An interventional study of Intravenous regional anesthesia (Bier) and Local anesthesia with adrenaline in Carpal Tunnel Syndrome and Anesthesia, sponsored by Hospital Alvorada. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-15.
Sponsored by Hospital Alvorada · Not applicable, Interventional, and Health services research
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.
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.
589 studies on the registry are indexed under Carpal Tunnel Syndrome; 139 are open to participants now.
This study's enrollment of 78 is above the median of 60 across 445 interventional studies indexed under Carpal Tunnel Syndrome.
Browse Carpal Tunnel Syndrome studies →Hospital Alvorada is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Clinical Criteria for CTS - (At least 4 criteria will be required for clinical confirmation of the diagnosis)
Loss of 2-point discrimination in the region innervated by the median nerve
Exclusion Criteria:
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)
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
Intravenous regional anesthesia (Bier Technique)
local anesthesia with adrenaline without limber garroting (Lalonde Technique)
Change in pain through Pain visual analogue scale
Pain measurement through visual analog scale
Time frame: 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.
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
Time frame: 3 months
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.
Time frame: preoperatively and 12 weeks post-operation
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.
Time frame: preoperatively and 12 weeks post-operation
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.
Time frame: preoperatively and 12 weeks post-operation
Record and evaluate all complications associated with the surgical procedure
Complications rate of surgical and anesthesic procedures in patients with CTS
Time frame: 12 weeks post-operation
Plan to share: No
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