Oral Dexamethasone as an Adjunct to a Brachial Plexus Block in Patients Undergoing Orthopaedic Surgery of the Forearm and Hand
- Conditions
- Anesthesia, Local
- Interventions
- Registration Number
- NCT04853446
- Lead Sponsor
- Zealand University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dexamethasone 24 mg Dexamethasone 24 mg 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. Dexamethasone 12 mg Dexamethasone 12 mg 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. Placebo Placebo Encapsulated glucosemonohydrate will be used as placebo. Two capsules containing placebo will be administered in the placebo arm.
- Primary Outcome Measures
Name Time Method Time to first pain (measured in minutes) 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.
- Secondary Outcome Measures
Name Time Method Duration of the motor block (measured in minutes) 48 hours 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.
Quality of sleep (Numerical Rating Scale) postoperative night 2 48 hours 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.
Proportion of participants with one or more serious adverse events. 30 days 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.
Quality of sleep (Numerical Rating Scale) postoperative night 1 24 hours 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.
Proportion of participants with one or more adverse events not considered to be serious 48 hours 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.
Trial Locations
- Locations (2)
Department of Anaesthesiology
🇩🇰Slagelse, Zealand Region Of Denmark, Denmark
Department of Anaesthesiology, Bispebjerg Hospital
🇩🇰Copenhagen, Denmark