Anesthesia, ConductionPhase 3NCT02864602
IV Dexamethasone for Prolongation of Peripheral Nerve Block
A Phase 3 study testing IV dexamethasone in people with Anesthesia, Conduction, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is a volunteer study examining the effect of different doses of IV dexamethasone on prolongation of median nerve block in the forearm. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Conduction
- What is being tested?
- IV dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- 12 Nov 2016to 20 Feb 2018
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA 1 (normal healthy) volunteers.
- 18 - 50 years of age.
- 60 - 100kg weight.
- English speaking.
- Female volunteers of childbearing potential will be required to provide a negative pregnancy test before being allowed to participate.
- Females of child bearing potential must be willing to use medically acceptable birth control methods between study interventions and for a minimum of 2 weeks following the second nerve block.
Who cannot join
- Medical disorders (including bleeding disorders).
- Use of systemic steroids within 2 weeks of the study, prescription medications, live viral vaccines or any recreational drug use.
- Hypersensitivity to bupivacaine, dexamethasone or any component of saline.
- Contraindication to regional anesthetic block.
- Inability to provide informed consent.
- Baseline abnormality of hand sensation or motor function.
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- Pregnancy / breast feeding.
- Individuals with mental health disorders (for example bipolar disorder or depression).
- Individuals with cataracts or glaucoma.
- Any known contraindication to IV dexamethasone as per the product monograph - bacteremia and systemic fungal infections, hypersensitivity to any of the products components, gastric and duodenal ulcers, certain viral infections i.e. varicella herpes genitalis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Volunteer Study to Determine the Optimal Dose of IV Dexamethasone Required for Prolongation of Peripheral Nerve Block
This is a volunteer study examining the effect of different doses of IV dexamethasone on prolongation of median nerve block in the forearm.
Read the detailed description
18 healthy volunteers aged 18-50 will be recruited (6 patients in each dosing group). Each volunteer will receive two forearm median nerve blocks separated by a two week washout period. One block will be conducted alongside an infusion of normal saline (control). The other block will be conducted alongside a randomised dose of IV dexamethasone (2, 4 or 8mg). The order of these interventions will be random. Blocks will be assessed quantitatively with cold and sharp sensation, electrical stimulation, quantitative sensory testing (thermal tolerance) and grip strength dynamometry. Measures or sensory and motor block including onset, intensity and duration will be compared between dosing groups.
- Conditions
- Anesthesia, Conduction
- Being tested
- IV dexamethasone
- Keywords
- Regional anesthesia, Adjuvant, Dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV dexamethasoneDrug
Also called Dexamethasone sodium phosphate injection USP
An infusion of IV dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone 2mg | Experimental | The experimental intervention in this arm will be an IV infusion of 2mg of dexamethasone. Volunteers will also have a cross-over placebo comparator (saline infusion). Receives: Drug: IV dexamethasone |
| Dexamethasone 4mg | Experimental | The experimental intervention in this arm will be an IV infusion of 4mg of dexamethasone. Volunteers will also have a cross-over placebo comparator (saline infusion). Receives: Drug: IV dexamethasone |
| Dexamethasone 8mg | Experimental | The experimental intervention in this arm will be an IV infusion of 8mg of dexamethasone. Volunteers will also have a cross-over placebo comparator (saline infusion). Receives: Drug: IV dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of sensory anesthesia and analgesia following median nerve block
Measured: This will be assessed for up to 12 hours following block
Secondary outcomes (2)
The duration of motor block following median nerve block
Measured: This will be assessed for up to 12 hours following block
Side effects related to nerve block or IV infusion of dexamethasone
Measured: Volunteers will be phoned at 24-36 hrs and then 7-10 days to ensure full resolution of the block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study start12 Nov 2016
- Primary completion20 Feb 2018
- Study completion20 Feb 2018
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 Anesthesia, ConductionStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864602
- Sponsor's protocol ID
- 15-5049-A
- Status last verified
- Jan 2019
- First submitted
- 9 Aug 2016
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Short A, El-Boghdadly K, Clarke H, Komaba T, Jin R, Chin KJ, Chan V. Effect of intravenous dexamethasone on the anaesthetic characteristics of peripheral nerve block: a double-blind, randomised controlled, dose-response volunteer study. Br J Anaesth. 2020 Jan;124(1):92-100. doi: 10.1016/j.bja.2019.08.029. Epub 2019 Nov 9.
