Carpal Tunnel SyndromeNCT04453462
Efficacy of Local Direct Median Nerve Block
A study testing Endoscopic carpal tunnel release under local direct median nerve block and Endoscopic carpal tunnel release under brachial plexus block in people with Carpal Tunnel Syndrome and Anesthesia, Local, run by Thammasat University at 1 site in Thailand.
Trial summary
Carpal tunnel syndrome is the most common compressive neuropathy. Carpal tunnel release is indicated when failed conservative treatment. Although it can be done either with local anesthesia or brachial plexus block, there is no gold standard of anesthetic choice. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carpal Tunnel Syndrome, Anesthesia, Local
- What is being tested?
- Endoscopic carpal tunnel release under local direct median nerve block and Endoscopic carpal tunnel release under brachial plexus block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2018to 1 Sep 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with carpal tunnel syndrome, confirmed by EMG
- Failed conservative treatment 3 months
- Age ≥18 years old
Who cannot join
- Allergic history of xylocaine
- Any other condition that can cause carpal tunnel syndrome or peripheral neuropathy e.g. DM, hypothyroidism, pregnancy, tumor
- Any patient that has been coverted to open carpal tunnel release
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Thammasat University hospital
Khlong Luang, Changwat Pathum Thani, 12120
About this study
Official title: Efficacy of Local Direct Median Nerve Block VS Brachial Plexus Block in Endoscopic Carpal Tunnel Release
Carpal tunnel syndrome is the most common compressive neuropathy. Carpal tunnel release is indicated when failed conservative treatment. Although it can be done either with local anesthesia or brachial plexus block, there is no gold standard of anesthetic choice. The study is conducted to compare the efficacy of two methods and we hypothesized that the local direct median nerve block has effectiveness in intraoperative pain control not inferior to brachial plexus block in endoscopic carpal tunnel release.
Read the detailed description
The study is randomized-control trial conducted in single center (Orthopaedic department, Faculty of medicine, Thammasat university) The patients with failed conservative treatment of carpal tunnel syndrome confirmed by EMG are enrolled and ramdomized with computerized block-of-4 method.The local direct median nerve block is done by the surgeon and brachial plexus block in done by single anesthesiologist after that the patient will be operated with 1-portal endoscopic carpal tunnel release (Agee technque) by single surgeon. Immediate postoperative the blinded observer will ask the patient about interaoperative pain in visual analog scale then the pateint is asked to record the 2-hr, 4-hr ,6-hr and 12-hr postoperative pain in case record form.The patient will return the case record form at 2-week and also stitched off the wound then next follow up will be 4, 12, 24 weeks to assess functional outcome (Thai version Bonton questionaire)
- Conditions
- Carpal Tunnel Syndrome, Anesthesia, Local
- Being tested
- Endoscopic carpal tunnel release under local direct median nerve block, Endoscopic carpal tunnel release under brachial plexus block
- Keywords
- Endoscopic carpal tunnel release
- 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.
Endoscopic carpal tunnel release under local direct median nerve blockProcedure or surgery
local direct median nerve block is performed by surgeon using the 1%xylocaine with adrenaline 12 mL(5 mL subcutaneous at incision site and 7 mL over median nerve) (maximum dose 7 mg/kg) before the endoscopic carpal tunnel release(1-portal Agee technique)
Endoscopic carpal tunnel release under brachial plexus blockProcedure or surgery
brachial plexus block under ultrasound-guided is performed by experienced single anesthesiologist using the 1%xylocaine with adrenaline 15 mL (maximum dose 7 mg/kg) before the endoscopic carpal tunnel release(1-portal Agee technique)
| Study group | Role | What they receive |
|---|---|---|
| Local direct median nerve block | Active comparator | The local anesthetic technique is proposed by Wood SH and Logan AM in 1999 by using the plastic catheter to inject the anesthetic 4 cm proximally to the incision site direct over the median and ulna nerve Receives: Procedure: Endoscopic carpal tunnel release under local direct median nerve block |
| Brachial plexus block | Active comparator | The brachial plexus block technique is axillary block performed under ultrasound-guided by the well-trained anesthesiologist. Receives: Procedure: Endoscopic carpal tunnel release under brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative pain measured as visual analog scale (VAS)
Visual analog scale (VAS) from 0-10 0 means no pain 5 means moderate pain 10 means worst possible pain
Immediate postoperative the blinded observer will ask the patient about interaoperative pain in visual analog scale
Measured: Immediate postoperative period
Secondary outcomes (2)
Postoperative pain measured as visual analog scale (VAS)
Visual analog scale (VAS) from 0-10 0 means no pain 5 means moderate pain 10 means worst possible pain
The pateint is asked to record the 2 hours, 4 hours, 6 hours and 12 hours postoperative pain in case record form.
Measured: 2 hours, 4 hours, 6 hours and 12 hours postoperative period
Functional outcome of the hand measured as Thai Version Boston Questionnaire
There are 2 parts of Thai Version Boston Questionnaire
- Symptom severity scores (SSS) 11 items (total score 0-55; hign score means worse outcome)
- Functional severity scores (FSS) 8 items (total score 0-40; hign score means worse outcome)
The follow up will be 1, 4, 12, 24 weeks to assess functional outcome with Thai Version Boston Questionnaire
Measured: 2, 4, 12, 24 weeks postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start1 May 2018
- Primary completion1 Feb 2021
- Study completion1 Sep 2021
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kittipong Siriboonpipattana, Thammasat University
- Investigators
- Chinnakart Boonyasirikool, MD, Principal investigator, Department of Orthopaedics, Faculty of Medicine Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453462
- Sponsor's protocol ID
- MTU-EC-OT-6-227/61
- Status last verified
- Apr 2023
- First submitted
- 26 Jun 2020
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Local Direct Median Nerve Block VS Brachial Plexus Block in Endoscopic Carpal Tunnel Release
- ClinicalTrials.gov ID
- NCT04453462
- Acronym / sponsor ID
- MTU-EC-OT-6-227/61
- Conditions
- Carpal Tunnel Syndrome, Anesthesia, Local
- Keywords
- Endoscopic carpal tunnel release
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 1 Jul 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.
Carpal tunnel syndrome is the most common compressive neuropathy. Carpal tunnel release is indicated when failed conservative treatment. Although it can be done either with local anesthesia or brachial plexus block, there is no gold standard of anesthetic choice. The study is conducted to compare the efficacy of two methods and we hypothesized that the local direct median nerve block has effectiveness in intraoperative pain control not inferior to brachial plexus block in endoscopic carpal tunnel release.
Detailed description
The study is randomized-control trial conducted in single center (Orthopaedic department, Faculty of medicine, Thammasat university) The patients with failed conservative treatment of carpal tunnel syndrome confirmed by EMG are enrolled and ramdomized with computerized block-of-4 method.The local direct median nerve block is done by the surgeon and brachial plexus block in done by single anesthesiologist after that the patient will be operated with 1-portal endoscopic carpal tunnel release (Agee technque) by single surgeon. Immediate postoperative the blinded observer will ask the patient about interaoperative pain in visual analog scale then the pateint is asked to record the 2-hr, 4-hr ,6-hr and 12-hr postoperative pain in case record form.The patient will return the case record form at 2-week and also stitched off the wound then next follow up will be 4, 12, 24 weeks to assess functional outcome (Thai version Bonton questionaire)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local direct median nerve block | Active comparator | Procedure: Endoscopic carpal tunnel release under local direct median nerve blockThe local anesthetic technique is proposed by Wood SH and Logan AM in 1999 by using the plastic catheter to inject the anesthetic 4 cm proximally to the incision site direct over the median and ulna nerve |
| Brachial plexus block | Active comparator | Procedure: Endoscopic carpal tunnel release under brachial plexus blockThe brachial plexus block technique is axillary block performed under ultrasound-guided by the well-trained anesthesiologist. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with carpal tunnel syndrome, confirmed by EMG
- Failed conservative treatment 3 months
- Age ≥18 years old
Key exclusion criteria (3 listed)
- Allergic history of xylocaine
- Any other condition that can cause carpal tunnel syndrome or peripheral neuropathy e.g. DM, hypothyroidism, pregnancy, tumor
- Any patient that has been coverted to open carpal tunnel release
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 |
|---|---|---|
| Endoscopic carpal tunnel release under local direct median nerve blocklocal direct median nerve block is performed by surgeon using the 1%xylocaine with adrenaline 12 mL(5 mL subcutaneous at incision site and 7 mL over median nerve) (maximum dose 7 mg/kg) before the endoscopic carpal tunnel release(1-portal Agee technique) | Procedure or surgery | Local direct median nerve block |
| Endoscopic carpal tunnel release under brachial plexus blockbrachial plexus block under ultrasound-guided is performed by experienced single anesthesiologist using the 1%xylocaine with adrenaline 15 mL (maximum dose 7 mg/kg) before the endoscopic carpal tunnel release(1-portal Agee technique) | Procedure or surgery | Brachial plexus block |
Primary outcome
Intraoperative pain measured as visual analog scale (VAS)
Time frame: Immediate postoperative period
Visual analog scale (VAS) from 0-10 0 means no pain 5 means moderate pain 10 means worst possible pain Immediate postoperative the blinded observer will ask the patient about interaoperative pain in visual analog scale
2 secondary outcomes
Postoperative pain measured as visual analog scale (VAS)
Time frame: 2 hours, 4 hours, 6 hours and 12 hours postoperative period
Functional outcome of the hand measured as Thai Version Boston Questionnaire
Time frame: 2, 4, 12, 24 weeks postoperative period
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 3 May 2023.
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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.
Chinnakart Boonyasirikool, MD principal investigator
Department of Orthopaedics, Faculty of Medicine Thammasat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic carpal tunnel release under local direct median nerve block and Endoscopic carpal tunnel release under brachial plexus block in people with Carpal Tunnel Syndrome and Anesthesia, Local, run by Thammasat University at 1 site in Thailand.
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 3 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 3 May 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 Thailand. 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?
Intraoperative pain measured as visual analog scale (VAS) (time frame: Immediate postoperative 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 3 May 2023.