E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Surgery of the shoulder and/or upper extremity using interscalene brachial plexus block |
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E.1.1.1 | Medical condition in easily understood language |
Surgery of the shoulder and/or upper arm using anesthesia of the nerves supplying it |
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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 |
The aim of this study is to confirm that the frequency of epidural spread correlates with higher volumes of local anesthetic injection (5ml vs 20ml) after interscalene brachial plexus block. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives include evaluation of block effectiveness, duration, incidence of side effects, and patient satisfaction. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age between 18 and 75 years - Surgery of the shoulder (shoulder arthroscopy, open shoulder joint surgery, rotator cuff surgery, tendon transfer, shoulder arthroplasty, humerus fracture surgery) - Informed consent to participate in the study - American Society of Anesthesiologists physical score I, II or III |
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E.4 | Principal exclusion criteria |
- Refusal to participate in the study - Inability to understand the study protocol due to language barrier - Serious cardiac or pulmonary disease such as decompensated heart failure, recent myocardial infarction (less than one month in the past), heart block greater than 2nd degree, obstructive sleep apnea and chronic obstructive lung disease greater than 2nd degree - renal impairment with an aGFR < 60ml/min - Hypersensitivity to ropivacaine or gadolinium or other contraindications against peripheral nerve blocks - Chronic opioid usage greater than 15 mg oral morphine equivalents daily, the daily use of adjunctive pain medications (gabapentinoids, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors) - Schizophrenia or bipolar disorders, uncontrolled anxiety, claustrophobia - Peripheral neuropathy - Hepatic or renal impairment - Ongoing illicit drug or alcohol abuse - Metal implants or other contraindications for magnetic resonance imaging - Coagulopathy - Participation in additional clinical trials within 4 weeks before screening - Hearing impairment - Pregnancy |
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E.5 End points |
E.5.1 | Primary end point(s) |
Spread of local anesthetics to the epidural space |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
immediately after block placement |
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E.5.2 | Secondary end point(s) |
- Contralateral epidural spread. - Spread of local anesthetics to the phrenic nerve. - Bed side spirometry and ultrasound investigation of the diaphragm in the PACU. - Oxygen saturation in the PACU - Self-reported block duration. - Self reported pain scores for the first 24 postoperative hours - Time to first analgesic consumption on demand. - Total analgesic consumption (ropivacaine PCA). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
immediately after block placement before block placement, post surgery, at 4h, 8h, 10h, 12h, 14h, on postop day 1 |
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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 | Yes |
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 |
two different volumes (5ml and 20ml) will be compared |
|
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.8.5 | 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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |