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

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.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000428-36-DK

Enrollment

180

Registered

2021-04-16

Start date

2021-04-21

Completion date

Unknown

Last updated

2021-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 20.0 Level: LLT Classification code 10009924 Term: Colles' fracture System Organ Class: 100000004863 MedDRA version: 20.1 Level: LLT Classificat

Interventions

Trade Name: Dexamethasone Pharmaceutical Form: Capsule INN or Proposed INN: DEXAMETHASONE Other descriptive name: Dexamethasone Concentration unit: mg milligram(s) Concentration type: range Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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). Quality of sleep (measured on the Numerical Rating Scale from 0 to 10 points). Number of patients with one or more adverse events. Number of patients with one or more serious adverse events (according to the ICH-GCP). Cumulative oxycodone consumption. 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.	—

Measure

Time frame

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). Quality of sleep (measured on the Numerical Rating Scale from 0 to 10 points). Number of patients with one or more adverse events. Number of patients with one or more serious adverse events (according to the ICH-GCP). Cumulative oxycodone consumption. 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.

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Countries

Denmark

Contacts

Public ContactDepartment of Anaesthesiology

Centre for Anaesthesiological Research, Department of Anaesthesiology, Zealand University Hospital

mmaag@regionsjaelland.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026