E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Symptoms and general pathology [C23] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10000081 |
E.1.2 | Term | Abdominal pain |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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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 |
We want to conduct a non-inferiority study to compare the use of high concentration to low concentration of Ropivacain. Primary outcome is the postoperative need for morphine. |
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E.2.2 | Secondary objectives of the trial |
Comparing high dose Ropivacain with moderate dose regarding days until discharge, lower limb weakness, nausea/vomiting and pain intensity. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Scheduled for percutaneous nephrolithotomy
• Males/females
• Aged > 18 years
• American Society of Anesthesiology (ASA) physical status 1 - 3
• Legally competent
• Fertile women using contraception OR a negative pregnancy test (HCG)
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E.4 | Principal exclusion criteria |
• Age < 18 years
• ASA physical status ≥4
• Allergic to local anesthetics
• Tattoos, infection or other abnormalities at the site of injection
• No informed consent or inability to give that
• Pre-existing use of opioids
• Pregnant women
• Severe liver disease
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E.5 End points |
E.5.1 | Primary end point(s) |
• Dose of opioids/morphine at PACU
• Dose of opioids/morphine at the ward
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Postoperative:
6h
12h
24h |
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E.5.2 | Secondary end point(s) |
• Bleeding, volume (ml)
• Amount of anesthetics, narcotic analgesics and other adjuvants
• NRS in the PACU after 15m, 30m and 1h
• NRS in the ward at 6h, 12h and 24h after ended surgery
• Nausea scale in the PACU assessed at 15m, 30m and 1h.
• Vomiting at the PACU
• Antiemetics at the PACU
• PACU stay (minutes)
• Time to discharge (hours/days)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Postoperative:
15min
30min
1h
6h
12h
24h |
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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 | No |
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 | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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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 |
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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.8.5 | 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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The trial is ended when the last participant is discharged from the hospital after surgery. It is planned to include 28 patients in 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 | |
E.8.9.1 | In the Member State concerned days | |