Incidence of Brachial Plexus Injury After Rotator Cuff Repair With Continuous Interscalene Block

This study has been withdrawn prior to enrollment.
(Change of practice in the department (Nerve stimulation technique abandoned))
Sponsor:
Information provided by:
Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT01334632
First received: April 11, 2011
Last updated: March 19, 2014
Last verified: April 2011

April 11, 2011
March 19, 2014
April 2011
March 2013   (final data collection date for primary outcome measure)
Incidence of brachial plexus injury [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
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.
Incidence of brachial plexus injury [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Clinical neurological exam (dimished of absent bicipital, tricipital reflex, or sensory loss an ENMG (axon loss ratio, Hofman reflex, coumpound 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.
Complete list of historical versions of study NCT01334632 on ClinicalTrials.gov Archive Site
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Incidence of Brachial Plexus Injury After Rotator Cuff Repair With Continuous Interscalene Block
Comparison of Incidence of Brachial Plexus Injury After Rotator Cuff Repair With Continuous Interscalene Block Versus Patient Controlled Analgesia Morphine

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Brachial Plexus Injury
  • Procedure: Continuous interscalene block
    The continuous interscalene block will be performed with ultrasound 30 minutes before the intervention.
  • Procedure: PCA morphine
    Postoperative with iv self-administration of morphine
  • 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.
    Intervention: Procedure: Continuous interscalene block
  • Placebo Comparator: PCA morphine
    Patients with iv self-administration of morphine, associated with paracetamol and ibuprofen. Each group will contain 60 patients.
    Intervention: Procedure: PCA morphine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
November 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients planned for rotator cuff repair
  • ASA 1, 2 and 3
  • age 16 years and more

Exclusion Criteria:

  • peripheral neuropathy
  • pre-existing brachial plexus injury
  • diabetes mellitus
  • alcoholism
  • drug addiction
Both
16 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01334632
CHUV-74-10
No
Department of Anaesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne
Centre Hospitalier Universitaire Vaudois
Not Provided
Principal Investigator: Eric Albrecht, MD Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne
Centre Hospitalier Universitaire Vaudois
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP