E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients receiving primary total knee replacement |
|
E.1.1.1 | Medical condition in easily understood language |
patients receiving total knee arthroplasty |
|
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 primary objective of this study is to describe a pharmacokinetic profile of total and unbound plasma concentrations of ropivacaine, when used in the LIA technique for the knee. |
|
E.2.2 | Secondary objectives of the trial |
A secondary objective of this study is to compare the pharmacokinetic profiles of total and unbound ropivacaïne and analyse its relationship. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- age 50-80 years - ASA physical health classification I – II - Body Mass Index (BMI) < 40 - patient planned for a primary unilateral posterior-stabilized tri-compartmental cemented total knee replacement (Genesis II - PS) under unilateral spinal anesthesia with 2 mL hyperbaric bupivacaine 0.5% - scheduled for fast-track protocol TKA - haemoglobin (Hb) concentration ≥ 7.5 mMol/L - written informed consent
|
|
E.4 | Principal exclusion criteria |
- Placement of a surgical drain - Contra-indications for spinal anesthesia - Known hypersensitivity to amide-type local anesthetics - Hepatic or renal insufficiency - Use of fluvoxamine, ciprofloxacin, ketoconazole, erythromycin, clarithromycin, itraconazole, or rifampicin because of their effect on ropivacaine clearance. - Any other reason which in the opinion of the investigator makes the patient unsuitable for participation in the study
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
- Mean total and unbound maximum serum concentration of ropivacaine (Cmax) - Mean time to total and unbound maximum serum concentration of ropivacaine (Tmax)
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Before surgery, and at 20, 40, 60, 90, 120, 240, 360 minutes and 24 hours after release of the tourniquet. |
|
E.5.2 | Secondary end point(s) |
Age, weight, height, gender, co-medication, complications and signs of systemic toxicity will be recorded. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
pre-operatively and post-operatively (t=24 hours) |
|
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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
|
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 | No |
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
|
The end of the study is defined as the last patient’s last sampling |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |