E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Participants undergoing surgery of the bones in the hand or forearm with a lateral infraclavicular brachial plexus block as the means of providing anaesthesia and analgesia will be investigated. We will administer 12 mg dexamethasone, 24 mg dexamethasone, or placebo to increase the duration of the lateral infraclavicular plexus block.. |
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E.1.1.1 | Medical condition in easily understood language |
Patients undergoing surgery of the bones in the hand or forearm with a nerve block in their shoulder region will be investigated. |
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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 | 10009924 |
E.1.2 | Term | Colles' fracture |
E.1.2 | System Organ Class | 100000004863 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 24.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10017297 |
E.1.2 | Term | Fractured metacarpal |
E.1.2 | System Organ Class | 100000004863 |
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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 | 10041223 |
E.1.2 | Term | Smith's fracture |
E.1.2 | System Organ Class | 100000004863 |
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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 | 10017319 |
E.1.2 | Term | Fractured wrist |
E.1.2 | System Organ Class | 100000004863 |
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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 | 10009571 |
E.1.2 | Term | Closed fracture of other bone of wrist |
E.1.2 | System Organ Class | 100000004863 |
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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 | 10030598 |
E.1.2 | Term | Open fracture of other bone of wrist |
E.1.2 | System Organ Class | 100000004863 |
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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 | 10030586 |
E.1.2 | Term | Open fracture of metacarpal bone(s), site unspecified |
E.1.2 | System Organ Class | 100000004863 |
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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 | 10030531 |
E.1.2 | Term | Open fracture of base of other metacarpal bone(s) |
E.1.2 | System Organ Class | 100000004863 |
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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 | 10030594 |
E.1.2 | Term | Open fracture of neck of metacarpal bone(s) |
E.1.2 | System Organ Class | 100000004863 |
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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 | 10017154 |
E.1.2 | Term | Fracture of metacarpal bone(s) |
E.1.2 | System Organ Class | 100000004863 |
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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 | 10030587 |
E.1.2 | Term | Open fracture of metacarpal bones |
E.1.2 | System Organ Class | 100000004863 |
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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 | 24.0 |
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.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the beneficial and harmful effects of oral dexamethasone as an adjunct to a lateral infraclavicular block in patients undergoing surgery of the bones of the forearm or hand. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Scheduled unilateral osseous surgery of the forearm or hand. Anaesthesia with a lateral infraclavicular brachial plexus block. Age of 18 or above. American Society of Anaesthesiologists Physical Status Score of 1 to 3. For fertile women, negative urine humane choriongonadotropine test or use of safe anti-conception. Ability to understand the trial protocol, risks and benefits, and provide signed informed consent. |
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E.4 | Principal exclusion criteria |
Participation in another trial involving medication. Allergy to study medication. Daily use of opioids above 30 mg/day morphine or equivalents. Daily use of corticosterioids of more than 5 mg prednisolone equivalents within the past one month. Neurological or musculoskeletal disease making block performance impossible. Dysregulated diabetes (as judged by the investigator). Dysregulated anticoagulants (as judged by the investigator). History of drug or alcohol abuse. Glaucoma. Contraindications for paracetamol or opioids. Other concomitant conditions needing surgery. Other concomitant traumatic injuries. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Times to first pain (in minutes). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Patient-reported. Daily evaluation. Maximal follow-up 48 hours. |
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E.5.2 | Secondary end point(s) |
Duration of the motor block (in minutes, defined as the time to first ability to contracting the biceps muscle on the operative side). Quality of sleep (measured on the Numerical Rating Scale from 0 to 10 points). Number of patients with one or more adverse events. Number of patients with one or more serious adverse events (according to the ICH-GCP). Cumulative oxycodone consumption. Pain (measured on the Numerical Rating Scale from 0 to 10 points. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Evaluated by the participant continuously. An investigator will contact the participant daily to collect outcome measures and ensure adherence to noting outcome measures. Pain will be evaluated after 24 hours and after 48 hours. The participants maximum pain and average pain on the first and second post-operative day will also be noted. Maximal follow-up 48 hours. |
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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 | No |
E.6.4 | Safety | Yes |
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 | Yes |
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 | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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 finished when the last patient has been followed-up, data has been analysed, and blinding broken. |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |