Carpal Tunnel Release Under Local Anaesthesia With or Without Distal Median Nerve Block

Carpal Tunnel Syndrome Clinical Trial

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Official title:

Carpal Tunnel Release Under Local Anaesthesia With or Without Distal Median Nerve Block - a Protocol of a Double Blinded Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05372393
• Other study ID #: KUH5203140
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2022
• Est. completion date: September 2027

Study information

• Verified date: March 2024
• Source: Kuopio University Hospital
• Contact: Noora Heikkinen, MBBS
• Phone: +358504421930
• Email: noorheik[@]student.uef.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Carpal tunnel syndrome is the most commonly appearing entrapment neuropathy of the upper extremity. Treatment options include both non-operative and surgical methods. Surgical treatment, carpal tunnel release (CTR), involves division of the transverse carpal ligament. Surgery can be done under an axillary- or intravenous block, or local or general anaesthesia. There are no randomised controlled trials comparing local infiltration anaesthesia with or without a distal median nerve block in carpal tunnel release.

The aim of the study is to investigate whether a distal median nerve block, in addition to local anaesthesia in carpal tunnel release, reduces pain during and after the procedure. 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.

This trial is a randomised controlled trial involving patients with carpal tunnel syndrome. Patients will be randomized into two study groups: local anaesthesia and local with a distal median nerve block. Fifty-nine patients will be needed for each group to have adequate power. The primary outcome is the pain level after the procedure for 72 hours using visual analogue scale. The secondary outcomes include expected pain; pain during the injection of the anaesthetic solution caused by pressure, burning, needle sting, and total pain; worst pain during the surgery; duration of anaesthesia; number of experienced needle stings; Boston Carpal Tunnel Syndrome Questionnaire; pain killer consumption, patient satisfaction, and safety .

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. Distal median block in CTR is believed to reduce pain intra- and postoperatively. However, the superiority of distal median block with local anaesthesia compared to pure local anaesthesia alone has not been proven.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: September 2027
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 17 years of age

• CTS verified by nerve conduction studies

• Symptoms suitable for CTS

Exclusion Criteria:

• Recurrent CTS

• Peripheral neuropathies

• Known allergy to the trial drugs

• Profound cognitive impairment

• Pregnancy

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome

Intervention

Procedure:
• Local infiltration anaesthesia in carpal tunnel release
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 release
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.

Locations

Country	Name	City	State
Finland	Kuopio University hospital, Department of Orthopaedics, Traumatology and Hand Surgery	Kuopio	Pohjois-Savo

Sponsors (2)

Lead Sponsor	Collaborator
Kuopio University Hospital	University of Eastern Finland

Country where clinical trial is conducted

Finland, 

References & Publications (22)

Chammas 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. — View Citation

Cranford CS, Ho JY, Kalainov DM, Hartigan BJ. Carpal tunnel syndrome. J Am Acad Orthop Surg. 2007 Sep;15(9):537-48. doi: 10.5435/00124635-200709000-00004. — View Citation

Delaunay L, Chelly JE. Blocks at the wrist provide effective anesthesia for carpal tunnel release. Can J Anaesth. 2001 Jul-Aug;48(7):656-60. doi: 10.1007/BF03016199. — View Citation

Genova 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. — View Citation

Iqbal HJ, Doorgakant A, Rehmatullah NNT, Ramavath AL, Pidikiti P, Lipscombe S. Pain and outcomes of carpal tunnel release under local anaesthetic with or without a tourniquet: a randomized controlled trial. J Hand Surg Eur Vol. 2018 Oct;43(8):808-812. doi: 10.1177/1753193418778999. Epub 2018 Jun 5. — View Citation

Jarvinen TL, Sihvonen R, Bhandari M, Sprague S, Malmivaara A, Paavola M, Schunemann HJ, Guyatt GH. Blinded interpretation of study results can feasibly and effectively diminish interpretation bias. J Clin Epidemiol. 2014 Jul;67(7):769-72. doi: 10.1016/j.jclinepi.2013.11.011. Epub 2014 Feb 20. — View Citation

Keir 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. — View Citation

Kim 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. — View Citation

Kozak 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. — View Citation

Mondelli 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. — View Citation

Ozdag Y, Hu Y, Hayes DS, Manzar S, Akoon A, Klena JC, Grandizio LC. Sensitivity and Specificity of Examination Maneuvers for Carpal Tunnel Syndrome: A Meta-Analysis. Cureus. 2023 Jul 24;15(7):e42383. doi: 10.7759/cureus.42383. eCollection 2023 Jul. — View Citation

Padua 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. — View Citation

Padua 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. — View Citation

Piazzini 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. — View Citation

Pourmemari 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. — View Citation

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. — View Citation

Shiri 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. — View Citation

Shiri R. Arthritis as a risk factor for carpal tunnel syndrome: a meta-analysis. Scand J Rheumatol. 2016 Oct;45(5):339-46. doi: 10.3109/03009742.2015.1114141. Epub 2016 Mar 29. — View Citation

Shiri 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. — View Citation

Wang 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. — View Citation

Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x. — View Citation

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 Visual analogue Scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable.	Postoperatively during the first 72 hours after the operation
Secondary	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.	Immediately after the infiltration of anaesthetic solution
Secondary	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.	Immediately after the infiltration of anaesthetic solution
Secondary	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.	Immediately after the infiltration of anaesthetic solution
Secondary	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.	Immediately after the infiltration of anaesthetic solution
Secondary	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.	Immediately after the operation
Secondary	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.	Postoperatively during the first 72 hours after the operation
Secondary	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.	Before and 3 months postoperatively
Secondary	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.	3 months postoperatively
Secondary	Adverse events (AE)	Health care professional assessment	3 months postoperatively
Secondary	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.	Before the infiltration of the anaesthetic solution
Secondary	Amount of perceived needle stings	The investigators ask the patient to report how many needle stings they felt when the anaesthesia was performed.	Immediately after the infiltration of anaesthetic solution
Secondary	Consumption of pain killers	The investigators record the consumption of pain killers after surgery	Postoperatively during the first 72 hours after the operation