Last reviewed · How we verify

NCT02986347

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

Completed NA Last updated 15 April 2020
What this trial tests

NA trial testing Intravenous regional anesthesia (Bier) in Carpal Tunnel Syndrome in 78 participants. Completed in 1 March 2020.

Timeline
27 May 2017
Primary endpoint
1 January 2020
1 March 2020

Quick facts

Lead sponsorHospital Alvorada
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposehealth services research
Enrollment78
Start date27 May 2017
Primary completion1 January 2020
Estimated completion1 March 2020
Sites1 location across Brazil

Drugs / interventions tested

Conditions studied

Sponsor

Hospital Alvorada

Who can join

18 and older, any sex, with Carpal Tunnel Syndrome or Anesthesia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. WALANT versus intravenous regional anesthesia for carpal tunnel syndrome: a randomized clinical trial.
    Okamura A, Moraes VY, Fernandes M, Raduan-Neto J, et al · · 2021 · cited 12× · PMID 34644765 · DOI 10.1590/1516-3180.2020.0583.r2.0904221

Verify or expand the search:

Other recruiting trials for Carpal Tunnel Syndrome

Currently open trials in the same condition.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02986347.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing