Anesthesia, LocalPhase 4ADJUNCT1NCT04853446
Oral Dexamethasone as an Adjunct to a Brachial Plexus Block in Patients Undergoing Orthopaedic Surgery of the Forearm and Hand
A Phase 4 study testing Dexamethasone 12 mg and Dexamethasone 24 mg in people with Anesthesia, Local, run by Zealand University Hospital at 3 sites in Denmark.
Trial summary
The investigators will assess the beneficial and harmful effects of oral dexamethasone (12 mg or 24 mg) versus placebo in patients undergoing orthopaedic surgery of their hand or forearm with a lateral infraclavicular brachial plexus block as the means of providing anaesthesia and analgesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Dexamethasone 12 mg and Dexamethasone 24 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 3 sitesDenmark
- Study dates
- 28 Jun 2021to 4 May 2023
- Phase
- Phase 4
- 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
- Scheduled for unilateral osseous surgery of the hand or forearm.
- Anaesthesia with an infraclavicular brachial plexus block
- Age of 18 or above
- American Society of Anaesthesiologists Physical Status Score of 1 to 3
- Body Mass Index of 18 to 40, but a minimum weight of 50 kg.
- For fertile women, negative urine humane choriongonadotropine test and use of safe anti-conception
- Ability to understand the trial protocol, risks and benefits, and provide signed informed consent
Who cannot join
- Inability to read and understand Danish
- Uncooperativeness (as judged by investigators)
- Participation in another trial involving medication
- Allergy to study medication
- Daily use of opioids above 30 mg/day morphine (or equivalents)
- Daily use of corticosteroids of more than 5 mg prednisolone equivalents within the past one month
Show all 14Show fewer
- Neurological or musculoskeletal disease making block performance impossible (as judged by investigators)
- Dysregulated diabetes (as judged by investigators)
- Dysregulated anti-coagulants (as judged by investigators)
- History of drug or alcohol abuse
- Glaucoma
- Contraindications for paracetamol or opioids
- Other concomitant conditions needing surgery
- Other concomitant traumatic injuries
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Department of Anaesthesiology, Bispebjerg Hospital
Copenhagen, 2400
Department of Anaesthesiology
Køge, Zealand Region of Denmark, 4600
Department of Anaesthesiology
Slagelse, Zealand Region of Denmark, 4200
About this study
Official title: Oral Dexamethasone as an Adjunct to a Brachial Plexus Block in Patients Undergoing Orthopaedic Surgery of the Forearm and Hand. A Randomised, Blinded, Placebo-controlled, Parallel, Triple-arm Clinical Trial.
The investigators will assess the beneficial and harmful effects of oral dexamethasone (12 mg or 24 mg) versus placebo in patients undergoing orthopaedic surgery of their hand or forearm with a lateral infraclavicular brachial plexus block as the means of providing anaesthesia and analgesia.
Read the detailed description
This is a randomised, blinded, placebo-controlled, multicentre, parallel, 3-arm clinical trial assessing the effects of adjunct oral dexamethasone (12mg or 24mg) versus placebo on time to first pain (i.e. block duration) in patients undergoing surgery of the forearm or hand. At the initiation of the trial, no other trials had examined the effects of oral dexamethasone as an adjunct to peripheral nerve blocks.
The investigators will randomise participants to either oral dexamethasone 12mg, oral dexamethasone 24mg, or placebo. Participants will be allocated according to a computer-generated random allocation sequence with random permuted blocks and stratification by site. Glostrup Pharmacy produced the trial medication and sequentially numbered the drug containers, thereby concealing the allocation.
All involved will be blinded for the entire duration of the trial (participant, carers, investigators, people delivering the intervention, observers/outcome assessors, statisticians). Blinding will not be broken until agreement has been reached within the steering committee regarding the statistical analysis. The trial medication is produced as identically appearing opaque capsules containing either dexamethasone or placebo. The trial medication is contained within identically appearing, sequentially labelled containers.
The investigators expect little to no attrition bias since the intervention is simple with a short follow-up. The investigators expect some missing data for duration of the motor block, as most participants will have the affected limb immobilized post-surgery, thereby making assessment of return of motor function difficult.
The investigators pre-defined the statistical analysis plan prior to unblinded data becoming available. The analysis plan can be found on: https://doi.org/10.6084/m9.figshare.22491214.
