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

Phase 1

• 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: 20.0Level: LLTClassification code 10002322Term: Anesthesia application siteSystem Organ Class: 100000004867; MedDRA version: 20.0Level: LLTClassification code 10002324Term: Anesthesia injection siteSystem Organ Class: 100000004867; MedDRA version: 21.0Level: LLTClassification code 10002325Term: Anesthesia localSystem Organ Class: 100000004865; MedDRA version: 21.0Level: LLTClassification code 10021946Term: Infiltration anesthesiaSystem Organ Class: 100000004865; MedDRA version: 20.1Level: LLTClassification code 10022047Term: Injection site anesthesiaSystem Organ Class: 100000004867; MedDRA version: 21.1Level: LLTClassification code 10002321Term: AnesthesiaSystem Organ Class: 100000004852; MedDRA version: 20.0Level: LLTClassification code 10038286Term: Regional nerve blockSystem Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2020-004242-10-DK
• Lead Sponsor: Centre for Anaesthesiological Research, Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-03
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): Duration of the sensory nerve block assessed by mechanical discrimination (pin-prick).<br>Duration of analgesia assessed by pain during tonic heat stimulation (heated thermode).<br>Duration of the motor block assessed by 5th finger abduction (modified Bromage scale).<br>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.