Postoperative PainPhase 3ADEXANCT02862327
Intravenous Dexamethasone for Ropivacaine Axillary Block
A Phase 3 study testing intravenous dexamethasone, perineural ropivacaine and ultrasound guidance in people with Postoperative Pain and Anesthesia, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Prospective monocentric double-blind controlled randomised trial Aim is to assess prolonged postsurgical analgesia by intravenous dexamethasone versus intravenous placebo, after ultrasound guided axillary brachial plexus block Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Anesthesia, Forearm Injuries
- What is being tested?
- intravenous dexamethasone, perineural ropivacaine and ultrasound guidance
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2016to 16 Sep 2017
- 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
- ASA 1,2 et 3
- surgery under axillary brachial plexus block
- aged >18 years
- signed information consent
Who cannot join
- impaired coagulation
- contraindication to regional anesthesia or technical impossibility
- opioids or pain killers abuse or addiction
- steroids consumption in the past 6 months
- dementia or under administrative supervision
- delay of surgery to short to allow regional anesthesia
Show all 10Show fewer
- pregnancy and breastfeeding
- allergy and contraindication to dexamethasone or ropivacaine
- anticipated bad observation of treatment
- patient enrolled in another trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Dexamethasone Versus Placebo for Ultrasound Guided Axillary Brachial Plexus Block With Ropivacaine: Randomised, Controlled, Clinical Trial
Prospective monocentric double-blind controlled randomised trial Aim is to assess prolonged postsurgical analgesia by intravenous dexamethasone versus intravenous placebo, after ultrasound guided axillary brachial plexus block
- Conditions
- Postoperative Pain, Anesthesia, Forearm Injuries
- Being tested
- intravenous dexamethasone, intravenous placebo, perineural ropivacaine, ultrasound guidance
- Keywords
- anaesthetic techniques, regional anesthesia, brachial plexus block, Local Anesthetic, ropivacaine, analgesia, steroid, dexamethasone, placebo, adjuvant, ultrasound guided
- Medical subject headings
- Pain, Postoperative, Forearm Injuries, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous dexamethasoneDrug
Also called DEXAMETHASONE MYLAN code UCD 9223084 3400892230849
intravenous injection of dexamethasone
intravenous placeboDrug
intravenous injection of placebo
perineural ropivacaineDrug
brachial plexus block with perineural injection of Ropivacaine in the axillary fossa
ultrasound guidanceOther
ultrasound guidance for brachial plexus block in the axillary fossa
| Study group | Role | What they receive |
|---|---|---|
| intravenous dexamethasone | Active comparator | intravenous injection of 8mg (2ml) of dexamethasone during regional anesthesia Receives: Drug: intravenous dexamethasone; Drug: perineural ropivacaine; Other: ultrasound guidance |
| intravenous placebo | Placebo comparator | intravenous injection of 2ml of NaCl 0.9% during regional anesthesia Receives: Drug: intravenous placebo; Drug: perineural ropivacaine; Other: ultrasound guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesia duration after axillary brachial plexus block
Measured: time to first pain at surgical site, an average of 24 hours
Secondary outcomes (3)
Motor block duration after axillary brachial plexus block Safety
Measured: up to block recovery, an average of 24 hours
Sensory block duration after axillary brachial plexus block
Measured: up to block recovery, an average of 24 hours
incidence of adverse event
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study start1 Dec 2016
- Primary completion16 Mar 2017
- Study completion16 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862327
- Sponsor's protocol ID
- P/2015/275
- Acronym
- ADEXA
- Status last verified
- Oct 2017
- First submitted
- 22 Jul 2016
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Clement JC, Besch G, Puyraveau M, Grelet T, Ferreira D, Vettoretti L, Pili-Floury S, Samain E, Berthier F. Clinical effectiveness of single dose of intravenous dexamethasone on the duration of ropivacaine axillary brachial plexus block: the randomized placebo-controlled ADEXA trial. Reg Anesth Pain Med. 2019 Mar;44(3):e100035. doi: 10.1136/rapm-2018-100035.
PubMed 30777900
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Dexamethasone Versus Placebo for Ultrasound Guided Axillary Brachial Plexus Block With Ropivacaine: Randomised, Controlled, Clinical Trial
- ClinicalTrials.gov ID
- NCT02862327
- Acronym / sponsor ID
- ADEXA / P/2015/275
- Conditions
- Postoperative Pain, Anesthesia, Forearm Injuries
- Keywords
- anaesthetic techniques, regional anesthesia, brachial plexus block, Local Anesthetic, ropivacaine, analgesia, steroid, dexamethasone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 16 Mar 2017 (actual)
- Study completion
- 16 Sep 2017 (actual)
- First posted
- 11 Aug 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.
Prospective monocentric double-blind controlled randomised trial Aim is to assess prolonged postsurgical analgesia by intravenous dexamethasone versus intravenous placebo, after ultrasound guided axillary brachial plexus block
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intravenous dexamethasone | Active comparator | Drug: intravenous dexamethasone, Drug: perineural ropivacaine, Other: ultrasound guidanceintravenous injection of 8mg (2ml) of dexamethasone during regional anesthesia |
| intravenous placebo | Placebo comparator | Drug: intravenous placebo, Drug: perineural ropivacaine, Other: ultrasound guidanceintravenous injection of 2ml of NaCl 0.9% during 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)
- ASA 1,2 et 3
- surgery under axillary brachial plexus block
- aged >18 years
- signed information consent
Key exclusion criteria (10 listed)
- impaired coagulation
- contraindication to regional anesthesia or technical impossibility
- opioids or pain killers abuse or addiction
- steroids consumption in the past 6 months
- 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 dexamethasoneAlso: DEXAMETHASONE MYLAN code UCD 9223084 3400892230849intravenous injection of dexamethasone | Drug | intravenous dexamethasone |
| intravenous placebointravenous injection of placebo | Drug | intravenous placebo |
| perineural ropivacainebrachial plexus block with perineural injection of Ropivacaine in the axillary fossa | Drug | intravenous dexamethasone, intravenous placebo |
| ultrasound guidanceultrasound guidance for brachial plexus block in the axillary fossa | Other | intravenous dexamethasone, intravenous placebo |
Primary outcome
Analgesia duration after axillary brachial plexus block
Time frame: time to first pain at surgical site, an average of 24 hours
3 secondary outcomes
Motor block duration after axillary brachial plexus block Safety
Time frame: up to block recovery, an average of 24 hours
Sensory block duration after axillary brachial plexus block
Time frame: up to block recovery, an average of 24 hours
incidence of adverse event
Time frame: 6 month
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 31 Jan 2018.
- Derived from this study: PubMed 30777900Clement JC, Besch G, Puyraveau M, Grelet T, Ferreira D, Vettoretti L, Pili-Floury S, Samain E, Berthier F. Clinical effectiveness of single dose of intravenous dexamethasone on the duration of ropivacaine axillary brachial plexus block: the randomized placebo-controlled ADEXA trial. Reg Anesth Pain Med. 2019 Mar;44(3):e100035. doi: 10.1136/rapm-2018-100035.
- Individual participant dataSharing planned: No
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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 Phase 3 study testing intravenous dexamethasone, perineural ropivacaine and ultrasound guidance in people with Postoperative Pain and Anesthesia, 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 10 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 31 Jan 2018. 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?
Analgesia duration after axillary brachial plexus block (time frame: time to first pain at surgical site, an average of 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02862327, which also lists 1 linked publication.
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 31 Jan 2018.