E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients scheduled for single shot axillary brachial plexus block for hand, wrist, or forearm orthopedic surgery |
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E.1.1.1 | Medical condition in easily understood language |
nerve block for hand, wrist, or forearm 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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038286 |
E.1.2 | Term | Regional nerve block |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 |
The purpose of the present study is to determine the effect of mepivacaine dose and volume on the duration of sensory axillary brachial plexus block (overall and individual nerves). |
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E.2.2 | Secondary objectives of the trial |
The effect of dose and volume on: duration of motor block (overall and individual nerves); onset of sensory and motor block (overall and individual nerves); Time To First Request of postoperative analgesia (TTFR); and satisfaction (NRS 0-10) with anesthetic technique |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients ≥ 18 years
- ASA physical status classification I – III
- Patients undergoing single shot ABPB for hand, wrist, or forearm orthopedic surgery
- Written informed consent
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E.4 | Principal exclusion criteria |
- Contra-indications for regional anesthesia
- Known hypersensitivity to amide-type local anesthetics
- Known history of peripheral neuropathy
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E.5 End points |
E.5.1 | Primary end point(s) |
Duration of sensory ABPB (overall and individual nerves). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Block duration will be tested every 15 minutes postoperatively in patients who participate in this study until the block has resolved completely (approximately 6h after injection of loading dose) |
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E.5.2 | Secondary end point(s) |
Duration of motor block (overall and individual nerves)
Onset of sensory and motor block (overall and individual nerves),
Time to first request for postoperative analgesia
Satisfaction (NRS 0-10) with the anesthetic technique
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Block duration will be tested every 15 minutes postoperatively in patients who participate in this study until the block has resolved completely (approximately 6h after injection of loading dose)
Onset will be assessed every 5 minutes during 30 minutes after initial loading dose
Time To First Request for postoperative analgesia and satisfaction with the anesthetic technique will be assessed upon conclusion of the study (time is as the block has resolved completely, approximately 6h after injection of loading dose)
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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 | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 | 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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
same local anesthetic, different dose or volume |
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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
| 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 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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |