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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02986347
• Other study ID #: HAMAO01
• Status: Completed
• Phase: N/A
• Start date: May 27, 2017
• Est. completion date: March 1, 2020

Study information

• Verified date: April 2020
• Source: Hospital Alvorada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Surgical treatment of CTS is most often performed under hospital conditions, with the use of anesthesia. The anesthetic technique of choice 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 for the procedure with this anesthetic method. However, when we evaluated the level and strength of the evidence from these studies, we notice that there is a 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 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 the Medical Residency Service in Hand Surgery of Hospital Alvorada. This study will be a Randomized Clinical Trial. The previous calculation of the sample resulted in the need for total inclusion of 35 patients in each group, total of 70 patients, considering a loss of 10% during follow-up we will include 78 patients. The following primary outcomes will be assessed: Pain through visual analogue scale (VAS), that, will be measured in the pre-operative, transoperatory, immediate postoperative, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours after surgery. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: March 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

1. Paresthesia in the territory of the median nerve

2. Night paresthesia of the hand

3. Decreased strength with hypotrophy of the musculature tenar

4. Positive tinnitus sign on the wrist

5. Positive Phalen test

6. 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anesthesia
• Carpal Tunnel Syndrome
• Syndrome

Intervention

Procedure:
• Intravenous regional anesthesia (Bier)
Intravenous regional anesthesia (Bier Technique)
• Local anesthesia with adrenaline
local anesthesia with adrenaline without limber garroting (Lalonde Technique)

Locations

Country	Name	City	State
Brazil	Aldo Okamura	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Alvorada	Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	The following costs related to anesthetic and surgical procedures will be computed: consumer material used in the anesthetic and surgical procedure; medical and paramedical staff; time of use of the surgical rooms for postoperative recovery; length of hospital stay; medicines used up to one postoperative week; necessary costs for the treatment of possible complications	3 months
Secondary	Change of the Boston Carpal Tunnel Questionnaire (BCTQ)	Patients in the study group will respond to Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) translated and validated for Portuguese preoperative (after initial clinical evaluation) and postoperative (3th month PO). It is a disease specific questionnaire, self-administered, and evaluates the severity of the symptoms and functional status of patients with CTS. The BCTQ assesses the symptoms and the severity, frequency, time and type. The functional degree of scale evaluates how the syndrome affects daily life. Issues relating to the severity scale are composed of 11 questions. Each question has five answers, placed in order of increasing severity of symptoms. The issues relating to the functional status are composed of 8 questions, each of which corresponds to a functional activity. Each activity has a 5-degree-answer of difficulty progressively worsening.	preoperatively and 12 weeks post-operation
Secondary	Hospital Anxiety and Depression Scale (HADS)	Hospital Anxiety and Depression Scale (HADS) questionnaire. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.	preoperatively and 12 weeks post-operation
Secondary	Remission or not of paresthesia until the third month	The absence of paresthesia reported by the patient after surgery will be considered as "cure". The not regression paresthesia referred by patients in this period will be considered as non-healing.	preoperatively and 12 weeks post-operation
Secondary	Record and evaluate all complications associated with the surgical procedure	Complications rate of surgical and anesthesic procedures in patients with CTS	12 weeks post-operation