Incidence of Brachial Plexus Injury After Rotator Cuff Repair With Continuous Interscalene Block
|ClinicalTrials.gov Identifier: NCT01334632|
Recruitment Status : Withdrawn (Change of practice in the department (Nerve stimulation technique abandoned))
First Posted : April 13, 2011
Last Update Posted : March 20, 2014
|Condition or disease||Intervention/treatment||Phase|
|Brachial Plexus Injury||Procedure: Continuous interscalene block Procedure: PCA morphine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comparison of Incidence of Brachial Plexus Injury After Rotator Cuff Repair With Continuous Interscalene Block Versus Patient Controlled Analgesia Morphine|
|Study Start Date :||April 2011|
|Estimated Primary Completion Date :||March 2013|
|Estimated Study Completion Date :||November 2013|
Active Comparator: Continuous interscalene block
Continuous interscalene block with bolus ropivacaine 0.5% and then continuous infusion of ropivacaine 0.2% 4 - 6 ml/h, associated with paracetamol and ibuprofen. Each group will contain 60 patients.
Procedure: Continuous interscalene block
The continuous interscalene block will be performed with ultrasound 30 minutes before the intervention.
Placebo Comparator: PCA morphine
Patients with iv self-administration of morphine, associated with paracetamol and ibuprofen. Each group will contain 60 patients.
Procedure: PCA morphine
Postoperative with iv self-administration of morphine
- Incidence of brachial plexus injury [ Time Frame: 6 weeks ]Clinical neurological exam (diminished or absent bicipital, tricipital reflex, or sensory loss on electromyoneurogram (axon loss ratio, Hoffmann reflex, compound muscle action potentials, any fibrillation potentials of the muscle at rest) at 6 weeks. A control will be done at 3 months, 6 months and 9 months if a neuropathy is diagnosed.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01334632
|Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne|
|Lausanne, Vaud, Switzerland, 1011|
|Principal Investigator:||Eric Albrecht, MD||Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne|