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

NCT ID: NCT02821897

Last Updated: 2019-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2017-11-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Failed Back Surgery Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Target-controlled Intravenous Anaesthesia

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

Group Type EXPERIMENTAL

Target-controlled intravenous anaesthesia

Intervention Type PROCEDURE

Total anesthesia

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

Group Type ACTIVE_COMPARATOR

Total anaesthesia

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Target-controlled intravenous anaesthesia

Intervention Type PROCEDURE

Total anaesthesia

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU de Poitiers

Poitiers, Worldwide, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AIVOC

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.