquet. | Procedure or surgery | wide-awake local anesthesia no tourniquet |
| Carpal tunnel release using a tourniquetPatients will receive 20 ml of 1% lidocaine with 1:100,000 epinephrine (buffered 10:1 with 8.4% sodium bicarbonate). Thirty minutes before carpal tunnel release surgery, 10 mL will be injected subcutaneously, and 10 mL will be injected into the carpal tunnel. Patients will go under open carpal tunnel release using a hemostatic cuff. The hemostatic cuff will be insufflated at the level of the arm at a pressure of 100 mmHg higher than the patient's systolic pressure. The cuff will be removed once wound closure is complete. | Procedure or surgery | Tourniquet |
Primary outcome
Pain during surgery
Time frame: Immediately after surgery
Visual analog scale. A numerical scale from 0 to 10 (a higher score means the worst outcome), where 0 indicates no pain, and 10 indicates the worst pain possible.
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 29 Aug 2023.
- 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.
Nicolas M Molho, MD principal investigator
Hospital Italiano de Buenos Aires
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 release, WALANT technique and Carpal tunnel release using a tourniquet in people with Carpal Tunnel Syndrome, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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 2 inclusion and 1 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 29 Aug 2023. 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 Argentina. 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?
Pain during surgery (time frame: Immediately after surgery). 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 29 Aug 2023.