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.

Study Overview

• Status: Withdrawn
• Conditions: Brachial Plexus Injury
• Intervention / Treatment: Procedure: Continuous interscalene block; Procedure: PCA 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois
• Investigators: Principal Investigator: Eric Albrecht, MD, Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Anticipated): March 1, 2013
• Study Completion (Anticipated): November 1, 2013

Study Registration Dates

• First Submitted: April 11, 2011
• First Submitted That Met QC Criteria: April 12, 2011
• First Posted (Estimate): April 13, 2011

Study Record Updates

• Last Update Posted (Estimate): March 20, 2014
• Last Update Submitted That Met QC Criteria: March 19, 2014
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Shoulder surgery; Nerve block; Electrophysiological study; Analgesia, patient-controlled
• Additional Relevant MeSH Terms: Wounds and Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: CHUV-74-10