PubMed 31711605
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Volunteer Study to Determine the Optimal Dose of IV Dexamethasone Required for Prolongation of Peripheral Nerve Block
- ClinicalTrials.gov ID
- NCT02864602
- Acronym / sponsor ID
- 15-5049-A
- Conditions
- Anesthesia, Conduction
- Keywords
- Regional anesthesia, Adjuvant, Dexamethasone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 12 Nov 2016 (actual)
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 20 Feb 2018 (actual)
- First posted
- 12 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.
This is a volunteer study examining the effect of different doses of IV dexamethasone on prolongation of median nerve block in the forearm.
Detailed description
18 healthy volunteers aged 18-50 will be recruited (6 patients in each dosing group). Each volunteer will receive two forearm median nerve blocks separated by a two week washout period. One block will be conducted alongside an infusion of normal saline (control). The other block will be conducted alongside a randomised dose of IV dexamethasone (2, 4 or 8mg). The order of these interventions will be random. Blocks will be assessed quantitatively with cold and sharp sensation, electrical stimulation, quantitative sensory testing (thermal tolerance) and grip strength dynamometry. Measures or sensory and motor block including onset, intensity and duration will be compared between dosing groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone 2mg | Experimental | Drug: IV dexamethasoneThe experimental intervention in this arm will be an IV infusion of 2mg of dexamethasone. Volunteers will also have a cross-over placebo comparator (saline infusion). |
| Dexamethasone 4mg | Experimental | Drug: IV dexamethasoneThe experimental intervention in this arm will be an IV infusion of 4mg of dexamethasone. Volunteers will also have a cross-over placebo comparator (saline infusion). |
| Dexamethasone 8mg | Experimental | Drug: IV dexamethasoneThe experimental intervention in this arm will be an IV infusion of 8mg of dexamethasone. Volunteers will also have a cross-over placebo comparator (saline infusion). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- ASA 1 (normal healthy) volunteers.
- 18 - 50 years of age.
- 60 - 100kg weight.
- English speaking.
- Female volunteers of childbearing potential will be required to provide a negative pregnancy test before being allowed to participate.
Key exclusion criteria (10 listed)
- Medical disorders (including bleeding disorders).
- Use of systemic steroids within 2 weeks of the study, prescription medications, live viral vaccines or any recreational drug use.
- Hypersensitivity to bupivacaine, dexamethasone or any component of saline.
- Contraindication to regional anesthetic block.
- Inability to provide informed consent.
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 |
|---|---|---|
| IV dexamethasoneAlso: Dexamethasone sodium phosphate injection USPAn infusion of IV dexamethasone | Drug | Dexamethasone 2mg, Dexamethasone 4mg, Dexamethasone 8mg |
Primary outcome
The duration of sensory anesthesia and analgesia following median nerve block
Time frame: This will be assessed for up to 12 hours following block
2 secondary outcomes
The duration of motor block following median nerve block
Time frame: This will be assessed for up to 12 hours following block
Side effects related to nerve block or IV infusion of dexamethasone
Time frame: Volunteers will be phoned at 24-36 hrs and then 7-10 days to ensure full resolution of the block
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 4 Mar 2019.
- Derived from this study: PubMed 31711605Short A, El-Boghdadly K, Clarke H, Komaba T, Jin R, Chin KJ, Chan V. Effect of intravenous dexamethasone on the anaesthetic characteristics of peripheral nerve block: a double-blind, randomised controlled, dose-response volunteer study. Br J Anaesth. 2020 Jan;124(1):92-100. doi: 10.1016/j.bja.2019.08.029. Epub 2019 Nov 9.
- Individual participant dataSharing planned: Yes
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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 IV dexamethasone in people with Anesthesia, Conduction, run by University Health Network, Toronto at 1 site in Canada.
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 6 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 4 Mar 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 Canada. 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?
The duration of sensory anesthesia and analgesia following median nerve block (time frame: This will be assessed for up to 12 hours following block). 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 NCT02864602, 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 4 Mar 2019.