Clinical trial NCT04853446: Oral Dexamethasone as an Adjunct to a Brachial Plexus Block in Patients Undergoing Orthopaedic Surgery of the Forearm and Hand
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia, Local
Keywords: Peripheral nerve block
Dexamethasone
Adjunct
Regional anesthesia
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Time to first pain (measured in minutes)
timeFrame: 48 hours
Secondary outcomes:
measure: Duration of the motor block (measured in minutes)
timeFrame: 48 hours
measure: Quality of sleep (Numerical Rating Scale) postoperative night 1
timeFrame: 24 hours
measure: Quality of sleep (Numerical Rating Scale) postoperative night 2
timeFrame: 48 hours
measure: Proportion of participants with one or more serious adverse events.
timeFrame: 30 days
measure: Proportion of participants with one or more adverse events not considered to be serious
timeFrame: 48 hours
Other outcomes:
measure: Cumulative oxycodone consumption (measured in milligrams) at 24 hours
timeFrame: 24 hours
measure: Cumulative oxycodone consumption (measured in milligrams) at 48 hours
timeFrame: 48 hours
measure: Pain (measured on the Numerical Rating Scale) at 24 hours postoperatively
timeFrame: 24 hours
measure: Average pain (measured on the Numerical Rating Scale) from 0 to 24 hours postoperatively
timeFrame: 24 hours
measure: Worst pain (measured on the Numerical Rating Scale) from 0 to 24 hours postoperatively
timeFrame: 24 hours
measure: Pain (measured on the Numerical Rating Scale) at 48 hours postoperatively
timeFrame: 48 hours
measure: Average pain (measured on the Numerical Rating Scale) from 24 to 48 hours postoperatively
timeFrame: 48 hours
measure: Worst pain (measured on the Numerical Rating Scale) from 24 to 48 hours postoperatively
timeFrame: 48 hours
measure: Patient satisfaction (added after initiation of the trial, will only be available for a subset of the patients)
timeFrame: 48 hours
Locations:
city: Køge
country: Denmark
facility: Department of Anaesthesiology
state: Zealand Region Of Denmark
city: Slagelse
country: Denmark
facility: Department of Anaesthesiology
state: Zealand Region Of Denmark
city: Copenhagen
country: Denmark
facility: Department of Anaesthesiology, Bispebjerg Hospital
Study officials:
affiliation: Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark
name: Mathias Maagaard, MD
role: PRINCIPAL_INVESTIGATOR
References: