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

Official title

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

Overview

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.

Interventions

• 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 n
• Procedure 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 t

Primary outcome measures

• 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]

Secondary outcome measures (12)

• 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]

Eligibility criteria

Inclusion criteria

• ≥18 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Finland · 1 center

• Kuopio University hospital, Department of Orthopaedics, Traumatology and Hand Surgery — Kuopio

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. PMID 21477381
• 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. PMID 17613571
• 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. PMID 15891983
• 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. PMID 26323649
• 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. PMID 20976778
• 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. PMID 11805259
• 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. PMID 26395787
• 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. PMID 25204641

Identifiers

NCT: NCT05372393 · KUH5203140

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