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

Not Applicable

Completed

• Conditions: Failed Back Surgery Syndrome
• Interventions: Procedure: Target-controlled intravenous anaesthesia; Procedure: Total anaesthesia

• Registration Number: NCT02821897
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-07-01
• Study First Posted: 2016-07-04
• Primary Completion: 2017-11-17
• Study Completion: 2017-11-17
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-04
• Last Update Posted: 2019-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Target-controlled Intravenous Anaesthesia	Target-controlled intravenous anaesthesia	Patients have a target controlled intravenous anaesthesia to implant the spinal cord stimulation lead with active cooperation during the surgery.
Total anesthesia	Total anaesthesia	Patients have a total anaesthesia to implant the spinal cord stimulation lead without active cooperation during the surgery.

Primary Outcome Measures

Name	Time	Method
Postoperative paresthesia coverage >= 50% of the lower lumbar determined using a paresthesia cover mapping	6 months.

Trial Locations

Locations (1)

CHU de Poitiers; 🇫🇷 Poitiers, Worldwide, France