E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
postoperative pain |
postoepratieve pijn |
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E.1.1.1 | Medical condition in easily understood language |
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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.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
What is the effect of different doses of perineural dexamethasone on postoperative analgesia after interscalene plexus block for shoulder surgery. |
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E.2.2 | Secondary objectives of the trial |
What is the effect of different doses of dexamethasone on postoperative painscores, analgesic use, patient satisfaction, duration and quality of motor block and sleep disturbance. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All patients presenting for elective arthroscopic shoulder surgery (incl. decompression and cuff repairs), aged 18-85 years willing to sign informed consent. |
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E.4 | Principal exclusion criteria |
• Contraindications for brachial plexus blocks: coagulopathies, severe bronchopulmonary disease, intolerance to the study medication, pre-existing neuropathies, infection in the region of the interscalene groove. • Weight <50kg • Systemic glucocorticoid use • Pregnancy • Diabetes • Chronic use of opioids • History of addiction • Oncologic history with chemotherapy (Taxol, Vincristine etc.) • Known polyneuropathy • Surgery or radiation therapy of the neck • BMI >30 • Impossibility to understand and sign the informed consent • Refusal of the patient
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to first analgesic request |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• Onset of sensory block: time from injection to complete sensory block • Onset of motor block: time from injection to complete motor block • Duration of motor block: time from injection to start of recovery of the motor block • Postoperative analgesic drug consumption • Pain scores at different endpoints (PACU admission, PACU discharge, Hospital discharge, 24 hours, 48 hours post block) expressed on a numeric rating scale (NRS 0-10, 0= no pain, 10= worst pain imaginable) • Incidence of postoperative nausea and vomiting • Incidence of pruritus • Patient satisfaction score expressed in a numeric rating scale (NRS 0-10, 0= totally dissatisfied, 10= complete satisfaction) • Incidence of hematoma formation at 48 hours • Incidence of infections at 48 hours and after 7 days • Incidence of neuropathic pain at 7 days and at 3 months postoperatively • Incidence of paresthesias at 7 days and at 3 months postoperatively • Incidence of muscle weakness at 7 days and at 3 months postoperatively
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | 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 | 5 |
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 | Yes |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |