Carpal Tunnel SyndromePERSONNELNCT05372393
Carpal Tunnel Release Under Local Anaesthesia With or Without Distal Median Nerve Block
A study testing Local infiltration anaesthesia in carpal tunnel release and Distal median nerve block with local infiltration anaesthesia in carpal tunnel release in people with Carpal Tunnel Syndrome, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
Carpal tunnel syndrome (CTS) is the most commonly appearing entrapment neuropathy of the upper extremity. Treatment options include both non-operative and operative methods. Surgical treatment, carpal tunnel release (CTR), involves division of the transverse carpal ligament. 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?
- Local infiltration anaesthesia in carpal tunnel release and Distal median nerve block with local infiltration anaesthesia in carpal tunnel release
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteFinland
- Study dates
- 21 Sep 2022to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- ≥18 years of age
- CTS verified by nerve conduction studies
- Symptoms suitable for CTS
Who cannot join
- Recurrent CTS
- Peripheral neuropathies
- Known allergy to the trial drugs
- Profound cognitive impairment
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Kuopio University hospital, Department of Orthopaedics, Traumatology and Hand Surgery
Kuopio, Northern Savonia, 70210
Yrjänä Nietosvaara, Prof., +358447176883, yrjana.nietosvaara@pshyvinvointialue.fi
Noora Heikkinen
About this study
Official title: Carpal Tunnel Release Under Local Anaesthesia With or Without Distal Median Nerve Block - a Protocol of a Double Blinded Randomised Controlled Trial
Carpal tunnel syndrome (CTS) is the most commonly appearing entrapment neuropathy of the upper extremity. Treatment options include both non-operative and operative methods. Surgical treatment, carpal tunnel release (CTR), involves division of the transverse carpal ligament. Surgery can be performed under axillary or intravenous block, or general anaesthesia. There are no prior randomised controlled trials (RCT) comparing local infiltration anaesthesia to local infiltration anaesthesia augmented with a distal median nerve block in CTR.
The aim of this trial is to investigate whether adding a distal median nerve block to local anaesthesia reduces the patient's perceived pain level for up to 72 hours after CTR, compared to using only local anaesthesia, i.e., an anaesthesia mixture injected solely in and around the planned incision and nerve release. The null hypothesis is that the use of distal median nerve block with local anaesthesia does not reduce pain after CTR compared to pure local anaesthesia.
Read more
PERSONNEL (carPal tunnEl ReleaSe lOcal iNfiltratioN mEdian bLockade) is a double-blinded, i.e., patient and investigators, RCT in patients with CTS. Patients will be randomly divided into two parallel trial groups, 1:1 in size to each other. Fifty-nine patients will be needed for each group to have adequate power. The primary outcome is the pain level perceived by the patient after the procedure during the first 72 hours using the Visual Analogue Scale (VAS). Secondary outcomes include patient-rated outcome measures, safety, the entire consumption of pain killers after the surgery during the first 72 hours postoperatively, pain of performing the anaesthesia, and pain during and after the operation.
No trial comparing local anaesthesia to local anaesthesia augmented with distal median nerve block has been published before. There is also no trial noting individual tolerance to pain. The quality of the median nerve block at the wrist has been achieved by using sensory or sensory-motor nerve stimulation and has been proven effective. This increases trust in the effectiveness of the treatment method, but it still needs to be adequately proven which is the goal of this trial.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Local infiltration anaesthesia in carpal tunnel release, Distal median nerve block with local infiltration anaesthesia in carpal tunnel release
- Keywords
- carpal tunnel syndrome, carpal tunnel release, local anaesthesia, surgery, wide-awake local anaesthesia with no tourniquet, nerve block
- 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.
Local infiltration anaesthesia in carpal tunnel releaseProcedure or surgery
The anaesthetic cocktail consists of 1 ml of (7.5%) sodium bicarbonate (Natriumbicarbonate Braun 75mg/ml), 4,5 ml of lidocaine with adrenaline 1% (Lidocain cum adrenalin 10 mg/ml), 4,5 ml of bupivacaine with adrenaline 0.5% (Marcain cum adrenalin 5mg/ml +5 µg/ml). The anaesthetic cocktail must be prepared in the above-mentioned order to avoid possible precipitation. A 24-gauge hypodermic needle and 10 ml syringe are used to inject the solution. The care provider pinches from the area of median nerve blockade prior to performing local anaesthesia. All the anaesthetic solution is injected locally. Additional anaesthetic solution can be injected locally if necessary.
Distal median nerve block with local infiltration anaesthesia in carpal tunnel releaseProcedure or surgery
The anaesthetic cocktail consists of 1 ml of (7.5%) sodium bicarbonate (Natriumbicarbonate Braun 75mg/ml), 4,5 ml of lidocaine with adrenaline 1% (Lidocain cum adrenalin 10 mg/ml), 4,5 ml of bupivacaine with adrenaline 0.5% (Marcain cum adrenalin 5mg/ml +5 µg/ml). The anaesthetic cocktail must be prepared in the above-mentioned order to avoid possible precipitation. A 24-gauge hypodermic needle and 10 ml syringe are used to inject the solution. Half of the anaesthetic solution is injected into the median nerve area 5-7 cm proximally from the distal wrist crease. The other half is injected locally. Additional anaesthetic solution can be injected locally if necessary.
| Study group | Role | What they receive |
|---|---|---|
| Local infiltration anaesthesia in carpal tunnel release | Active comparator | The investigators allocate 59 patients in this arm. It serves as the control group, who receives local infiltration anaesthesia. Receives: Procedure: Local infiltration anaesthesia in carpal tunnel release |
| Distal median nerve block with local infiltration anaesthesia in carpal tunnel release | Experimental | The investigators allocate 59 patients in this arm. It serves as the experimental group, who receives local infiltration anaesthesia and distal median nerve block. Receives: Procedure: Distal median nerve block with local infiltration anaesthesia in carpal tunnel release |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pain level perceived by the patient after the procedure using Visual Analogue Scale (VAS)
The investigators measure the pain level perceived by the patient after the procedure every fourth hour while awake until third night postoperatively using VAS. The first assessment is performed four hours after the surgery. The mean VAS is calculated from all time points over the 72-hour period. The Visual analogue Scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable.
Measured: Postoperatively during the first 72 hours after the operation
Secondary outcomes (12)
Pressure pain (VAS)
The investigators ask the patients to evaluate the pressure pain that the infiltration of the anaesthetic solution caused using Visual Analogue Scale (VAS). The Visual Analogue Scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable.
Measured: Immediately after the infiltration of anaesthetic solution
Burning pain (VAS)
The investigators ask the patients to evaluate the burning pain that the infiltration of the anaesthetic solution caused using Visual Analogue Scale (VAS). The Visual Analogue Scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable.
Measured: Immediately after the infiltration of anaesthetic solution
Needle sting pain (VAS)
The investigators ask the patients to evaluate the needle sting pain that the infiltration of the anaesthetic solution caused using Visual Analogue Scale (VAS). The Visual Analogue Scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable.
Measured: Immediately after the infiltration of anaesthetic solution
Total pain during the injection of the anaesthetic solution (VAS)
The investigators ask the patients to evaluate the total pain that the infiltration of the anaesthetic solution caused using Visual Analogue Scale (VAS). The Visual Analogue Scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable.
Measured: Immediately after the infiltration of anaesthetic solution
Worst pain during the operation (VAS)
The investigators ask the patients to evaluate the worst pain during the operation using Visual Analogue Scale (VAS). The Visual Analogue Scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable.
Measured: Immediately after the operation
Duration of anaesthesia
The investigators assess the length of the anaesthesia by asking the patients to fill an online form when they first time feel pain in the operation field or have to use pain killers.
Measured: Postoperatively during the first 72 hours after the operation
Self-reported symptom severity and functional status
The investigators ask the patients to evaluate their symptoms using Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) score. It consists of the Symptom Severity Scale (SSS) containing 11 questions, and it uses a five-point Likert rating scale from 1 (no symptoms) to 5 (most severe symptoms), and Functional Status Scale (FSS), which has 8 questions assessing the degree of complaints on a five-point Likert scale from 1 (no symptoms) to 5 (most severe symptoms). Mean sum scores of both scales are calculated and used for analysis.
Measured: Before and 3 months postoperatively
Patient satisfaction
Patients evaluate how likely they would recommend the procedure to a fellow man using Net Promoter Score (NPS). Net Promoter Score is a measurement taken from asking patients how likely they are to recommend the procedure to others on a scale of 0-10. The higher score the better outcome.
Measured: 3 months postoperatively
Adverse events (AE)
Health care professional assessment
Measured: 3 months postoperatively
Expected pain (VAS)
The investigators ask the patient to evaluate the pain during the infiltration of the anaestetic solution using Visual Analogue Scale (VAS). The Visual Analogue Scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable.
Measured: Before the infiltration of the anaesthetic solution
Amount of perceived needle stings
The investigators ask the patient to report how many needle stings they felt when the anaesthesia was performed.
Measured: Immediately after the infiltration of anaesthetic solution
Consumption of pain killers
The investigators record the consumption of pain killers after surgery
Measured: Postoperatively during the first 72 hours after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start21 Sep 2022
- Primary completionDec 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- 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
- Two concurrent study groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Eastern Finland
- Responsible party
- Sponsor
- Investigators
- Yrjänä Nietosvaara, Prof., Study director, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372393
- Sponsor's protocol ID
- KUH5203140
- Acronym
- PERSONNEL
- Status last verified
- Sep 2025
- First submitted
- 9 May 2022
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This trial will share data with researchers who submit a methodologically sound proposal after its completion, as well as with reviewers of the journal where the trial results will be published, if necessary.
Publications
Shi Q, MacDermid JC. Is surgical intervention more effective than non-surgical treatment for carpal tunnel syndrome? A systematic review. J Orthop Surg Res. 2011 Apr 11;6:17. doi: 10.1186/1749-799X-6-17.
PubMed 21477381Piazzini DB, Aprile I, Ferrara PE, Bertolini C, Tonali P, Maggi L, Rabini A, Piantelli S, Padua L. A systematic review of conservative treatment of carpal tunnel syndrome. Clin Rehabil. 2007 Apr;21(4):299-314. doi: 10.1177/0269215507077294.
PubMed 17613571Keir PJ, Rempel DM. Pathomechanics of peripheral nerve loading. Evidence in carpal tunnel syndrome. J Hand Ther. 2005 Apr-Jun;18(2):259-69. doi: 10.1197/j.jht.2005.02.001.
PubMed 15891983Kozak A, Schedlbauer G, Wirth T, Euler U, Westermann C, Nienhaus A. Association between work-related biomechanical risk factors and the occurrence of carpal tunnel syndrome: an overview of systematic reviews and a meta-analysis of current research. BMC Musculoskelet Disord. 2015 Sep 1;16:231. doi: 10.1186/s12891-015-0685-0.
PubMed 26323649Padua L, Di Pasquale A, Pazzaglia C, Liotta GA, Librante A, Mondelli M. Systematic review of pregnancy-related carpal tunnel syndrome. Muscle Nerve. 2010 Nov;42(5):697-702. doi: 10.1002/mus.21910.
PubMed 20976778Mondelli M, Giannini F, Giacchi M. Carpal tunnel syndrome incidence in a general population. Neurology. 2002 Jan 22;58(2):289-94. doi: 10.1212/wnl.58.2.289.
PubMed 11805259Shiri R, Pourmemari MH, Falah-Hassani K, Viikari-Juntura E. The effect of excess body mass on the risk of carpal tunnel syndrome: a meta-analysis of 58 studies. Obes Rev. 2015 Dec;16(12):1094-104. doi: 10.1111/obr.12324. Epub 2015 Sep 23.
PubMed 26395787Shiri R. Hypothyroidism and carpal tunnel syndrome: a meta-analysis. Muscle Nerve. 2014 Dec;50(6):879-83. doi: 10.1002/mus.24453. Epub 2014 Oct 30.
PubMed 25204641Pourmemari MH, Shiri R. Diabetes as a risk factor for carpal tunnel syndrome: a systematic review and meta-analysis. Diabet Med. 2016 Jan;33(1):10-6. doi: 10.1111/dme.12855. Epub 2015 Aug 18.
PubMed 26173490Chammas M, Boretto J, Burmann LM, Ramos RM, Dos Santos Neto FC, Silva JB. Carpal tunnel syndrome - Part I (anatomy, physiology, etiology and diagnosis). Rev Bras Ortop. 2014 Aug 20;49(5):429-36. doi: 10.1016/j.rboe.2014.08.001. eCollection 2014 Sep-Oct.
PubMed 26229841Genova A, Dix O, Saefan A, Thakur M, Hassan A. Carpal Tunnel Syndrome: A Review of Literature. Cureus. 2020 Mar 19;12(3):e7333. doi: 10.7759/cureus.7333.
PubMed 32313774Kim PT, Lee HJ, Kim TG, Jeon IH. Current approaches for carpal tunnel syndrome. Clin Orthop Surg. 2014 Sep;6(3):253-7. doi: 10.4055/cios.2014.6.3.253. Epub 2014 Aug 5.
PubMed 25177448Wang L. Guiding Treatment for Carpal Tunnel Syndrome. Phys Med Rehabil Clin N Am. 2018 Nov;29(4):751-760. doi: 10.1016/j.pmr.2018.06.009. Epub 2018 Sep 17.
PubMed 30293628Padua L, Coraci D, Erra C, Pazzaglia C, Paolasso I, Loreti C, Caliandro P, Hobson-Webb LD. Carpal tunnel syndrome: clinical features, diagnosis, and management. Lancet Neurol. 2016 Nov;15(12):1273-1284. doi: 10.1016/S1474-4422(16)30231-9. Epub 2016 Oct 11.
PubMed 27751557Wipperman J, Goerl K. Carpal Tunnel Syndrome: Diagnosis and Management. Am Fam Physician. 2016 Dec 15;94(12):993-999.
PubMed 28075090
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carpal Tunnel Release Under Local Anaesthesia With or Without Distal Median Nerve Block - a Protocol of a Double Blinded Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05372393
- Acronym / sponsor ID
- PERSONNEL / KUH5203140
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- carpal tunnel syndrome, carpal tunnel release, local anaesthesia, surgery, wide-awake local anaesthesia with no tourniquet, nerve block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- University of Eastern Finland
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 12 May 2022 (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 (CTS) is the most commonly appearing entrapment neuropathy of the upper extremity. Treatment options include both non-operative and operative methods. Surgical treatment, carpal tunnel release (CTR), involves division of the transverse carpal ligament. Surgery can be performed under axillary or intravenous block, or general anaesthesia. There are no prior randomised controlled trials (RCT) comparing local infiltration anaesthesia to local infiltration anaesthesia augmented with a distal median nerve block in CTR.
The aim of this trial is to investigate whether adding a distal median nerve block to local anaesthesia reduces the patient's perceived pain level for up to 72 hours after CTR, compared to using only local anaesthesia, i.e., an anaesthesia mixture injected solely in and around the planned incision and nerve release. The null hypothesis is that the use of distal median nerve block with local anaesthesia does not reduce pain after CTR compared to pure local anaesthesia.
PERSONNEL (carPal tunnEl ReleaSe lOcal iNfiltratioN mEdian bLockade) is a double-blinded, i.e., patient and investigators, RCT in patients with CTS. Patients will be randomly divided into two parallel trial groups, 1:1 in size to each other. Fifty-nine patients will be needed for each group to have adequate power. The primary outcome is the pain level perceived by the patient after the procedure during the first 72 hours using the Visual Analogue Scale (VAS). Secondary outcomes include patient-rated outcome measures, safety, the entire consumption of pain killers after the surgery during the first 72 hours postoperatively, pain of performing the anaesthesia, and pain during and after the operation.
