E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Our hypothesis is that a longitudinal approach to the fascia iliaca with a larger volume of local anesthetic will decrease morphine consumption and pain scores in patients after total hip arthroplasty compared to a control group.
We will test our hypothesis in a double blind, randomized, placebo controlled trial.
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E.1.1.1 | Medical condition in easily understood language |
Hip replacement needs a good postoperative pain management. We want to investigate if a regional technique as there is a fascia iliaca block can reduce postoperative pain. |
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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 | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10044088 |
E.1.2 | Term | Total hip replacement |
E.1.2 | System Organ Class | 100000004865 |
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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 primary endpoint of the study will be total morfine consumption during the first 24 hours.
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E.2.2 | Secondary objectives of the trial |
Secondary endpoints will be morphine consumption at 48 hours, pain scores, postoperative nausea and vomiting and number of blocked nerves using respons to pinprick in the sensory territories of the different nerves (femoral, obturator and lateral cutaneous). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
After obtaining written, informed consent patients presenting for primary THA will be included in the study. |
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E.4 | Principal exclusion criteria |
Exclusion criteria will be age <18years, BMI>35, intolerance to any of the drugs used in the study, opioid dependency and coagulopathy. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of the study will be total morfine consumption during the first 24 hours. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Total Morphine consumption at 24 hours. |
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E.5.2 | Secondary end point(s) |
Secondary endpoints will be morphine consumption at 48 hours, pain scores, postoperative nausea and vomiting and number of blocked nerves using respons to pinprick in the sensory territories of the different nerves (femoral, obturator and lateral cutaneous). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Total Morphine consumption at 48 hours. |
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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 | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
longitudinal fascia ilaca compartment block versus no block |
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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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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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last visit, last subject, |
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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 | |