- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02821897
Value of Target-controlled Intravenous Anaesthesia (TCIVA) in Spinal Cord Stimulation (AIVOC)
April 4, 2019 updated by: Poitiers University Hospital
Value of Target-controlled Intravenous Anaesthesia (TCIVA) to Optimize Coverage of the Low Back Pain Territory in Patients With Chronic Refractory Postoperative Multifocal Low Back and Legpain
Study design 60 patients Monocenter prospective study Randomized in 2 groups 36 months Objectives Demonstrate the superiority of target controlled intravenous anesthesia versus total anesthesia with the low back paresthesia mapping in at least 95% of patients implanted with a multicolumn lead.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Worldwide
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Poitiers, Worldwide, France, 86000
- CHU De Poitiers
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age > 18 years and ≤ 80 years
- FBSS
- Radicular leg et lumbar pain
- For more than 3 months after one or many spine surgeries
- Mixt pain (radicular leg et lumbar) with Neuropathic status
- Failure of conservative treatment
- Severe uni or bilateral radicular pain > 5 / 10
Exclusion Criteria:
- Age <18 years and> 80 years.
- BMI > 30 kg/m2.
- Back pain that can be treated by surgery (discogenic, vertebral instability, …)
- Contraindication to TCIVA anesthesia under propofol remifentanil
- Psychiatric status
- Cancer
- No signature of informed consent.
- Women of childbearing without contraception
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Target-controlled Intravenous Anaesthesia
Patients have a target controlled intravenous anaesthesia to implant the spinal cord stimulation lead with active cooperation during the surgery.
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Active Comparator: Total anesthesia
Patients have a total anaesthesia to implant the spinal cord stimulation lead without active cooperation during the surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Postoperative paresthesia coverage >= 50% of the lower lumbar determined using a paresthesia cover mapping
Time Frame: 6 months.
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6 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
November 17, 2017
Study Completion (Actual)
November 17, 2017
Study Registration Dates
First Submitted
June 27, 2016
First Submitted That Met QC Criteria
July 1, 2016
First Posted (Estimate)
July 4, 2016
Study Record Updates
Last Update Posted (Actual)
April 8, 2019
Last Update Submitted That Met QC Criteria
April 4, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIVOC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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