E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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E.1.1.1 | Medical condition in easily understood language |
We will not assess a specific medical condition or disease. We will assess if dexamethasone increases the duration of a peripheral nerve block when applied locally (i.e. directly to the nerve). |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002322 |
E.1.2 | Term | Anesthesia application site |
E.1.2 | System Organ Class | 100000004867 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002324 |
E.1.2 | Term | Anesthesia injection site |
E.1.2 | System Organ Class | 100000004867 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002325 |
E.1.2 | Term | Anesthesia local |
E.1.2 | System Organ Class | 100000004865 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021946 |
E.1.2 | Term | Infiltration anesthesia |
E.1.2 | System Organ Class | 100000004865 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022047 |
E.1.2 | Term | Injection site anesthesia |
E.1.2 | System Organ Class | 100000004867 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002321 |
E.1.2 | Term | Anesthesia |
E.1.2 | System Organ Class | 100000004852 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038286 |
E.1.2 | Term | Regional nerve block |
E.1.2 | System Organ Class | 100000004865 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Duration of the sensory nerve block assessed by temperature discrimination (alcohol cold swab) |
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E.5.1.1 | 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. |
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E.5.2 | Secondary end point(s) |
Duration of the sensory nerve block assessed by mechanical discrimination (pin-prick). Duration of analgesia assessed by pain during tonic heat stimulation (heated thermode). Duration of the motor block assessed by 5th finger abduction (modified Bromage scale). Onset of the sensory nerve block assessed by temperature discrimination (alcohol cold swab). |
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E.5.2.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial will be considered complete when all participants, except for those withdrawing from participation, has completed both trial days. Each trial day will be considered complete when the ulnar nerve block has worn off or 48 hours after block performance despite return of normal sensation in the hypothenar area or normal strength in the 5th digit. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |