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

NCT ID: NCT01334632

Last Updated: 2014-03-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2013-11-30

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.

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.

Conditions

Brachial Plexus Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Continuous interscalene block

Intervention Type: PROCEDURE

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

PCA morphine

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

Group Type: PLACEBO_COMPARATOR

PCA morphine

Intervention Type: PROCEDURE

Postoperative with iv self-administration of morphine

Interventions

Continuous interscalene block

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

Intervention Type: PROCEDURE

PCA morphine

Postoperative with iv self-administration of morphine

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: lead

Responsible Party

Centre Hospitalier Universitaire Vaudois and University of Lausanne

Principal Investigators

Eric Albrecht, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

Other Identifiers

CHUV-74-10

Identifier Type: -

Identifier Source: org_study_id