ADJUNCT1: Oral Dexamethasone as an Adjunct to a Brachial Plexus Block in Patients Undergoing Orthopaedic Surgery of the Forearm and Hand
Study Details
Study Description
Brief Summary
We will assess the beneficial and harmful effects of oral dexamethason (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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Capsulated glucosemonohydrate will be used as placebo. Two capsules of placebo will be adminstered. |
Drug: Placebo
Two capsules of placebo (glucosemonohydrate) will be administered.
|
| Experimental: Dexamethasone 12 mg Dexamethasone tablets of 4 mg encapsulated in pairs of three. One capsule of 12 mg dexamethasone and one capsule of placebo for a total dose of 12 mg of dexamethasone will be administered. |
Drug: Dexamethasone 12 mg
One capsule of 12 mg of dexamethasone will be administered and one capsule of placebo.
|
| Experimental: Dexamethasone 24 mg Dexamethasone tablets of 4 mg encapsulated in pairs of three. Two capsules of 12 mg dexamethasone for a total for 24 mg of dexamethasone will be administered. |
Drug: Dexamethasone 24 mg
Two capsules of 12 mg of dexamethasone will be administered.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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) [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. The outcome measure will be recorded by the patients in their trial log after the first postoperative night and 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.
- 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.
Other Outcome Measures
- Cumulative oxycodone consumption (measured in milligrams) [48 hours]
Cumulative oxycodone consumption will be recorded in the electronic medical files of the patients during hospitalisation and in their trial log at 24 hours and 48 hours by the patient after discharge. The patient will be instructed to record whenever they ingest escape oxycodone, as well as record the total amount of ingested escape oxycodone at 48 hours postoperatively. The patient will be instructed to not count in any usual opioid consumption, but only the escape oxycodone provided by the investigators.
- Pain (measured on the Numerical Rating Scale) [48 hours]
Pain will be recorded during rest and measured on the Numerical Rating Scale from '0' to '10' points where '0' points correspond to no pain and '10' points correspond to the worst possible pain. The patients will record their perceived pain at 24 hours and 48 hours in their trial log. The patient will also be asked to record their highest pain and average pain between 0 hours and 24 hours, and 24 hours and 48 hours postoperatively
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Anaesthesiology | Køge | Zealand Region Of Denmark | Denmark | 4600 |
| 2 | Department of Anaesthesiology | Slagelse | Zealand Region Of Denmark | Denmark | 4200 |
Sponsors and Collaborators
- Zealand University Hospital
Investigators
- Principal Investigator: Mathias Maagaard, MD, Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ADJUNCT1