E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
different volumes (10 vs 20mL) of ropvacaine 0.5 %will be investigated, when used for interscalene brachial plexus block in shoulder surgery |
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E.1.1.1 | Medical condition in easily understood language |
different volumes (10 vs 20mL) of local anesthetic (ropivacaine 0.5%) will be investigated, when used for peripheral nerve block in shoulder surgery |
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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 |
We aim to evaluate whether the use of ultrasound guidance and decreased volumes of local anesthetic (10 ml ropivacaine 0.5%) is as effective as larger volumes of local anesthetic (20 ml ropivacaine 0.5%), with less side effects. |
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E.2.2 | Secondary objectives of the trial |
Comparison of the quality of analgesia defined as average VRS score over 24 hours
Time to complete resolution of sensory block and motor block will be analyzed between the two groups.
Comparison the amount of additional pain medication used over a period of 24 hours in both groups
Comparison the overall patient satisfaction regarding the anesthetic technique in both groups
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients > 18 years
Patients undergoing arthroscopy of the shoulder
ASA I – III
German speaking
Able to cooperate in pain assessment |
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E.4 | Principal exclusion criteria |
Patients with a contra-indication for interscalene brachial plexus block
Allergy to ropivacaine or other amide local anesthetics
Preexisting respiratory compromise
Preexisting sensory or motor block
Chronic pain and taking > 30 mg oral morphine or equivalent per day
Participation in another study |
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to first request of analgesia will be the primary endpoint |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Time of request, noted in CRF |
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E.5.2 | Secondary end point(s) |
Comparison of the quality of analgesia defined as average VRS score over 24 hours
Time to complete resolution of sensory block and motor block will be analyzed between the two groups.
Comparison the amount of additional pain medication used over a period of 24 hours in both groups
Comparison the overall patient satisfaction regarding the anesthetic technique in both groups
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
perioperative beginning 120, 180, 240 minutes after brachial plexus block, then every two hours till 10pm. no evaluation during night, beginning again next morning.
over all duration max 24 hrs |
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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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Ropivacaine 0.5% standard of care (20ml) |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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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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 | 1 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 1 |