Trial record 1 of 33 for:    Brachial Plexus Injuries
Previous Study | Return to List | Next Study

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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention
Brachial Plexus Injury
Procedure: Continuous interscalene block
Procedure: PCA morphine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Comparison of Incidence of Brachial Plexus Injury After Rotator Cuff Repair With Continuous Interscalene Block Versus Patient Controlled Analgesia Morphine

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Vaudois:

Primary Outcome Measures:
  • 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.


Enrollment: 0
Study Start Date: April 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01334632

Locations
Switzerland
Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Investigators
Principal Investigator: Eric Albrecht, MD Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne
  More Information

No publications provided

Responsible Party: Department of Anaesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne
ClinicalTrials.gov Identifier: NCT01334632     History of Changes
Other Study ID Numbers: CHUV-74-10
Study First Received: April 11, 2011
Last Updated: March 19, 2014
Health Authority: Switzerland: Laws and standards

Keywords provided by Centre Hospitalier Universitaire Vaudois:
Electrophysiological study
Nerve block
Analgesia, patient-controlled
Shoulder surgery

Additional relevant MeSH terms:
Wounds and Injuries
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014