Value of Target-controlled Intravenous Anaesthesia (TCIVA) in Spinal Cord Stimulation (AIVOC)

Poitiers University Hospital

Status: Completed

Conditions: Failed Back Surgery Syndrome

Treatments: Procedure: Target-controlled intravenous anaesthesia; Procedure: Total anaesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT02821897

AIVOC

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15 participants in 2 patient groups

Target-controlled Intravenous Anaesthesia

Experimental group

Description:

Patients have a target controlled intravenous anaesthesia to implant the spinal cord stimulation lead with active cooperation during the surgery.

Treatment:

Procedure: Target-controlled intravenous anaesthesia

Total anesthesia

Active Comparator group

Description:

Patients have a total anaesthesia to implant the spinal cord stimulation lead without active cooperation during the surgery.

Treatment:

Procedure: Total anaesthesia