Surgical Treatment of Carpal Tunnel Syndrome: Local Anesthesia With Epinephrine x Intravenous Regional Anesthesia.

NCT02986347 | Completed DMC

• 1 other identifier: HAMAO01
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The anesthetic technique of choice for surgical treatment of CTS varies among surgeons. In the last decade some studies have described the performance of this surgery using local anesthesia with adrenaline without the necessity of sedation or the use of pneumatic garrote, having good effectiveness and substantial reduction of costs. However there is need for studies with an appropriate design and methodology to evaluate the actual effectiveness of this kind of anesthesia for the surgical treatment of CTS. Objective: To evaluate the effectiveness and cost of open surgery for CTS in a randomized trial comparing two anesthesia methods: intravenous regional anesthesia (Bier) and local anesthesia with adrenaline without limb garroting (Lalondi). Methods: This study was developed in the Group of Hand Surgery and Upper Limb; Department of Orthopedics and Traumatology, Federal University of São Paulo, UNIFESP / EPM with co-participation of the Hand Surgery and Microsurgery Department of Hospital Alvorada. This study will be a Randomized Clinical Trial. The previous calculation of the sample resulted in 78 patients. The following primary outcomes will be assessed: Pain through visual analogue scale (VAS). Costs: Costs related to anesthetic and surgical procedures will be recorded. The secondary outcomes will be: Use of Analgesics, Anxiety and Depression through the HADS (Hospital Anxiety and Depression Scale) scale. Quality of life through the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ). Remission of paresthesia after surgical intervention, complications and failures.

Conditions

Carpal Tunnel Syndrome; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Change in pain through Pain visual analogue scale

  Pain measurement through visual analog scale

  Before the treatment and after the treatment (intraoperative and after the treatment:immediate postoperative, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours after the end of surgery.

Secondary Outcomes (5)

• The total costs of carpal tunnel syndrome surgical treatment will be tracked over the duration of the study to determine the cost-effectiveness of providing a Local Anesthesia With Epinephrine versus a Intravenous Regional Anesthesia.

  3 months

• Change of the Boston Carpal Tunnel Questionnaire (BCTQ)

  preoperatively and 12 weeks post-operation

• Hospital Anxiety and Depression Scale (HADS)

  preoperatively and 12 weeks post-operation

• Remission or not of paresthesia until the third month

  preoperatively and 12 weeks post-operation

• Record and evaluate all complications associated with the surgical procedure

  12 weeks post-operation

Study Arms (2)

Intravenous regional anesthesia (Bier)

ACTIVE COMPARATOR

The anesthetic technique described by Bier will be done by the anesthesiologist. The following steps were followed: 1)Placement double tourniquet on the proximal portion of the arm 2)Asepsis and antisepsis of the operative limb 3)Puncture and venous catheterization most distal in the limb 4)Elevation of limb for 1 to 2 minutes, next the limb will be spirally wrapped with Esmarch from the distal to proximal 5)The proximal cuff will be inflated 6)Withdrawal of Esmarch and injection of 40ml of lidocaine without epinephrine at 0.5% 7)Removal the canula until the distal cuff is inflated and the proximal cuff is emptied 8)Removal of the club must be done after the surgery, at least 40 minutes after the injection of the anesthetic.

Procedure: Intravenous regional anesthesia (Bier)

Local anesthesia with adrenaline

ACTIVE COMPARATOR

Patients will be anesthetized by surgeons, who are familiar with the technique described by Lalonde. Around thirty minutes before surgery, will be infused with 20 ml of an anesthetic solution. The infiltrated solution is composed of 1% lidocaine with epinephrine in 1: 100,000. Initially 10 mL of the solution will be applied slowly in the flexion fold region of the wrist just below the skin and subfascial plane. The needle is moved slowly. The needle is then redirected to the radial side of the proximal palmar region for infiltration of another 2-3 mL of the subcutaneous solution. The remaining 7-8mL in the subdermal plane and anterior to the transverse carpal ligament.

