NCT01334632

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Centre Hospitalier Universitaire Vaudois · Academic / Other
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
PROCEDURE	Continuous interscalene block	The continuous interscalene block will be performed with ultrasound 30 minutes before the intervention.
PROCEDURE	PCA morphine	Postoperative with iv self-administration of morphine

Timeline

• Start date: 2011-04-01
• Primary completion: 2013-03-01
• Completion: 2013-11-01
• First posted: 2011-04-13
• Last updated: 2014-03-20

Locations

1 site across 1 country: Switzerland