Does dexamethasone increase the duration of a peripheral nerve block when applied directly to the nerve?

Does perineural dexamethasone increase the duration of an ulnar nerve block when controlling for systemic effects? A randomised, blinded, placebo-controlled, paired, non-inferiority trial in healthy volunteers

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004242-10-DK

Enrollment

Registered

2020-11-03

Start date

2020-12-21

Completion date

Unknown

Last updated

2021-11-29

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

Conditions

We will not assess a specific medical condition or disease as only healthy volunteers are included. We will assess if perineural dexamethasone increases the duration of a peripheral nerve block (i.e. as used in orthopaedic surgery) when controlling for systemic effects. MedDRA version: 20.0 Level: LLT Classification code 10002322 Term: Anesthesia application site System Organ Class: 100000004867 MedDRA version: 20.0 Level: LLT Classification code 10002324 Term: Anesthesia injection site System

Interventions

Trade Name: Dexamethasone Pharmaceutical Form: Solution for injection INN or Proposed INN: DEXAMETHASONE Other descriptive name: Dexamethasone Concentration unit: mg/ml milligram(s)/millilitre Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy men or women, 18 years or older, must fully understand protocol and be capable of signing informed written consent, American Society of Anaesthesiologists Physical Status Classification System (ASA) of 1 or 2. Body Mass Index of 18 or above, for fertile women either safe contraceptives for the past month or a negative urine human chorionic gonadotropine test. 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 16 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Unable to cooperate, unable to speak or read Danish, allergy to study medication, history of alcohol or substance abuse, intake of corticosteroids within the past 14 days, daily intake of prescription analgesia within the past four weeks, intake of over the counter analgesia within the last 48 hours, neuromuscular diseases or wounds on the arms or hands preventing adequate test or block performance, diabetes mellitus.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate if perineural dexamethasone increases the duration of an ulnar nerve block when controlling for the systemic effects of dexamethasone. We will primarily assess the duration of the ulnar nerve block by temperature discrimination.;Secondary Objective: We will assess the duration of the nerve block by mechanical discrimination, pain sensation, and motor block. We will also assess the time to onset of the block by temperature discrimination and motor block.;Primary end point(s): Duration of the sensory nerve block assessed by temperature discrimination (alcohol cold swab);Timepoint(s) of evaluation of this end point: Every 30 minutes until the peripheral nerve block has worn off. The block will be considered to have worn off when an alcohol swab feels cold again and Bromage reaches '4' or the participant indicates a feeling of normal strength in the 5th digit.	—

Measure

Time frame

Main Objective: To investigate if perineural dexamethasone increases the duration of an ulnar nerve block when controlling for the systemic effects of dexamethasone. We will primarily assess the duration of the ulnar nerve block by temperature discrimination.;Secondary Objective: We will assess the duration of the nerve block by mechanical discrimination, pain sensation, and motor block. We will also assess the time to onset of the block by temperature discrimination and motor block.;Primary end point(s): Duration of the sensory nerve block assessed by temperature discrimination (alcohol cold swab);Timepoint(s) of evaluation of this end point: Every 30 minutes until the peripheral nerve block has worn off. The block will be considered to have worn off when an alcohol swab feels cold again and Bromage reaches '4' or the participant indicates a feeling of normal strength in the 5th digit.

—

Secondary

Measure	Time frame
Secondary end point(s): Duration of the sensory nerve block assessed by mechanical discrimination (pin-prick). Duration of analgesia assessed by pain during tonic heat stimulation (heated thermode). Duration of the motor block assessed by 5th finger abduction (modified Bromage scale). Onset of the sensory nerve block assessed by temperature discrimination (alcohol cold swab).;Timepoint(s) of evaluation of this end point: Onset will be measured every 5 minutes and defined as the time from block performance until an alcohol swab no longer feels cold.	—

Measure

Time frame

Secondary end point(s): Duration of the sensory nerve block assessed by mechanical discrimination (pin-prick). Duration of analgesia assessed by pain during tonic heat stimulation (heated thermode). Duration of the motor block assessed by 5th finger abduction (modified Bromage scale). Onset of the sensory nerve block assessed by temperature discrimination (alcohol cold swab).;Timepoint(s) of evaluation of this end point: Onset will be measured every 5 minutes and defined as the time from block performance until an alcohol swab no longer feels cold.

—

Countries

Denmark

Contacts

Public ContactDepartment of Anaesthesiology

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

mmaag@regionsjaelland.dk

Outcome results

None listed

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