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

Primary Purpose

Brachial Plexus Injury

Status
Withdrawn
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Continuous interscalene block
PCA morphine
Sponsored by
Centre Hospitalier Universitaire Vaudois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brachial Plexus Injury focused on measuring Electrophysiological study, Nerve block, Analgesia, patient-controlled, Shoulder surgery

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Continuous interscalene block

PCA morphine

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 11, 2011
Last Updated
March 19, 2014
Sponsor
Centre Hospitalier Universitaire Vaudois
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1. Study Identification

Unique Protocol Identification Number
NCT01334632
Brief Title
Incidence of Brachial Plexus Injury After Rotator Cuff Repair With Continuous Interscalene Block
Official Title
Comparison of Incidence of Brachial Plexus Injury After Rotator Cuff Repair With Continuous Interscalene Block Versus Patient Controlled Analgesia Morphine
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Withdrawn
Why Stopped
Change of practice in the department (Nerve stimulation technique abandoned)
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
November 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Centre Hospitalier Universitaire Vaudois

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brachial Plexus Injury
Keywords
Electrophysiological study, Nerve block, Analgesia, patient-controlled, Shoulder surgery

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous interscalene block
Arm Type
Active Comparator
Arm 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.
Arm Title
PCA morphine
Arm Type
Placebo Comparator
Arm Description
Patients with iv self-administration of morphine, associated with paracetamol and ibuprofen. Each group will contain 60 patients.
Intervention Type
Procedure
Intervention Name(s)
Continuous interscalene block
Intervention Description
The continuous interscalene block will be performed with ultrasound 30 minutes before the intervention.
Intervention Type
Procedure
Intervention Name(s)
PCA morphine
Intervention Description
Postoperative with iv self-administration of morphine
Primary Outcome Measure Information:
Title
Incidence of brachial plexus injury
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Albrecht, MD
Organizational Affiliation
Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

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

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