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

Vaud University Hospital Center

Status: Withdrawn

Conditions: Brachial Plexus Injury

Treatments: Procedure: PCA morphine; Procedure: Continuous interscalene block

Study type: Interventional

Funder types: Other

Identifiers

NCT01334632

CHUV-74-10

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 16 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups, including a placebo group

Continuous interscalene block

Active Comparator group

Description:

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.

Treatment:

Procedure: Continuous interscalene block

PCA morphine

Placebo Comparator group

Description:

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

Treatment:

Procedure: PCA morphine