Procedure: Local anesthesia with adrenaline

Interventions

Intravenous regional anesthesia (Bier) PROCEDURE

Intravenous regional anesthesia (Bier Technique)

Intravenous regional anesthesia (Bier)

Local anesthesia with adrenaline PROCEDURE

local anesthesia with adrenaline without limber garroting (Lalonde Technique)

Local anesthesia with adrenaline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years of age, with idiopathic Carpal Tunnel Syndrome with indication for surgery due to failure of conservative treatment for at least three months or that presented at the initial diagnosis with motor impairment detected by clinical examination (hypotrophy) and/or by electromyography (ENMG) examination.
• The diagnosis of CTS will be made through the clinical evaluation in which CTS patients will be considered, those who present at least four of the clinical criteria proposed and proven by the electromyography examination.
• Clinical Criteria for CTS - (At least 4 criteria will be required for clinical confirmation of the diagnosis)
• Paresthesia in the territory of the median nerve
• Night paresthesia of the hand
• Decreased strength with hypotrophy of the musculature tenar
• Positive tinnitus sign on the wrist
• Positive Phalen test
• Loss of 2-point discrimination in the region innervated by the median nerve
• Patients who agree to participate, after having been adequately informed about the nature of the study, and have reading and signed the informed consent form.

You may not qualify if:

• Patients with prior history of cervical spine diseases (radiculopathies, arthrosis),
• Pregnant women and puerperal women,
• Patients with sequelae of previous wrist and hand surgeries,
• Other upper limb compressive syndromes and scapular girdles will be excluded

Sponsors & Collaborators

• Hospital Alvorada: lead
• Federal University of São Paulo: collaborator

Study Sites (1)

Aldo Okamura

São Paulo, 03325000, Brazil

Location

Related Publications (8)

• Mckee DE, Lalonde DH, Thoma A, Dickson L. Achieving the optimal epinephrine effect in wide awake hand surgery using local anesthesia without a tourniquet. Hand (N Y). 2015 Dec;10(4):613-5. doi: 10.1007/s11552-015-9759-6. Epub 2015 Apr 14.

  PMID: 26568713 BACKGROUND

• Davison PG, Cobb T, Lalonde DH. The patient's perspective on carpal tunnel surgery related to the type of anesthesia: a prospective cohort study. Hand (N Y). 2013 Mar;8(1):47-53. doi: 10.1007/s11552-012-9474-5.

  PMID: 24426892 BACKGROUND

• Lalonde D, Bell M, Benoit P, Sparkes G, Denkler K, Chang P. A multicenter prospective study of 3,110 consecutive cases of elective epinephrine use in the fingers and hand: the Dalhousie Project clinical phase. J Hand Surg Am. 2005 Sep;30(5):1061-7. doi: 10.1016/j.jhsa.2005.05.006.

  PMID: 16182068 BACKGROUND

• Levine DW, Simmons BP, Koris MJ, Daltroy LH, Hohl GG, Fossel AH, Katz JN. A self-administered questionnaire for the assessment of severity of symptoms and functional status in carpal tunnel syndrome. J Bone Joint Surg Am. 1993 Nov;75(11):1585-92. doi: 10.2106/00004623-199311000-00002.

  PMID: 8245050 BACKGROUND

• Leblanc MR, Lalonde J, Lalonde DH. A detailed cost and efficiency analysis of performing carpal tunnel surgery in the main operating room versus the ambulatory setting in Canada. Hand (N Y). 2007 Dec;2(4):173-8. doi: 10.1007/s11552-007-9043-5. Epub 2007 May 30.

  PMID: 18780048 BACKGROUND

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 BACKGROUND

• Robles DS, Esteves S, Liça M, Lopes D, Lima S, Sousa C. Tratamento da síndrome do túnel cárpico:anestesia geral versus local?. Rev Port Ortop e Traum 23(3):217-224, 2015.

  BACKGROUND

• Okamura A, Moraes VY, Fernandes M, Raduan-Neto J, Belloti JC. WALANT versus intravenous regional anesthesia for carpal tunnel syndrome: a randomized clinical trial. Sao Paulo Med J. 2021 Oct 11;139(6):576-578. doi: 10.1590/1516-3180.2020.0583.R2.0904221. eCollection 2021.

  PMID: 34644765 DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Anesthesia, Local; Epinephrine

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Aldo Okamura, MD

  Hospital Alvorada de Moema

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: open label
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 11, 2016
• First Posted: December 8, 2016
• Study Start: May 27, 2017
• Primary Completion: January 1, 2020
• Study Completion: March 1, 2020
• Last Updated: April 15, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)