Does Perineural Dexamethasone Increase the Duration of an Ulnar Nerve Block When Controlling for Systemic Effects?

NCT04817982 | Completed Phase 2 DMC

• 1 other identifier: REG-138-2020
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators will assess if perineural dexamethasone can increase the duration of an ulnar nerve block when controlling for systemic effects in healthy volunteers.

Conditions

Anesthesia, Local

Keywords

Regional anesthesia; Dexamethasone; Peripheral nerve block

Outcome Measures

Primary Outcomes (1)

• Duration of the sensory nerve block, assessed by temperature discrimination (cold swab)

  The investigators will stimulate the skin with an alcohol swab and ask the participant if it is cold or warm. The duration of the sensory block will be defined as the time to the alcohol swab feels cold again. The investigators will assess temperature discrimination every 30 minutes.

  24 hours

Secondary Outcomes (4)

• Duration of the sensory nerve block, assessed by mechanical discrimination (pinprick)

  24 hours

• Duration of analgesia, assessed by pain during tonic heat stimulation (heated thermode)

  24 hours

• Duration of the motor block, assessed by fifth finger abduction

  24 hours

• Onset of the sensory nerve block, assessed by temperature discrimination (cold swab)

  24 hours

Study Arms (4)

Perineural dexamethasone

EXPERIMENTAL

Bilateral ulnar nerve blocks with bupivacaine. Dexamethasone will be added perineurally in this arm on the same day as the 'systemic dexamethasone' group.

Drug: Perineural dexamethasone

Systemic dexamethasone

ACTIVE COMPARATOR

Bilateral ulnar nerve blocks with bupivacaine. Placebo (saline) will be added perineurally in this arm on the same day as the 'perineural dexamethasone' group. Thereby, this ulnar nerve block will only be affected by the perineurally added dexamethasone that is absorbed and redistributed systemically.

Drug: Systemic dexamethasone

Placebo

PLACEBO COMPARATOR

Bilateral ulnar nerve blocks with bupivacaine. Placebo (saline) will be added perineurally in this arm on the same day as lidocaine group. This will be the actual placebo group.

Drug: Placebo

Perineural lidocaine

ACTIVE COMPARATOR

Bilateral ulnar nerve blocks with bupivacaine. Lidocaine will be added perineurally in this arm on the same day as the actual placebo group.

Drug: Lidocaine

Interventions

Perineural dexamethasone DRUG

Dexamethasone 4mg will be added perineurally to an ulnar nerve block with bupivacaine.

Perineural dexamethasone

Lidocaine DRUG

Lidocaine 40 mg will be added perineurally to an ulnar nerve block with bupivacaine.

Perineural lidocaine

Placebo DRUG

Saline will be added perineurally to an ulnar nerve block with bupivacaine.

Also known as: Saline

Placebo

Systemic dexamethasone DRUG

Dexamethasone will be added perineurally to an ulnar nerve block with bupivacaine, some will be reabsorbed and distributed systemically. Thereby, the investigators control for the systemic effects of adding perineural dexamethasone to an ulnar nerve block.

Systemic dexamethasone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18 years or above
• Must fully understand the protocol and sign written informed consent
• American Society of Anaesthesiologists Physical Status Classification System of 1 or 2
• Body Mass Index above 18 kg/m\^2
• For fertile women, safe contraceptives for the last month and negative urine human chorionic gonadotropin is required

You may not qualify if:

• Participants unable to cooperate
• Participants unable to speak or read Danish
• Age above 65 years
• Cardiovascular disease
• Allergy to study medication
• History of alcohol or substance abuse
• Intake of corticosteroids within the last 14 days
• Daily intake of prescription analgesia within the last 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

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Zealand University Hospital

Køge, Zealand Region of Denmark, 4600, Denmark

Location

MeSH Terms

Interventions

Lidocaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Mathias Maagaard, MD

  Zealand University Hospital, Køge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The trial medication will be identical in appearance and will be prepared in syringes of identical appearance with an identical volume of trial medication by an un-masked nurse who is not otherwise involved in the trial. The participant, anaesthesiologist performing the blocks, the investigators, and the outcome assessors for all outcomes will be masked to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, blinded, placebo-controlled, paired, non-inferiority trial in healthy volunteers.

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 26, 2021
• Study Start: April 7, 2021
• Primary Completion: May 15, 2021
• Study Completion: May 15, 2021
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After completion of the trial.
• Access Criteria: Research project related to this trial.

Locations

DK (1)