Carpal Tunnel SyndromeNCT06172400
Wide Awake Open Carpal Tunnel Release With or Without a Tourniquet
A study testing Mepivacaine, Combinations in people with Carpal Tunnel Syndrome, run by Region Skane.
Trial summary
The goal of this clinical trial is to compare open carpal tunnel release using local anesthesia with or without a tourniquet. The main questions it aims to answer are: 1. Do the tourniquet cause more procedural pain? 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Mepivacaine, Combinations
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 9 Jan 2024to 31 Dec 2025
- 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
- Primary idiopathic CTS
- Age 18 or older
- Symptoms of classic or probable carpal tunnel syndrome according to Katz hand diagram
- No previous wide awake hand surgical procedures under local anesthesia
- No planned concomitant procedures
Who cannot join
- Recurrent carpal tunnel syndrome
- Vibration induced neuropathy
- Polyneuropathy
- Cognitive impairment
- Anxiety disorder
- Swedish language insufficiency
Show all 9Show fewer
- Active substance abuse
- Allergy to local anesthesia or adrenaline
- Patient refusal to participate
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Wide Awake Open Carpal Tunnel Release With or Without a Tourniquet: a Randomized Single-blinded Controlled Trial
The goal of this clinical trial is to compare open carpal tunnel release using local anesthesia with or without a tourniquet. The main questions it aims to answer are:
- Do the tourniquet cause more procedural pain?
- Does the use of tourniquet affect the outcome after the procedure? Participants will be randomized to either local anesthesia with a tourniquet or local anesthesia with adrenaline, and undrgo standard open carpal tunnel release.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Mepivacaine, Combinations
- 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.
Mepivacaine, CombinationsDrug
Using local anesthesia with adrenaline for intraoperative vasoconstriction instead of a tourniquet.
| Study group | Role | What they receive |
|---|---|---|
| Touniquet | Active comparator | Local injection of Mepivacaine (10 mg/ml) approximately 10 ml in the incisional area at least 10 minutes before surgery start. Use of a forearm tourniquet at the pressure of 250 mmHg. Receives: Drug: Mepivacaine, Combinations |
| Adrenaline | Experimental | Local injection of Mepivacaine (10 mg/ml) and adrenaline (5 mcg/ml) approximately 10 ml in the incisional area at least 10 minutes before surgery start. Forearm tourniquet applied but not inflated. Receives: Drug: Mepivacaine, Combinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural pain
Visual analog scale 0 (no pain)-100 (worst possible pain)
Measured: Day 1
Secondary outcomes (8)
Injection pain
Visual analog scale 0 (no pain)-100 (worst possible pain)
Measured: Day 1
Procedure satisfaction
Visual analog scale 0 (best)-100 (worst)
Measured: Day 1
Surgery time
Incision to wound closure (minutes)
Measured: Day 1
Use of diathermy/need to inflate or deflate tourniquet
Measured: Day 1
Adverse events
Measured: 2 weeks
11-item disabilities of arm, shoulder and hand questionnaire (QuickDASH)
0 (best)-100 (worse)
Measured: 3 months, 1 year
Atroshi-Lyrén scale
1 (no symptoms)- 5 (worst symptoms)
Measured: 3 months, 1 year
Palmar pain scale
0 (no palmar pain or activity limitation)-100 (worst)
Measured: 3 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start9 Jan 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
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.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172400
- Sponsor's protocol ID
- 2020-04670
- Status last verified
- Dec 2023
- First submitted
- 7 Dec 2023
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wide Awake Open Carpal Tunnel Release With or Without a Tourniquet: a Randomized Single-blinded Controlled Trial
- ClinicalTrials.gov ID
- NCT06172400
- Acronym / sponsor ID
- 2020-04670
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 9 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Dec 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 goal of this clinical trial is to compare open carpal tunnel release using local anesthesia with or without a tourniquet. The main questions it aims to answer are:
- Do the tourniquet cause more procedural pain?
- Does the use of tourniquet affect the outcome after the procedure? Participants will be randomized to either local anesthesia with a tourniquet or local anesthesia with adrenaline, and undrgo standard open carpal tunnel release.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Touniquet | Active comparator | Drug: Mepivacaine, CombinationsLocal injection of Mepivacaine (10 mg/ml) approximately 10 ml in the incisional area at least 10 minutes before surgery start. Use of a forearm tourniquet at the pressure of 250 mmHg. |
| Adrenaline | Experimental | Drug: Mepivacaine, CombinationsLocal injection of Mepivacaine (10 mg/ml) and adrenaline (5 mcg/ml) approximately 10 ml in the incisional area at least 10 minutes before surgery start. Forearm tourniquet applied but not inflated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary idiopathic CTS
- Age 18 or older
- Symptoms of classic or probable carpal tunnel syndrome according to Katz hand diagram
- No previous wide awake hand surgical procedures under local anesthesia
- No planned concomitant procedures
Key exclusion criteria (9 listed)
- Recurrent carpal tunnel syndrome
- Vibration induced neuropathy
- Polyneuropathy
- Cognitive impairment
- Anxiety disorder
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 |
|---|---|---|
| Mepivacaine, CombinationsUsing local anesthesia with adrenaline for intraoperative vasoconstriction instead of a tourniquet. | Drug | Adrenaline, Touniquet |
Primary outcome
Procedural pain
Time frame: Day 1
Visual analog scale 0 (no pain)-100 (worst possible pain)
8 secondary outcomes
Injection pain
Time frame: Day 1
Procedure satisfaction
Time frame: Day 1
Surgery time
Time frame: Day 1
Use of diathermy/need to inflate or deflate tourniquet
Time frame: Day 1
Adverse events
Time frame: 2 weeks
11-item disabilities of arm, shoulder and hand questionnaire (QuickDASH)
Time frame: 3 months, 1 year
Atroshi-Lyrén scale
Time frame: 3 months, 1 year
Palmar pain scale
Time frame: 3 months, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 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.
Questions about this trial
What is this clinical trial studying?
A study testing Mepivacaine, Combinations in people with Carpal Tunnel Syndrome, run by Region Skane.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jesper Nordenskjöld, MD, PhD (0739706570, jesper.nordenskjold@skane.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural pain (time frame: Day 1). 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 Dec 2023.