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Investigators will assess if perineural dexamethasone can increase the duration of an ulnar nerve block when controlling for systemic effects in healthy volunteers.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perineural dexamethasone | Drug | Dexamethasone 4mg will be added perineurally to an ulnar nerve block with bupivacaine. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mathias Maagaard, MD | Zealand University Hospital, Køge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zealand University Hospital | Køge | Zealand Region of Denmark | 4600 | Denmark |
Individual Patient Data will be shared upon reasonable request from researchers.
After completion of the trial.
Research project related to this trial.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 4, 2023 | |
| Reset | Jan 11, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 4, 2023 | Jan 11, 2024 |
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Randomised, blinded, placebo-controlled, paired, non-inferiority trial in healthy volunteers.
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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.
| 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. |
|
|
| 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. |
|
| 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 |
| Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |