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OpenTrials
Completed

NCT Number: NCT02821897

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

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.

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Key information

Conditions

Failed Back Surgery Syndrome Back Pain Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Poitiers

Poitiers, Worldwide, 86000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Target-controlled intravenous anaesthesia

Procedure

Total anaesthesia

Procedure

Primary outcomes

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

    Time frame: 6 months.

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study 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

Acronym: AIVOC

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 4, 2016
Registry last updated
Apr 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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