No trial comparing local anaesthesia to local anaesthesia augmented with distal median nerve block has been published before. There is also no trial noting individual tolerance to pain. The quality of the median nerve block at the wrist has been achieved by using sensory or sensory-motor nerve stimulation and has been proven effective. This increases trust in the effectiveness of the treatment method, but it still needs to be adequately proven which is the goal of this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Two concurrent study groups
| Arm | Type | Receives |
|---|---|---|
| Local infiltration anaesthesia in carpal tunnel release | Active comparator | Procedure: Local infiltration anaesthesia in carpal tunnel releaseThe investigators allocate 59 patients in this arm. It serves as the control group, who receives local infiltration anaesthesia. |
| Distal median nerve block with local infiltration anaesthesia in carpal tunnel release | Experimental | Procedure: Distal median nerve block with local infiltration anaesthesia in carpal tunnel releaseThe investigators allocate 59 patients in this arm. It serves as the experimental group, who receives local infiltration anaesthesia and distal median nerve block. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥18 years of age
- CTS verified by nerve conduction studies
- Symptoms suitable for CTS
Key exclusion criteria (5 listed)
- Recurrent CTS
- Peripheral neuropathies
- Known allergy to the trial drugs
- Profound cognitive impairment
- Pregnancy
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 |
|---|---|---|
| Local infiltration anaesthesia in carpal tunnel releaseThe anaesthetic cocktail consists of 1 ml of (7.5%) sodium bicarbonate (Natriumbicarbonate Braun 75mg/ml), 4,5 ml of lidocaine with adrenaline 1% (Lidocain cum adrenalin 10 mg/ml), 4,5 ml of bupivacaine with adrenaline 0.5% (Marcain cum adrenalin 5mg/ml +5 µg/ml). The anaesthetic cocktail must be prepared in the above-mentioned order to avoid possible precipitation. A 24-gauge hypodermic needle and 10 ml syringe are used to inject the solution. The care provider pinches from the area of median nerve blockade prior to performing local anaesthesia. All the anaesthetic solution is injected locally. Additional anaesthetic solution can be injected locally if necessary. | Procedure or surgery | Local infiltration anaesthesia in carpal tunnel release |
| Distal median nerve block with local infiltration anaesthesia in carpal tunnel releaseThe anaesthetic cocktail consists of 1 ml of (7.5%) sodium bicarbonate (Natriumbicarbonate Braun 75mg/ml), 4,5 ml of lidocaine with adrenaline 1% (Lidocain cum adrenalin 10 mg/ml), 4,5 ml of bupivacaine with adrenaline 0.5% (Marcain cum adrenalin 5mg/ml +5 µg/ml). The anaesthetic cocktail must be prepared in the above-mentioned order to avoid possible precipitation. A 24-gauge hypodermic needle and 10 ml syringe are used to inject the solution. Half of the anaesthetic solution is injected into the median nerve area 5-7 cm proximally from the distal wrist crease. The other half is injected locally. Additional anaesthetic solution can be injected locally if necessary. | Procedure or surgery | Distal median nerve block with local infiltration anaesthesia in carpal tunnel release |
Primary outcome
The pain level perceived by the patient after the procedure using Visual Analogue Scale (VAS)
Time frame: Postoperatively during the first 72 hours after the operation
The investigators measure the pain level perceived by the patient after the procedure every fourth hour while awake until third night postoperatively using VAS. The first assessment is performed four hours after the surgery. The mean VAS is calculated from all time points over the 72-hour period. The Visual analogue Scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable.
12 secondary outcomes
Pressure pain (VAS)
Time frame: Immediately after the infiltration of anaesthetic solution
Burning pain (VAS)
Time frame: Immediately after the infiltration of anaesthetic solution
Needle sting pain (VAS)
Time frame: Immediately after the infiltration of anaesthetic solution
Total pain during the injection of the anaesthetic solution (VAS)
Time frame: Immediately after the infiltration of anaesthetic solution
Worst pain during the operation (VAS)
Time frame: Immediately after the operation
Duration of anaesthesia
Time frame: Postoperatively during the first 72 hours after the operation
Self-reported symptom severity and functional status
Time frame: Before and 3 months postoperatively
Patient satisfaction
Time frame: 3 months postoperatively
Adverse events (AE)
Time frame: 3 months postoperatively
Expected pain (VAS)
Time frame: Before the infiltration of the anaesthetic solution
Amount of perceived needle stings
Time frame: Immediately after the infiltration of anaesthetic solution
Consumption of pain killers
Time frame: Postoperatively during the first 72 hours after the operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Background: PubMed 21477381Shi Q, MacDermid JC. Is surgical intervention more effective than non-surgical treatment for carpal tunnel syndrome? A systematic review. J Orthop Surg Res. 2011 Apr 11;6:17. doi: 10.1186/1749-799X-6-17.
