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

Failed Back Surgery Syndrome Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02821897
• Other study ID #: AIVOC
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: November 17, 2017

Study information

• Verified date: April 2019
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 17, 2017
• Est. primary completion date: November 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Failed Back Surgery Syndrome

Intervention

Procedure:
• Target-controlled intravenous anaesthesia

• Total anaesthesia

Locations

Country	Name	City	State
France	CHU de Poitiers	Poitiers	Worldwide

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative paresthesia coverage >= 50% of the lower lumbar determined using a paresthesia cover mapping		6 months.