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

Poitiers University Hospital15 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Failed Back Surgery Syndrome

Interventions

Target-controlled intravenous anaesthesiaPROCEDURE

Total anaesthesiaPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU de Poitiers

Poitiers, Worldwide, France

Outcomes

Primary Outcomes

Postoperative paresthesia coverage >= 50% of the lower lumbar determined using a paresthesia cover mapping

Time frame: 6 months.

Data from ClinicalTrials.gov

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