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

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.

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

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local
• Intervention / Treatment: Drug: Perineural dexamethasone; Drug: Systemic dexamethasone; Drug: Placebo; Drug: Lidocaine

Detailed Description

Healthy volunteers will have bilateral ulnar nerve blocks performed with bupivacaine on two different days with a minimum of 14 days wash-out. On one day, the participants will also receive dexamethasone in one arm and placebo in the other. On the other day, the participants will also receive placebo in one arm and lidocaine in the other. By this using this design, the investigators will be able to assess if perineural dexamethasone can increase the duration of an ulnar nerve block when controlling for the systemic effects. Furthermore, to ensure blinding, the investigators have also incorporated the lidocaine group which also allows for the assessment of the effects of adding lidocaine to a peripheral nerve block with bupivacaine. The order of which the participant will receive dexamethasone and lidocaine will be random. It will also be random in which arm the participant receives dexamethasone and lidocaine.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Zealand Region Of Denmark
    • Køge, Zealand Region Of Denmark, Denmark, 4600
      • Zealand University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Perineural dexamethasone; 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; Dexamethasone 4mg will be added perineurally to an ulnar nerve block with bupivacaine.
Active Comparator: Systemic dexamethasone; 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; 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.
Placebo Comparator: Placebo; 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; Saline will be added perineurally to an ulnar nerve block with bupivacaine.; Other Names: Saline
Active Comparator: Perineural lidocaine; 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; Lidocaine 40 mg will be added perineurally to an ulnar nerve block with bupivacaine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of the sensory nerve block, assessed by mechanical discrimination (pinprick)	The investigators will stimulate the skin with a needle. The duration of the sensory block will be defined as the time to the needle feels sharp again. The investigators will assess mechanical discrimination every 30 minutes.	24 hours
Duration of analgesia, assessed by pain during tonic heat stimulation (heated thermode)	The investigators will stimulate the participants' skin for 30 seconds with a thermode heated to 45 degrees Celsius. The participants rate the pain elicited on the Visual Analogue Scale using a ruler indicating "no pain" at zero millimetre on one end and "worst perceivable pain" at 100 millimetres at the opposite end. The duration of the sensory block will be defined as the time to the tonic heat stimulation elicits a painful response of Visual Analogue Scale above '0'. The investigators will assess pain every 30 minutes.	24 hours
Duration of the motor block, assessed by fifth finger abduction	The hand is placed facing with the volar side upwards. The hand is constricted so that only the fifth finger can abduct. The motor block is assessed using a Modified Bromage Scale. The duration of motor block is the time from block performance until Bromage grade '4' is reached or the participant indicates a feeling of normal strength in the finger.	24 hours
Onset 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 onset of the sensory block will be defined as the time to the alcohol swab no longer feels cold. The investigators will assess the onset by temperature discrimination every 5 minutes.	24 hours

Collaborators and Investigators

• Sponsor: Zealand University Hospital
• Investigators: Principal Investigator: Mathias Maagaard, MD, Zealand University Hospital, Køge

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2021
• Primary Completion (Actual): May 15, 2021
• Study Completion (Actual): May 15, 2021

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Actual): July 1, 2021
• Last Update Submitted That Met QC Criteria: June 28, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Dexamethasone; Regional anesthesia; Peripheral nerve block
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Dexamethasone; Dexamethasone acetate; BB 1101; Lidocaine
• Other Study ID Numbers: REG-138-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual Patient Data will be shared upon reasonable request from researchers.
• IPD Sharing Time Frame: After completion of the trial.
• IPD Sharing Access Criteria: Research project related to this trial.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No