An interventional study of Continuous interscalene block and PCA morphine in Brachial Plexus Injury, sponsored by Centre Hospitalier Universitaire Vaudois. Withdrawn at 1 site in Switzerland. Open to participants aged 16 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-20.
Sponsored by Centre Hospitalier Universitaire Vaudois · Not applicable, Interventional, and Diagnostic
Brachial plexus injury after shoulder surgery with continuous interscalene block is 2.4% at 1 month and 0% at 6 months, but may be higher with a systematic postoperative neurological examination. Indeed, femoral neuropathy after anterior cruciate ligament reconstruction is 24% at 6 weeks in a cohort of 20 consecutive patients systematically screened with an electromyogram. Brachial plexus injury may be the consequence of the surgery (direct lesion by traction) or the continuous interscalene block. The goal of this study is to define the etiology of this postoperative neuropathy.
Rotator cuff surgery is associated with moderate to severe postoperative pain. Among different analgesic strategies, continuous interscalene block is reported to be an efficient method, reducing opioid consumption and allowing rapid rehabilitation; however, patients may develop a transient neuropathy after surgery, which could have a significant impact on active patients. This study is designed to compare the incidence of brachial plexus injury in two groups of patients: one with a continuous interscalene block, and one with a patient control analgesia of morphine (self-iv administration of morphine). All patients will have a clinical neurological exam with a preoperative electromyogram in order to rule out a pre-existing neuropathy. Another clinical neurological exam with electromyogram will be performed between 4 and 6 postoperative weeks and, if pathological repeated at 6 months, 9 months and 12 months. The surgery will be done under general anesthesia for all patients.
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Exclusion Criteria:
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
Patients with iv self-administration of morphine, associated with paracetamol and ibuprofen. Each group will contain 60 patients.
Procedure: PCA morphine
The continuous interscalene block will be performed with ultrasound 30 minutes before the intervention.
Postoperative with iv self-administration of morphine
Incidence of brachial plexus injury
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.
Time frame: 6 weeks
This study is withdrawn, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire Vaudois