Brachial Plexus InjuryNCT01334632
Incidence of Brachial Plexus Injury After Rotator Cuff Repair With Continuous Interscalene Block
A study testing Continuous interscalene block and PCA morphine in people with Brachial Plexus Injury, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Brachial Plexus Injury
- What is being tested?
- Continuous interscalene block and PCA morphine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2011to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients planned for rotator cuff repair
- ASA 1, 2 and 3
- age 16 years and more
Who cannot join
- peripheral neuropathy
- pre-existing brachial plexus injury
- diabetes mellitus
- alcoholism
- drug addiction
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne
Lausanne, Canton of Vaud, 1011
About this study
Official title: Comparison of Incidence of Brachial Plexus Injury After Rotator Cuff Repair With Continuous Interscalene Block Versus Patient Controlled Analgesia Morphine
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.
Read the 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
- Being tested
- Continuous interscalene block, PCA morphine
- Keywords
- Electrophysiological study, Nerve block, Analgesia, patient-controlled, Shoulder surgery
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous interscalene blockProcedure or surgery
The continuous interscalene block will be performed with ultrasound 30 minutes before the intervention.
PCA morphineProcedure or surgery
Postoperative with iv self-administration of morphine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: PCA morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionMar 2013 (estimated)
- Study completionNov 2013 (estimated)
Why it stopped: Change of practice in the department (Nerve stimulation technique abandoned)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brachial Plexus InjuryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Investigators
- Eric Albrecht, MD, Principal investigator, Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334632
- Sponsor's protocol ID
- CHUV-74-10
- Status last verified
- Apr 2011
- First submitted
- 11 Apr 2011
- Last updated
- 20 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Incidence of Brachial Plexus Injury After Rotator Cuff Repair With Continuous Interscalene Block Versus Patient Controlled Analgesia Morphine
- ClinicalTrials.gov ID
- NCT01334632
- Acronym / sponsor ID
- CHUV-74-10
- Conditions
- Brachial Plexus Injury
- Keywords
- Electrophysiological study, Nerve block, Analgesia, patient-controlled, Shoulder surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change of practice in the department (Nerve stimulation technique abandoned)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 13 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous interscalene block | Active comparator | Procedure: Continuous interscalene blockContinuous 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. |
| PCA morphine | Placebo comparator | Procedure: PCA morphinePatients with iv self-administration of morphine, associated with paracetamol and ibuprofen. Each group will contain 60 patients. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patients planned for rotator cuff repair
- ASA 1, 2 and 3
- age 16 years and more
Key exclusion criteria (5 listed)
- peripheral neuropathy
- pre-existing brachial plexus injury
- diabetes mellitus
- alcoholism
- drug addiction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous interscalene blockThe continuous interscalene block will be performed with ultrasound 30 minutes before the intervention. | Procedure or surgery | Continuous interscalene block |
| PCA morphinePostoperative with iv self-administration of morphine | Procedure or surgery | PCA morphine |
Primary outcome
Incidence of brachial plexus injury
Time frame: 6 weeks
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Albrecht, MD principal investigator
Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous interscalene block and PCA morphine in people with Brachial Plexus Injury, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of brachial plexus injury (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2014.