Failed Back Surgery SyndromeAIVOCNCT02821897
Value of Target-controlled Intravenous Anaesthesia (TCIVA) in Spinal Cord Stimulation
A study testing Total anaesthesia in people with Failed Back Surgery Syndrome, run by Poitiers University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Failed Back Surgery Syndrome
- What is being tested?
- Total anaesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to 17 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Failed Back Surgery Syndrome
- Being tested
- Target-controlled intravenous anaesthesia, Total anaesthesia
- Medical subject headings
- Failed Back Surgery Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Target-controlled intravenous anaesthesiaProcedure or surgery
Total anaesthesiaProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Total anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative paresthesia coverage >= 50% of the lower lumbar determined using a paresthesia cover mapping
Measured: 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study startMar 2013
- Primary completion17 Nov 2017
- Study completion17 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failed Back Surgery SyndromeStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821897
- Sponsor's protocol ID
- AIVOC
- Acronym
- AIVOC
- Status last verified
- Apr 2019
- First submitted
- 27 Jun 2016
- Last updated
- 8 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02821897
- Acronym / sponsor ID
- AIVOC / AIVOC
- Conditions
- Failed Back Surgery Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- 17 Nov 2017 (actual)
- Study completion
- 17 Nov 2017 (actual)
- First posted
- 4 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Target-controlled Intravenous Anaesthesia | Experimental | Procedure: Target-controlled intravenous anaesthesiaPatients have a target controlled intravenous anaesthesia to implant the spinal cord stimulation lead with active cooperation during the surgery. |
| Total anesthesia | Active comparator | Procedure: Total anaesthesiaPatients have a total anaesthesia to implant the spinal cord stimulation lead without active cooperation during the surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Target-controlled intravenous anaesthesia | Procedure or surgery | Target-controlled Intravenous Anaesthesia |
| Total anaesthesia | Procedure or surgery | Total anesthesia |
Primary outcome
Postoperative paresthesia coverage >= 50% of the lower lumbar determined using a paresthesia cover mapping
Time frame: 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total anaesthesia in people with Failed Back Surgery Syndrome, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative paresthesia coverage >= 50% of the lower lumbar determined using a paresthesia cover mapping (time frame: 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019.