E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
In the present investigation, we will compare the perioperative subanesthetic infusion of ketamine with placebo in opioid-resistant patients undergoing major orthopedic surgery. By powering the study to detect possible differences in the most relevant outcomes, we aim at clarifying whether ketamine should be admistered routinely in this clinical setting. |
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E.1.1.1 | Medical condition in easily understood language |
In the present investigation, we will compare the perioperative subanesthetic infusion of ketamine with placebo in opioid-resistant patients undergoing major orthopedic 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 |
In the present investigation, we will compare the perioperative subanesthetic infusion of ketamine with placebo in opioid-resistant patients undergoing major orthopedic surgery. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients receiving opioid therapy at least three months due to chronic pain or as a drug substitution, acutely undergoing major elective orthopedic surgery will be studied. Written informed consent will be obtained by all patients, on a form entitled “Patient information and declaration of consent” (Patienteninformation und Einverständniserklärung) before inclusion into the study. |
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E.4 | Principal exclusion criteria |
opioid therapy < 3 months, any contraindication to ketamine or morphine, age < 18 yr, pregnancy or nursing, intake of psychotropic drugs, significant neurological or psychiatric disorders unrelated to the chronic pain, other severe pain that might impair the assessment of the surgical pain and lack of patient’s cooperation. |
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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 |
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E.5.2 | Secondary end point(s) |
side effects, additional drugs used to treat pain and side effects, duration of Patient Controlled Analgesia (PCA) use. 1. Time to first mobilization, quality of mobilization using actigraphy, 2. Sleep quality: Actigraphic parameters sleep latency, sleep efficiency, total sleep time during observed pain therapy period. 3. Circadian rhythm: Actigraphic parameters amplitude and peak of the circadian rhythm, intra-daily stability/variability during observed pain therapy period. 4. Treatment costs, hospital length of stay. 5. Number of patients with reduction of chronic pain therapy 3 and 6 months |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |