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

Primary Purpose

Failed Back Surgery Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Target-controlled intravenous anaesthesia
Total anaesthesia
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Failed Back Surgery Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU de Poitiers

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Target-controlled Intravenous Anaesthesia

Total anesthesia

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 27, 2016
Last Updated
April 4, 2019
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02821897
Brief Title
Value of Target-controlled Intravenous Anaesthesia (TCIVA) in Spinal Cord Stimulation
Acronym
AIVOC
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
November 17, 2017 (Actual)
Study Completion Date
November 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failed Back Surgery Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Target-controlled Intravenous Anaesthesia
Arm Type
Experimental
Arm Description
Patients have a target controlled intravenous anaesthesia to implant the spinal cord stimulation lead with active cooperation during the surgery.
Arm Title
Total anesthesia
Arm Type
Active Comparator
Arm Description
Patients have a total anaesthesia to implant the spinal cord stimulation lead without active cooperation during the surgery.
Intervention Type
Procedure
Intervention Name(s)
Target-controlled intravenous anaesthesia
Intervention Type
Procedure
Intervention Name(s)
Total anaesthesia
Primary Outcome Measure Information:
Title
Postoperative paresthesia coverage >= 50% of the lower lumbar determined using a paresthesia cover mapping
Time Frame
6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU de Poitiers
City
Poitiers
State/Province
Worldwide
ZIP/Postal Code
86000
Country
France

12. IPD Sharing Statement

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