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

NCT01334632 | Withdrawn

• 1 other identifier: CHUV-74-10
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brachial Plexus Injury

Keywords

Electrophysiological study; Nerve block; Analgesia, patient-controlled; Shoulder surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Continuous interscalene block

ACTIVE COMPARATOR

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

PCA morphine

PLACEBO COMPARATOR

Patients with iv self-administration of morphine, associated with paracetamol and ibuprofen. Each group will contain 60 patients.

Procedure: PCA morphine

Interventions

Continuous interscalene block PROCEDURE

The continuous interscalene block will be performed with ultrasound 30 minutes before the intervention.

Continuous interscalene block

PCA morphine PROCEDURE

Postoperative with iv self-administration of morphine

PCA morphine

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• peripheral neuropathy
• pre-existing brachial plexus injury
• diabetes mellitus
• alcoholism
• drug addiction

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric Albrecht, MD

  Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 11, 2011
• First Posted: April 13, 2011
• Study Start: April 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: November 1, 2013
• Last Updated: March 20, 2014

Record last verified: 2011-04

Locations

CH (1)