Oral dexamethasone as an adjunct to a peripheral nerve block in patients undergoing surgery of the forearm and hand.

Phase 1

• Conditions: Participants undergoing surgery of the bones in the hand or forearm with a lateral infraclavicular brachial plexus block as the means of providing anaesthesia and analgesia will be investigated. We will administer 12 mg dexamethasone, 24 mg dexamethasone, or placebo to increase the duration of the lateral infraclavicular plexus block..; MedDRA version: 20.0Level: LLTClassification code 10009924Term: Colles' fractureSystem Organ Class: 100000004863; MedDRA version: 20.1Level: LLTClassification code 10017297Term: Fractured metacarpalSystem Organ Class: 100000004863; MedDRA version: 20.0Level: LLTClassification code 10041223Term: Smith's fractureSystem Organ Class: 100000004863; MedDRA version: 20.1Level: LLTClassification code 10017319Term: Fractured wristSystem Organ Class: 100000004863; MedDRA version: 20.1Level: LLTClassification code 10009571Term: Closed fracture of other bone of wristSystem Organ Class: 100000004863; MedDRA version: 20.1Level: LLTClassification code 10030598Term: Open fracture of other bone of wristSystem Organ Class: 100000004863; MedDRA version: 21.1Level: LLTClassification code 10030586Term: Open fracture of metacarpal bone(s), site unspecifiedSystem Organ Class: 100000004863; MedDRA version: 21.1Level: LLTClassification code 10030531Term: Open fracture of base of other metacarpal bone(s)System Organ Class: 100000004863; MedDRA version: 21.1Level: LLTClassification code 10030594Term: Open fracture of neck of metacarpal bone(s)System Organ Class: 100000004863

• Registration Number: EUCTR2021-000428-36-DK
• Lead Sponsor: Zealand University Hospital, Department of Anaesthesiology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-16
• Last Update Posted: 17 May 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Scheduled unilateral osseous surgery of the forearm or hand.
Anaesthesia with a lateral infraclavicular brachial plexus block.
Age of 18 or above.
American Society of Anaesthesiologists Physical Status Score of 1 to 3.
For fertile women, negative urine humane choriongonadotropine test or use of safe anti-conception.
Ability to understand the trial protocol, risks and benefits, and provide signed informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

Participation in another trial involving medication.
Allergy to study medication.
Daily use of opioids above 30 mg/day morphine or equivalents.
Daily use of corticosterioids of more than 5 mg prednisolone equivalents within the past one month.
Neurological or musculoskeletal disease making block performance impossible.
Dysregulated diabetes (as judged by the investigator).
Dysregulated anticoagulants (as judged by the investigator).
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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the beneficial and harmful effects of oral dexamethasone as an adjunct to a lateral infraclavicular block in patients undergoing surgery of the bones of the forearm or hand.;Secondary Objective: Not applicable;Primary end point(s): Times to first pain (in minutes).;Timepoint(s) of evaluation of this end point: Patient-reported. Daily evaluation. Maximal follow-up 48 hours.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Duration of the motor block (in minutes, defined as the time to first ability to contracting the biceps muscle on the operative side).<br>Quality of sleep (measured on the Numerical Rating Scale from 0 to 10 points).<br>Number of patients with one or more adverse events.<br>Number of patients with one or more serious adverse events (according to the ICH-GCP).<br>Cumulative oxycodone consumption.<br>Pain (measured on the Numerical Rating Scale from 0 to 10 points.;Timepoint(s) of evaluation of this end point: Evaluated by the participant continuously. An investigator will contact the participant daily to collect outcome measures and ensure adherence to noting outcome measures. Pain will be evaluated after 24 hours and after 48 hours. The participants maximum pain and average pain on the first and second post-operative day will also be noted. Maximal follow-up 48 hours.