NCT02821897

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 4, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2017

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

4.7 years

First QC Date

June 27, 2016

Last Update Submit

April 4, 2019

Conditions

Failed Back Surgery Syndrome

Outcome Measures

Primary Outcomes (1)

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

    6 months.

Study Arms (2)

Target-controlled Intravenous Anaesthesia

EXPERIMENTAL

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

Procedure: Target-controlled intravenous anaesthesia

Total anesthesia

ACTIVE COMPARATOR

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

Procedure: Total anaesthesia

Interventions

Target-controlled intravenous anaesthesiaPROCEDURE
Target-controlled Intravenous Anaesthesia
Total anaesthesiaPROCEDURE
Total anesthesia

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Poitiers

Poitiers, Worldwide, 86000, France

Location

MeSH Terms

Conditions

Failed Back Surgery Syndrome

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsBack PainPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2016

First Posted

July 4, 2016

Study Start

March 1, 2013

Primary Completion

November 17, 2017

Study Completion

November 17, 2017

Last Updated

April 8, 2019

Record last verified: 2019-04

Locations

FR(1)