Complex Regional Pain SyndromeANI-ALGONCT02663284
Evaluation of the Physiodoloris Pain Monitor in Patients With Complex Regional Pain Syndrome
A study testing Ropivacaine 0.5% in people with Complex Regional Pain Syndrome, run by Hopital Foch at 1 site in France.
Trial summary
A French University team (M. Jeanne, MD, and M. LOGIER, Ph D) have developed a pain assessment tool based on the analysis of the variability heart rate which evaluates the Analgesia Nociception Index (ANI). This index is intended to give a quantification of pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Regional Pain Syndrome
- What is being tested?
- Ropivacaine 0.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2012to Mar 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients suffering from a Complex Regional Pain Syndrome of the upper or lower limb
Who cannot join
- contra-indication of a nerve block,
- contra-indication of the use of the pain monitor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Non-invasive Monitor of Physiodoloris Pain in Patients With Complex Regional Pain Syndrome Treated by Nerve Block (Prospective Monocenter Study)
A French University team (M. Jeanne, MD, and M. LOGIER, Ph D) have developed a pain assessment tool based on the analysis of the variability heart rate which evaluates the Analgesia Nociception Index (ANI). This index is intended to give a quantification of pain.
The aim of the present study is to assess the validity of the ANI parameter in patients with Complex Regional Pain Syndrome treated with a nerve block (reversible pain).
- Conditions
- Complex Regional Pain Syndrome
- Being tested
- Ropivacaine 0.5%
- Medical subject headings
- Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.5%Drug
Ropivacaine is used to performed the perineural block
| Study group | Role | What they receive |
|---|---|---|
| Perineural block | Experimental | Perineural block with Ropivacaine 0.5% Receives: Drug: Ropivacaine 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of ANI before the peri-neural block
ANI is recorded before each nerve block
Measured: 5 minutes
Evaluation of pain before the peri-neural block
Pain score is recorded before each nerve block
Measured: 5 minutes
Secondary outcomes (2)
Evaluation of ANI after the peri-neural block
ANI is recorded after each nerve block
Measured: 10 minutes
Evaluation of pain after the peri-neural block
Pain score is recorded after each nerve block
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startApr 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Regional Pain SyndromeStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Fischler, Study chair, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663284
- Sponsor's protocol ID
- 2011/67
- Other IDs
- 2011-A01676-35
- Acronym
- ANI-ALGO
- Status last verified
- Nov 2016
- First submitted
- 29 Sep 2015
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Non-invasive Monitor of Physiodoloris Pain in Patients With Complex Regional Pain Syndrome Treated by Nerve Block (Prospective Monocenter Study)
- ClinicalTrials.gov ID
- NCT02663284
- Acronym / sponsor ID
- ANI-ALGO / 2011/67
- Conditions
- Complex Regional Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 26 Jan 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.
A French University team (M. Jeanne, MD, and M. LOGIER, Ph D) have developed a pain assessment tool based on the analysis of the variability heart rate which evaluates the Analgesia Nociception Index (ANI). This index is intended to give a quantification of pain.
The aim of the present study is to assess the validity of the ANI parameter in patients with Complex Regional Pain Syndrome treated with a nerve block (reversible pain).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perineural block | Experimental | Drug: Ropivacaine 0.5%Perineural block with Ropivacaine 0.5% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients suffering from a Complex Regional Pain Syndrome of the upper or lower limb
Key exclusion criteria (2 listed)
- contra-indication of a nerve block,
- contra-indication of the use of the pain monitor
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 |
|---|---|---|
| Ropivacaine 0.5%Ropivacaine is used to performed the perineural block | Drug | Perineural block |
Primary outcome
Evaluation of ANI before the peri-neural block
Time frame: 5 minutes
ANI is recorded before each nerve block
Evaluation of pain before the peri-neural block
Time frame: 5 minutes
Pain score is recorded before each nerve block
2 secondary outcomes
Evaluation of ANI after the peri-neural block
Time frame: 10 minutes
Evaluation of pain after the peri-neural block
Time frame: 10 minutes
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 3 Nov 2016.
Related trials for Complex Regional Pain Syndrome
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Recruiting
The Effectiveness of Conservative Treatment in Patients With Complex Regional Pain Syndrome.
CRPS (Complex Regional Pain Syndromes)
RecruitingPhase 3
Phase 3, Open-Label Extension Study of AMBTX-01 (Neridronate) for Complex Regional Pain Syndrome Type 1
Complex Regional Pain Syndrome Type I
Active, not recruiting
Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
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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.
Marc Fischler study chair
Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine 0.5% in people with Complex Regional Pain Syndrome, run by Hopital Foch 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 1 inclusion and 2 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 3 Nov 2016. 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?
Evaluation of ANI before the peri-neural block (time frame: 5 minutes). The study lists 2 primary outcomes in all. 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 3 Nov 2016.