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

April 4, 2019 updated by: Poitiers University Hospital

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 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 Overview

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Worldwide
      • Poitiers, Worldwide, France, 86000
        • CHU De Poitiers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Target-controlled Intravenous Anaesthesia
Patients have a target controlled intravenous anaesthesia to implant the spinal cord stimulation lead with active cooperation during the surgery.
Active Comparator: Total anesthesia
Patients have a total anaesthesia to implant the spinal cord stimulation lead without active cooperation during the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative paresthesia coverage >= 50% of the lower lumbar determined using a paresthesia cover mapping
Time Frame: 6 months.
6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

November 17, 2017

Study Completion (Actual)

November 17, 2017

Study Registration Dates

First Submitted

June 27, 2016

First Submitted That Met QC Criteria

July 1, 2016

First Posted (Estimate)

July 4, 2016

Study Record Updates

Last Update Posted (Actual)

April 8, 2019

Last Update Submitted That Met QC Criteria

April 4, 2019

Last Verified

April 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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