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Completed

NCT Number: NCT04817982

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

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

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Zealand University Hospital

Køge, Zealand Region of Denmark, 4600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Perineural dexamethasone

Drug

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

Lidocaine

Drug

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

Placebo

Drug

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

Other names: Saline

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.

Primary outcomes

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

    Time frame: 24 hours

    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.

Secondary outcomes

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

    Time frame: 24 hours

    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.

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

    Time frame: 24 hours

    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.

  3. Duration of the motor block, assessed by fifth finger abduction

    Time frame: 24 hours

    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.

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

    Time frame: 24 hours

    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.

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Official study title

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.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 26, 2021
Registry last updated
Jul 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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