Clinical trial NCT05372393: 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 Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: carpal tunnel syndrome
carpal tunnel release
local anaesthesia
surgery
wide-awake local anaesthesia with no tourniquet
nerve block
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: University of Eastern Finland
First posted: 2022-05-12
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two concurrent study groups
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: The pain level perceived by the patient after the procedure using Visual Analogue Scale (VAS)
timeFrame: Postoperatively during the first 72 hours after the operation
Secondary outcomes:
measure: Pressure pain (VAS)
timeFrame: Immediately after the infiltration of anaesthetic solution
measure: Burning pain (VAS)
timeFrame: Immediately after the infiltration of anaesthetic solution
measure: Needle sting pain (VAS)
timeFrame: Immediately after the infiltration of anaesthetic solution
measure: Total pain during the injection of the anaesthetic solution (VAS)
timeFrame: Immediately after the infiltration of anaesthetic solution
measure: Worst pain during the operation (VAS)
timeFrame: Immediately after the operation
measure: Duration of anaesthesia
timeFrame: Postoperatively during the first 72 hours after the operation
measure: Self-reported symptom severity and functional status
timeFrame: Before and 3 months postoperatively
measure: Patient satisfaction
timeFrame: 3 months postoperatively
measure: Adverse events (AE)
timeFrame: 3 months postoperatively
measure: Expected pain (VAS)
timeFrame: Before the infiltration of the anaesthetic solution
measure: Amount of perceived needle stings
timeFrame: Immediately after the infiltration of anaesthetic solution
measure: Consumption of pain killers
timeFrame: Postoperatively during the first 72 hours after the operation
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University hospital, Department of Orthopaedics, Traumatology and Hand Surgery
state: Pohjois-Savo
Study officials:
affiliation: Kuopio University Hospital
name: Yrjänä Nietosvaara, Prof.
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
citation: 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.
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.
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.
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.
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.
citation: Wipperman J, Goerl K. Carpal Tunnel Syndrome: Diagnosis and Management. Am Fam Physician. 2016 Dec 15;94(12):993-999.
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.
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.
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.
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.
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.
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.
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.