Pain Management After SurgeryPhase 3ADRIATICNCT02904538
Perineural Versus Systemic Dexamethasone to Prolong Regional Anesthesia in Front Foot Surgery
A Phase 3 study testing Dexamethasone and isotonic saline in people with Pain Management After Surgery, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Both perineural and systemic dexamethasone administration allows an increase in analgesic duration of regional anesthesia. There is a lack of data to determine wich route allows a longer analgesic effect. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Management After Surgery
- What is being tested?
- Dexamethasone and isotonic saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 22 Nov 2016to 23 May 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
- front foot surgery with metacarpal osteotomy under regional anesthesia
- >18 years old
- consent to participate in the study
Who cannot join
- refusal to participate
- pregnancy
- feeding
- pre existing neuropathy
- ropivacaine allergy
- paracetamol allergy
Show all 12Show fewer
- liver failure
- cardiac failure
- ketoprofen allergy
- gastric ulcer within the previous year
- tramadol allergy
- history of epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Both perineural and systemic dexamethasone administration allows an increase in analgesic duration of regional anesthesia.
There is a lack of data to determine wich route allows a longer analgesic effect.
This study aims to determine wether perineural dexamethasone allows a longer analgesic duration than systemic route in combination with regional anesthesia (Ropivacaine 0.375%) for front foot surgery.
Read the detailed description
This is a prospective, randomized, double-blind controlled trial.
All Patients undergoing front foot surgery with metacarpal osteotomy will be screened for inclusion in the protocol. All patients without exclusion criteria will be included in the study.
All patients will receive 30cc mixure of Ropivacaine 0,375% in perineural injection and surgery will be performed under regional anesthesia only. If needed, a sedation with midazolam (1mg) will be performed.
The patients will be randomized over 2 groups:
- "Perineural group":
- 1cc (4mg) of dexamethasone will be administrated in perineural injection
- 2.5cc of isotonic saline solution will be administrated in systemic injection
- "Systemic group":
- 1cc of isotonic saline will be administrated in perineural injection
- 2.5cc (10mg) of dexamethasone will be administrated in systemic injection
For both groups perineural injection will be performed at the ankle and the following nerves will be targeted: the tibial nerve, saphenous nerve, the deep fibular nerve, the superficial fibular nerve and the sural nerve.
Post-operative analgesia will be reached with paracetamol (1gr each 6 hours) and Ketoprofen (100mg each 12 hours).
After surgery, patients will be asked to write down the time to the first opioids request during the first 48 hours, maximal pain during the first 48H using a visual analog scale, occurrence of nausea or vomiting, overall satisfaction regarding pain relief management and any significant side effects during the first 7 days.
The primary objective of the study is to determine if perineural dexamethasone is associated with a longer analgesic duration than systemic route in combination with regional anesthesia (Ropivacaine 0.375%) for front foot surgery.
The primary end-point will be time to the first opioids request during the first 48 hours.
- Conditions
- Pain Management After Surgery
- Being tested
- Dexamethasone, isotonic saline
- Keywords
- Dexamethasone, Regional anesthesia, Front foot surgery, Metacarpal osteotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
isotonic salineDrug
| Study group | Role | What they receive |
|---|---|---|
| Perineural group | Experimental | 1cc (4mg) of dexamethasone will be administrated in perineural injection. 2.5cc of isotonic saline solution will be administrated in systemic injection. Receives: Drug: Dexamethasone |
| systemic group | Experimental | 1cc of isotonic saline will be administrated in perineural injection. 2.5cc (10mg) of dexamethasone will be administrated in systemic injection. Receives: Drug: Dexamethasone; Drug: isotonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to the first opioids request
Measured: during the first 48 hours
Secondary outcomes (3)
occurrence of nausea or vomiting
during the first 48 hours
Measured: at day 1
overall satisfaction regarding pain relief management
overall satisfaction regarding pain relief management (using following questionnaire : No pain - Light pain - Moderate pain - Significant pain - Excruciating pain)
Measured: at day 1
any significant side effects
Measured: during the first 7 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study start22 Nov 2016
- Primary completion23 May 2017
- Study completion23 May 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 Pain Management After SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Michel CONSTANTIN, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904538
- Sponsor's protocol ID
- CHU-0277
- Other IDs
- 2016-001341-41, 2016
- Acronym
- ADRIATIC
- Status last verified
- Jun 2017
- First submitted
- 6 Sep 2016
- Last updated
- 16 Jun 2017
- Results posted
- No
Publications
Marty P, Rontes O, Chassery C, Vuillaume C, Basset B, Merouani M, Marquis C, Bataille B, Chaubard M, Mailles MC, Ferre F, Delbos A. Perineural Versus Systemic Dexamethasone in Front-Foot Surgery Under Ankle Block: A Randomized Double-Blind Study. Reg Anesth Pain Med. 2018 Oct;43(7):732-737. doi: 10.1097/AAP.0000000000000769.