- Background: PubMed 17613571Piazzini DB, Aprile I, Ferrara PE, Bertolini C, Tonali P, Maggi L, Rabini A, Piantelli S, Padua L. A systematic review of conservative treatment of carpal tunnel syndrome. Clin Rehabil. 2007 Apr;21(4):299-314. doi: 10.1177/0269215507077294.
- Background: PubMed 15891983Keir PJ, Rempel DM. Pathomechanics of peripheral nerve loading. Evidence in carpal tunnel syndrome. J Hand Ther. 2005 Apr-Jun;18(2):259-69. doi: 10.1197/j.jht.2005.02.001.
- Background: PubMed 26323649Kozak A, Schedlbauer G, Wirth T, Euler U, Westermann C, Nienhaus A. Association between work-related biomechanical risk factors and the occurrence of carpal tunnel syndrome: an overview of systematic reviews and a meta-analysis of current research. BMC Musculoskelet Disord. 2015 Sep 1;16:231. doi: 10.1186/s12891-015-0685-0.
- Background: PubMed 20976778Padua L, Di Pasquale A, Pazzaglia C, Liotta GA, Librante A, Mondelli M. Systematic review of pregnancy-related carpal tunnel syndrome. Muscle Nerve. 2010 Nov;42(5):697-702. doi: 10.1002/mus.21910.
- Background: PubMed 11805259Mondelli M, Giannini F, Giacchi M. Carpal tunnel syndrome incidence in a general population. Neurology. 2002 Jan 22;58(2):289-94. doi: 10.1212/wnl.58.2.289.
- Background: PubMed 26395787Shiri R, Pourmemari MH, Falah-Hassani K, Viikari-Juntura E. The effect of excess body mass on the risk of carpal tunnel syndrome: a meta-analysis of 58 studies. Obes Rev. 2015 Dec;16(12):1094-104. doi: 10.1111/obr.12324. Epub 2015 Sep 23.
- Background: PubMed 25204641Shiri R. Hypothyroidism and carpal tunnel syndrome: a meta-analysis. Muscle Nerve. 2014 Dec;50(6):879-83. doi: 10.1002/mus.24453. Epub 2014 Oct 30.
- Background: PubMed 26173490Pourmemari MH, Shiri R. Diabetes as a risk factor for carpal tunnel syndrome: a systematic review and meta-analysis. Diabet Med. 2016 Jan;33(1):10-6. doi: 10.1111/dme.12855. Epub 2015 Aug 18.
- Background: PubMed 26229841Chammas M, Boretto J, Burmann LM, Ramos RM, Dos Santos Neto FC, Silva JB. Carpal tunnel syndrome - Part I (anatomy, physiology, etiology and diagnosis). Rev Bras Ortop. 2014 Aug 20;49(5):429-36. doi: 10.1016/j.rboe.2014.08.001. eCollection 2014 Sep-Oct.
- Background: PubMed 32313774Genova A, Dix O, Saefan A, Thakur M, Hassan A. Carpal Tunnel Syndrome: A Review of Literature. Cureus. 2020 Mar 19;12(3):e7333. doi: 10.7759/cureus.7333.
- Background: PubMed 25177448Kim PT, Lee HJ, Kim TG, Jeon IH. Current approaches for carpal tunnel syndrome. Clin Orthop Surg. 2014 Sep;6(3):253-7. doi: 10.4055/cios.2014.6.3.253. Epub 2014 Aug 5.
- Individual participant dataSharing planned: Yes. This trial will share data with researchers who submit a methodologically sound proposal after its completion, as well as with reviewers of the journal where the trial results will be published, if necessary.
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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.
Yrjänä Nietosvaara, Prof. study director
Kuopio University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local infiltration anaesthesia in carpal tunnel release and Distal median nerve block with local infiltration anaesthesia in carpal tunnel release in people with Carpal Tunnel Syndrome, run by Kuopio University Hospital at 1 site in Finland.
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 5 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: looking for participants now, as of the sponsor's last update on 19 Sep 2025. 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 Finland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noora Heikkinen, MBBS (+358504421930, noorheik@student.uef.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pain level perceived by the patient after the procedure using Visual Analogue Scale (VAS) (time frame: Postoperatively during the first 72 hours after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05372393, which also lists 25 linked publications.
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 19 Sep 2025.