Oral Dexamethasone as an Adjunct to a Brachial Plexus Block in Patients Undergoing Orthopaedic Surgery of the Forearm and Hand

NCT04853446 | Completed Phase 4 DMC

• 1 other identifier: ADJUNCT1
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 3

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.

Conditions

Anesthesia, Local

Keywords

Peripheral nerve block; Dexamethasone; Adjunct; Regional anesthesia

Outcome Measures

Primary Outcomes (1)

• 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.

  48 hours

Secondary Outcomes (5)

• Duration of the motor block (measured in minutes)

  48 hours

• Quality of sleep (Numerical Rating Scale) postoperative night 1

  24 hours

• Quality of sleep (Numerical Rating Scale) postoperative night 2

  48 hours

• Proportion of participants with one or more serious adverse events.

  30 days

• Proportion of participants with one or more adverse events not considered to be serious

  48 hours

Other Outcomes (9)

• Cumulative oxycodone consumption (measured in milligrams) at 24 hours

  24 hours

• Cumulative oxycodone consumption (measured in milligrams) at 48 hours

  48 hours

• Pain (measured on the Numerical Rating Scale) at 24 hours postoperatively

  24 hours

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Encapsulated glucosemonohydrate will be used as placebo. Two capsules containing placebo will be administered in the placebo arm.

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.

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.

Drug: Dexamethasone 24 mg

Interventions

Dexamethasone 12 mg DRUG

Two identically appearing, opaque capsules will be administered: one capsule containing 12 mg of dexamethasone and one capsule containing placebo.

Dexamethasone 12 mg

Placebo DRUG

Two identically appearing, opaque capsules will be administered: two capsules containing placebo.

Placebo

Dexamethasone 24 mg DRUG

Two identically appearing, opaque capsules will be administered: two capsules each containing 12mg dexamethasone.

Dexamethasone 24 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (3)

Department of Anaesthesiology

Køge, Zealand Region of Denmark, 4600, Denmark

Location

Department of Anaesthesiology

Slagelse, Zealand Region of Denmark, 4200, Denmark

Location

Department of Anaesthesiology, Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Mathias Maagaard, MD

  Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The trial medication was produced by Glostrup Pharmacy. The trial medication is produced as identically appearing opaque capsules containing either dexamethasone or placebo. The trial medication is stored in sequentially numbered containers that will be allocated to each participant as they enter the trial. All involved in the trial will be masked to treatment allocation until the final statistical analysis has been agreed upon by the steering committee.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 21, 2021
• Study Start: June 28, 2021
• Primary Completion: April 4, 2023
• Study Completion: May 4, 2023
• Last Updated: May 25, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When the trial has been completed, data analysed, and trials results published.
• Access Criteria: Individual patient data in anonymised form will be shared upon reasonable request to the primary investigator.

Locations

DK (3)