Anesthesia, ConductionPhase 3AxiRopiDexaNCT03688269
Minimal Effective Concentration (EC90) of Ropivacaine
A Phase 3 study testing Intravenous dexamethasone, Intravenous saline and Perineural ropivacaine in people with Anesthesia, Conduction and Ropivacaine, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Prospective up and down sequential evaluation of the minimal effective concentration of perineural ropivacaine for 90% success in axillary brachial plexus block with the injection of intravenous dexamethasone or saline placebo during regional anesthesia performance Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Conduction, Ropivacaine, Dexamethasone
- What is being tested?
- Intravenous dexamethasone, Intravenous saline and Perineural ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 1 siteFrance
- Study dates
- 5 Oct 2018to 4 May 2020
- Phase
- Phase 3
- 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
- 18 years old or older
- ASA Score 1,2 et 3 (American Society of Anesthesiologists Score)
- surgery under axillary brachial plexus block
- signed information consent
Who cannot join
- pregnancy and breastfeeding
- contraindication to regional anesthesia or technical impossibility
- impaired coagulation
- delay of surgery to short to allow regional anesthesia
- dementia or under administrative supervision
- allergy and contraindication to dexamethasone or ropivacaine
Show all 12Show fewer
- total dose of ropivacaine higher than 3 mg / kg (recommended dose for upper limb regional anesthesia)
- opioids or pain killers abuse or addiction
- steroids consumption in the past 6 months
- surgery estimated to be greater than 4 hours
- anticipated bad observation of treatment
- patient enrolled in another trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Minimal Effective Concentration (EC90) of Ropivacaine in Axillary Brachial Plexus Block With Intravenous Dexamethasone or Saline Injection
Prospective up and down sequential evaluation of the minimal effective concentration of perineural ropivacaine for 90% success in axillary brachial plexus block with the injection of intravenous dexamethasone or saline placebo during regional anesthesia performance
Read the detailed description
ropivacaine concentration determined by up and down sequential method dexamethasone or saline placebo determined by randomisation
- Being tested
- Intravenous dexamethasone, Intravenous saline, Perineural ropivacaine
- Keywords
- regional anesthesia, dexamethasone, ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous dexamethasoneDrug
Intravenous injection of 8mg/2ml dexamethasone
Intravenous salineDrug
Intravenous injection of 2ml Saline 0.9%
Perineural ropivacaineDrug
Perineural injection of 20ml ropivacaine with adjustment of the concentration determined by sequential up and down method
| Study group | Role | What they receive |
|---|---|---|
| Intravenous dexamethasone | Experimental | Axillary Brachial Plexus Block with perineural Ropivacaine. Concentration determined by sequential up and down method.
Intravenous injection of 8mg/2ml Dexamethasone during the regional anesthesia Receives: Drug: Intravenous dexamethasone; Drug: Perineural ropivacaine |
| Intravenous saline | Placebo comparator | Axillary Brachial Plexus Block with perineural Ropivacaine. Concentration determined by sequential up and down method.
Intravenous injection of 2ml Saline 0.9% during the regional anesthesia Receives: Drug: Intravenous saline; Drug: Perineural ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Effectiveness of regional anesthesia at 30min
Ability to perform surgery under regional anaesthesia without supplementary anaesthesia
Measured: Time of surgery
Secondary outcomes (8)
time between regional anesthesia and surgical incision
time between the end of regional anesthesia and the beginning of surgical incision
Measured: Time of surgery
Effectiveness of regional anaesthesia on Pin-Prick sense
Defined by a loss of pain sensation at the pinprick test at 30min after the end of regional anaesthesia
Measured: Time of anaesthesia
Effectiveness of regional anaesthesia on cold sensation
Defined by a loss of sensation of cold application on skin at 30min after the end of regional anaesthesia
Measured: Time of anaesthesia
Effectiveness of regional anaesthesia on motor function
Defined by a paresis at 30min after the end of regional anaesthesia (modified bromage score)
Measured: Time of anaesthesia
recovery of regional anesthesia: pain
time to first pain sensation in the surgical wound after the end of regional anaesthesia
Measured: first 48h
recovery of regional anesthesia: motor
time to motor recovery of the arm after the end of regional anaesthesia
Measured: first 48h
recovery of regional anesthesia: sensory
time to sensory recovery of the arm after the end of regional anaesthesia
Measured: first 48h
complication related to regional anesthesia and/or intravenous dexamethasone
any complication during the first 6 month after the surgery
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start5 Oct 2018
- Primary completion4 Nov 2019
- Study completion4 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, ConductionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- allocation to one of the 2 arm after randomization
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francis BERTHIER, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688269
- Sponsor's protocol ID
- P/2018/384
- Acronym
- AxiRopiDexa
- Status last verified
- Dec 2020
- First submitted
- 14 Sep 2018
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD sharing in progress in the institution
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Minimal Effective Concentration (EC90) of Ropivacaine in Axillary Brachial Plexus Block With Intravenous Dexamethasone or Saline Injection
- ClinicalTrials.gov ID
- NCT03688269
- Acronym / sponsor ID
- AxiRopiDexa / P/2018/384
- Keywords
- regional anesthesia, dexamethasone, ropivacaine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 5 Oct 2018 (actual)
- Primary completion
- 4 Nov 2019 (actual)
- Study completion
- 4 May 2020 (actual)
- First posted
- 28 Sep 2018 (actual)
- 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.
Prospective up and down sequential evaluation of the minimal effective concentration of perineural ropivacaine for 90% success in axillary brachial plexus block with the injection of intravenous dexamethasone or saline placebo during regional anesthesia performance
Detailed description
ropivacaine concentration determined by up and down sequential method dexamethasone or saline placebo determined by randomisation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- allocation to one of the 2 arm after randomization
| Arm | Type | Receives |
|---|---|---|
| Intravenous dexamethasone | Experimental | Drug: Intravenous dexamethasone, Drug: Perineural ropivacaineAxillary Brachial Plexus Block with perineural Ropivacaine. Concentration determined by sequential up and down method. Intravenous injection of 8mg/2ml Dexamethasone during the regional anesthesia |
| Intravenous saline | Placebo comparator | Drug: Intravenous saline, Drug: Perineural ropivacaineAxillary Brachial Plexus Block with perineural Ropivacaine. Concentration determined by sequential up and down method. Intravenous injection of 2ml Saline 0.9% during the regional anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old or older
- ASA Score 1,2 et 3 (American Society of Anesthesiologists Score)
- surgery under axillary brachial plexus block
- signed information consent
Key exclusion criteria (12 listed)
- pregnancy and breastfeeding
- contraindication to regional anesthesia or technical impossibility
- impaired coagulation
- delay of surgery to short to allow regional anesthesia
- dementia or under administrative supervision
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 |
|---|---|---|
| Intravenous dexamethasoneIntravenous injection of 8mg/2ml dexamethasone | Drug | Intravenous dexamethasone |
| Intravenous salineIntravenous injection of 2ml Saline 0.9% | Drug | Intravenous saline |
| Perineural ropivacainePerineural injection of 20ml ropivacaine with adjustment of the concentration determined by sequential up and down method | Drug | Intravenous dexamethasone, Intravenous saline |
Primary outcome
Surgical Effectiveness of regional anesthesia at 30min
Time frame: Time of surgery
Ability to perform surgery under regional anaesthesia without supplementary anaesthesia
8 secondary outcomes
time between regional anesthesia and surgical incision
Time frame: Time of surgery
Effectiveness of regional anaesthesia on Pin-Prick sense
Time frame: Time of anaesthesia
Effectiveness of regional anaesthesia on cold sensation
Time frame: Time of anaesthesia
Effectiveness of regional anaesthesia on motor function
Time frame: Time of anaesthesia
recovery of regional anesthesia: pain
Time frame: first 48h
recovery of regional anesthesia: motor
Time frame: first 48h
recovery of regional anesthesia: sensory
Time frame: first 48h
complication related to regional anesthesia and/or intravenous dexamethasone
Time frame: month 6
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 21 Dec 2020.
- Individual participant dataSharing planned: Undecided. IPD sharing in progress in the institution
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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.
Francis BERTHIER principal investigator
Centre Hospitalier Universitaire de Besancon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravenous dexamethasone, Intravenous saline and Perineural ropivacaine in people with Anesthesia, Conduction and Ropivacaine, run by Centre Hospitalier Universitaire de Besancon 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 4 inclusion and 12 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 21 Dec 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Surgical Effectiveness of regional anesthesia at 30min (time frame: Time of surgery). 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 21 Dec 2020.