CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 78 enrolled
Drug / intervention
Intravenous regional anesthesia (Bier) +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02986347
NCT02986347N/ACompleted

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

Hospital Alvorada·interventional·Posted Dec 8, 2016·Updated Apr 15, 2020

In Brief

A clinical study evaluating Intravenous regional anesthesia (Bier) and Local anesthesia with adrenaline for Carpal Tunnel Syndrome and Anesthesia. Completed, enrolled 78 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedDec 8, 2016
Enrollment StartMay 27, 2017
Primary CompletionJan 1, 2020
Study CompletionMar 1, 2020
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 9.6 years ago

Interventions

Intravenous regional anesthesia (Bier)procedure

Intravenous regional anesthesia (Bier Technique)

Local anesthesia with adrenalineprocedure

local anesthesia with adrenaline without limber garroting (Lalonde Technique)