Failed Back Surgery Syndrome
Conditions
Brief summary
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.
Interventions
PROCEDURETarget-controlled intravenous anaesthesia
PROCEDURETotal anaesthesia
Sponsors
Poitiers University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative paresthesia coverage >= 50% of the lower lumbar determined using a paresthesia cover mapping | 6 months. |
Countries
France
Outcome results
None listed