- Conditions
- Anesthesia, Local
- Being tested
- Dexamethasone 12 mg, Placebo, Dexamethasone 24 mg
- Keywords
- Peripheral nerve block, Dexamethasone, Adjunct, Regional anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 12 mgDrug
Two identically appearing, opaque capsules will be administered: one capsule containing 12 mg of dexamethasone and one capsule containing placebo.
PlaceboDrug
Two identically appearing, opaque capsules will be administered: two capsules containing placebo.
Dexamethasone 24 mgDrug
Two identically appearing, opaque capsules will be administered: two capsules each containing 12mg dexamethasone.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Encapsulated glucosemonohydrate will be used as placebo. Two capsules containing placebo will be administered in the placebo arm. Receives: Drug: Placebo |
| Dexamethasone 12 mg | Experimental | Dexamethasone tablets of 4 mg encapsulated in pairs of three. One capsule containing 12 mg dexamethasone and one capsule containing placebo will be administered in the 12mg dexamethasone arm for a total dose of 12 mg of dexamethasone. Receives: Drug: Dexamethasone 12 mg |
| Dexamethasone 24 mg | Experimental | Dexamethasone tablets of 4 mg encapsulated in pairs of three. Two capsules containing 12 mg dexamethasone will be administered in the 25mg dexamethasone arm for a total dose of 24 mg of dexamethasone. Receives: Drug: Dexamethasone 24 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first pain (measured in minutes)
Time to first pain will be recorded by the patient and measured as the time to first perceived pain in minutes in the surgical area. The patient will be asked to record the time and date of their first perceived pain in their trial log. This date and time will be compared to the date and time of the block performance as recorded in the electronic Case Report Form. In the event of the patient not experiencing any pain, the time to first pain will be set to 48 hours.
Measured: 48 hours
Secondary outcomes (5)
Duration of the motor block (measured in minutes)
Duration of the motor block will be recorded by the patient and measured in minutes as the time from removal of the needle to the first movement of their bicep muscle on the operative site, and not the first movement of their distal extremity. The patient will record the date and time of their time to first bicep movement on the operative side in their trial log. This date and time will be compared to the date and time of the block performance as registered in the electronic Case Report Form. In the event of the patient not regaining movement of the bicep, the duration of the motor block will be set to 48 hours.
Measured: 48 hours
Quality of sleep (Numerical Rating Scale) postoperative night 1
Sleep will be measured on the Numerical Rating Scale from '0' to '10' points where '0' points correspond to the worst possible sleep and '10' points correspond to the best possible sleep. This outcome measure will be recorded by the patients in their trial log after the first postoperative night.
Measured: 24 hours
Quality of sleep (Numerical Rating Scale) postoperative night 2
Sleep will be measured on the Numerical Rating Scale from '0' to '10' points where '0' points correspond to the worst possible sleep and '10' points correspond to the best possible sleep. This outcome measure will be recorded by the patients in their trial log after the second postoperative night.
Measured: 48 hours
Proportion of participants with one or more serious adverse events.
Serious adverse events as defined by the ICH-GCP will be collected and reported as the proportion of participants with one or more serious adverse events. Furthermore, the individual serious adverse events will also be reported.
Measured: 30 days
Proportion of participants with one or more adverse events not considered to be serious
We will record any adverse events not considered to be serious. We will report the proportion of participants with one or more adverse events not considered to be serious and all individual adverse events not considered to be serious.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start28 Jun 2021
- Primary completion4 Apr 2023
- Study completion4 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathias Maagaard, MD, Principal investigator, Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853446
- Sponsor's protocol ID
- ADJUNCT1
- Acronym
- ADJUNCT1
- Status last verified
- May 2023
- First submitted
- 19 Apr 2021
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient data in anonymised form will be shared upon reasonable request to the primary investigator.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Dexamethasone as an Adjunct to a Brachial Plexus Block in Patients Undergoing Orthopaedic Surgery of the Forearm and Hand. A Randomised, Blinded, Placebo-controlled, Parallel, Triple-arm Clinical Trial.
- ClinicalTrials.gov ID
- NCT04853446
- Acronym / sponsor ID
- ADJUNCT1 / ADJUNCT1
- Conditions
- Anesthesia, Local
- Keywords
- Peripheral nerve block, Dexamethasone, Adjunct, Regional anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 21 Apr 2021 (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.
The investigators will assess the beneficial and harmful effects of oral dexamethasone (12 mg or 24 mg) versus placebo in patients undergoing orthopaedic surgery of their hand or forearm with a lateral infraclavicular brachial plexus block as the means of providing anaesthesia and analgesia.
Detailed description
This is a randomised, blinded, placebo-controlled, multicentre, parallel, 3-arm clinical trial assessing the effects of adjunct oral dexamethasone (12mg or 24mg) versus placebo on time to first pain (i.e. block duration) in patients undergoing surgery of the forearm or hand. At the initiation of the trial, no other trials had examined the effects of oral dexamethasone as an adjunct to peripheral nerve blocks.
The investigators will randomise participants to either oral dexamethasone 12mg, oral dexamethasone 24mg, or placebo. Participants will be allocated according to a computer-generated random allocation sequence with random permuted blocks and stratification by site. Glostrup Pharmacy produced the trial medication and sequentially numbered the drug containers, thereby concealing the allocation.
All involved will be blinded for the entire duration of the trial (participant, carers, investigators, people delivering the intervention, observers/outcome assessors, statisticians). Blinding will not be broken until agreement has been reached within the steering committee regarding the statistical analysis. The trial medication is produced as identically appearing opaque capsules containing either dexamethasone or placebo. The trial medication is contained within identically appearing, sequentially labelled containers.
The investigators expect little to no attrition bias since the intervention is simple with a short follow-up. The investigators expect some missing data for duration of the motor block, as most participants will have the affected limb immobilized post-surgery, thereby making assessment of return of motor function difficult.
The investigators pre-defined the statistical analysis plan prior to unblinded data becoming available. The analysis plan can be found on: https://doi.org/10.6084/m9.figshare.22491214.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboEncapsulated glucosemonohydrate will be used as placebo. Two capsules containing placebo will be administered in the placebo arm. |
| Dexamethasone 12 mg | Experimental | Drug: Dexamethasone 12 mgDexamethasone tablets of 4 mg encapsulated in pairs of three. One capsule containing 12 mg dexamethasone and one capsule containing placebo will be administered in the 12mg dexamethasone arm for a total dose of 12 mg of dexamethasone. |
| Dexamethasone 24 mg | Experimental | Drug: Dexamethasone 24 mgDexamethasone tablets of 4 mg encapsulated in pairs of three. Two capsules containing 12 mg dexamethasone will be administered in the 25mg dexamethasone arm for a total dose of 24 mg of dexamethasone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Scheduled for unilateral osseous surgery of the hand or forearm.
- Anaesthesia with an infraclavicular brachial plexus block
- Age of 18 or above
- American Society of Anaesthesiologists Physical Status Score of 1 to 3
- Body Mass Index of 18 to 40, but a minimum weight of 50 kg.
Key exclusion criteria (14 listed)
- Inability to read and understand Danish
- Uncooperativeness (as judged by investigators)
- Participation in another trial involving medication
- Allergy to study medication
- Daily use of opioids above 30 mg/day morphine (or equivalents)
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 12 mgTwo identically appearing, opaque capsules will be administered: one capsule containing 12 mg of dexamethasone and one capsule containing placebo. | Drug | Dexamethasone 12 mg |
| PlaceboTwo identically appearing, opaque capsules will be administered: two capsules containing placebo. | Drug | Placebo |
| Dexamethasone 24 mgTwo identically appearing, opaque capsules will be administered: two capsules each containing 12mg dexamethasone. | Drug | Dexamethasone 24 mg |
Primary outcome
Time to first pain (measured in minutes)
Time frame: 48 hours
Time to first pain will be recorded by the patient and measured as the time to first perceived pain in minutes in the surgical area. The patient will be asked to record the time and date of their first perceived pain in their trial log. This date and time will be compared to the date and time of the block performance as recorded in the electronic Case Report Form. In the event of the patient not experiencing any pain, the time to first pain will be set to 48 hours.
5 secondary outcomes
Duration of the motor block (measured in minutes)
Time frame: 48 hours
Quality of sleep (Numerical Rating Scale) postoperative night 1
Time frame: 24 hours
Quality of sleep (Numerical Rating Scale) postoperative night 2
Time frame: 48 hours
Proportion of participants with one or more serious adverse events.
Time frame: 30 days
Proportion of participants with one or more adverse events not considered to be serious
Time frame: 48 hours
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 25 May 2023.
- Individual participant dataSharing planned: Yes. Individual patient data in anonymised form will be shared upon reasonable request to the primary investigator.
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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.
Mathias Maagaard, MD principal investigator
Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone 12 mg and Dexamethasone 24 mg in people with Anesthesia, Local, run by Zealand University Hospital at 3 sites in Denmark.
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 7 inclusion and 14 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 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 first pain (measured in minutes) (time frame: 48 hours). 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 25 May 2023.