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 | 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 |
• Opioid consumption at 24 hours (mean cumulative opioid consumption) • Opioid consumption at 6 hours after extubation (mean cumulative opioid consumption)
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E.2.2 | Secondary objectives of the trial |
• Pain intensity (NRS, 0-10) in the surgical area at rest and coughing at 1, 3, 6, 24, 48 and 72 hours after extubation • Pain intensity (NRS 0-10) in the legs (left and right, respectively) at 24 and 48 hours • Patient satisfaction (NRS, 0-10) with pain management at 24 hours after extubation • Nausea and/or vomiting (PONV) on a 4 point Likert scale (none/mild/moderate/severe) at 6 and 24 hours • Time from arrival to readiness for discharge from PACU (hours and minutes). • Level of sedation at observation at the PACU (Ramsay Sedation Scale) at 1 hour after extubation • Any adverse events during observation at the PACU: o Hypoventilation (respiratory rate < 10/minutes) o Hypoxemia (peripheral oxygen saturation < 94%) • Given treatment accordin to patient and investigator (24h) • 3 months follow-up: EQ-5D, opioid consumption and pain intensity
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All patients (≥18 years) scheduled for elective spine surgery are screened for inclusion. |
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E.4 | Principal exclusion criteria |
• Allergy to study drugs • American Society of Anaesthesiologists (ASA) physical status IV or V • Prolonged QTc-interval assessed by electrocardiogram (Male: >450 milliseconds, Female: >460 milliseconds) • Inability to provide informed consent • Severe respiratory insufficiency (Oxygen treatment at home) • Heart failure • Acute alcohol intoxication/delirium tremens • Increased intracranial pressure • Acute liver disease • Acute abdominal pain • Liver insufficiency • Kidney insufficiency (eGFR<30) • Pregnancy or breastfeeding • Existing treatment with medications prolonging the QT-interval (see appendix for details) • Existing treatment with opioids (at least the last 7 days) exceeding 60 mg morphine equivalents daily • Planned postoperative treatment with epidural analgesics and/or ketamine infusion • Treatment with rifampicin • Spinal surgery due to malignant disease
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At 6 and 24 hours after extubation |
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E.5.2 | Secondary end point(s) |
• Pain intensity (NRS, 0-10) in the surgical area at rest and coughing • Pain intensity (NRS 0-10) in the legs (left and right, respectively) • Patient satisfaction (NRS, 0-10) with pain management • Nausea and/or vomiting (PONV) on a 4 point Likert scale (none/mild/moderate/severe) • Time from arrival to readiness for discharge from PACU (hours and minutes). • Level of sedation at observation at the PACU (Ramsay Sedation Scale) • Any adverse events during observation at the PACU: o Hypoventilation (respiratory rate < 10/minutes) o Hypoxemia (peripheral oxygen saturation < 94%) • Given treatment accordin to patient and investigator • Follow-up: EQ-5D, opioid consumption and pain intensity
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Pain intensity, back: 1, 3, 6, 24, 48 and 72 hours after extubation Pain intensity, legs: 24 and 48 hours Patient satisfaction: 24 hours after extubation PONV: 6 and 24 hours Sedation: 1 hours Given treatment: 24 hours Followup: 3 months |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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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3 months following LVLS (due to followup) |
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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 | |