PubMed 29630032
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perineural Versus Systemic Dexamethasone to Prolong Regional Anesthesia in Front Foot Surgery
- ClinicalTrials.gov ID
- NCT02904538
- Acronym / sponsor ID
- ADRIATIC / CHU-0277
- Conditions
- Pain Management After Surgery
- Keywords
- Dexamethasone, Regional anesthesia, Front foot surgery, Metacarpal osteotomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 22 Nov 2016 (actual)
- Primary completion
- 23 May 2017 (actual)
- Study completion
- 23 May 2017 (actual)
- First posted
- 19 Sep 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.
Both perineural and systemic dexamethasone administration allows an increase in analgesic duration of regional anesthesia.
There is a lack of data to determine wich route allows a longer analgesic effect.
This study aims to determine wether perineural dexamethasone allows a longer analgesic duration than systemic route in combination with regional anesthesia (Ropivacaine 0.375%) for front foot surgery.
Detailed description
This is a prospective, randomized, double-blind controlled trial.
All Patients undergoing front foot surgery with metacarpal osteotomy will be screened for inclusion in the protocol. All patients without exclusion criteria will be included in the study.
All patients will receive 30cc mixure of Ropivacaine 0,375% in perineural injection and surgery will be performed under regional anesthesia only. If needed, a sedation with midazolam (1mg) will be performed.
The patients will be randomized over 2 groups:
- "Perineural group":
- 1cc (4mg) of dexamethasone will be administrated in perineural injection
- 2.5cc of isotonic saline solution will be administrated in systemic injection
- "Systemic group":
- 1cc of isotonic saline will be administrated in perineural injection
- 2.5cc (10mg) of dexamethasone will be administrated in systemic injection
For both groups perineural injection will be performed at the ankle and the following nerves will be targeted: the tibial nerve, saphenous nerve, the deep fibular nerve, the superficial fibular nerve and the sural nerve.
Post-operative analgesia will be reached with paracetamol (1gr each 6 hours) and Ketoprofen (100mg each 12 hours).
After surgery, patients will be asked to write down the time to the first opioids request during the first 48 hours, maximal pain during the first 48H using a visual analog scale, occurrence of nausea or vomiting, overall satisfaction regarding pain relief management and any significant side effects during the first 7 days.
The primary objective of the study is to determine if perineural dexamethasone is associated with a longer analgesic duration than systemic route in combination with regional anesthesia (Ropivacaine 0.375%) for front foot surgery.
The primary end-point will be time to the first opioids request during the first 48 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perineural group | Experimental | Drug: Dexamethasone1cc (4mg) of dexamethasone will be administrated in perineural injection. 2.5cc of isotonic saline solution will be administrated in systemic injection. |
| systemic group | Experimental | Drug: Dexamethasone, Drug: isotonic saline1cc of isotonic saline will be administrated in perineural injection. 2.5cc (10mg) of dexamethasone will be administrated in systemic injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- front foot surgery with metacarpal osteotomy under regional anesthesia
- >18 years old
- consent to participate in the study
Key exclusion criteria (12 listed)
- refusal to participate
- pregnancy
- feeding
- pre existing neuropathy
- ropivacaine allergy
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 |
|---|---|---|
| Dexamethasone | Drug | Perineural group, systemic group |
| isotonic saline | Drug | systemic group |
Primary outcome
time to the first opioids request
Time frame: during the first 48 hours
3 secondary outcomes
occurrence of nausea or vomiting
Time frame: at day 1
overall satisfaction regarding pain relief management
Time frame: at day 1
any significant side effects
Time frame: during the first 7 days after surgery.
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 16 Jun 2017.
- Derived from this study: PubMed 29630032Marty P, Rontes O, Chassery C, Vuillaume C, Basset B, Merouani M, Marquis C, Bataille B, Chaubard M, Mailles MC, Ferre F, Delbos A. Perineural Versus Systemic Dexamethasone in Front-Foot Surgery Under Ankle Block: A Randomized Double-Blind Study. Reg Anesth Pain Med. 2018 Oct;43(7):732-737. doi: 10.1097/AAP.0000000000000769.
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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.
Jean-Michel CONSTANTIN principal investigator
University Hospital, Clermont-Ferrand
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 Dexamethasone and isotonic saline in people with Pain Management After Surgery, run by University Hospital, Clermont-Ferrand 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 3 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 16 Jun 2017. 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.
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?
time to the first opioids request (time frame: during the first 48 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 NCT02904538, 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 16 Jun 2017.