E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients receiving a primary total shoulder arthroplasty |
|
E.1.1.1 | Medical condition in easily understood language |
patients receiving a primary total shoulder replacement |
|
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 trial is to describe a pharmacokinetic profile of total and unbound plasma concentrations of bupivacaine, when Exparel is used as interscalene nerve block as analgesia for primary total shoulder arthroplasty. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are to describe the postoperative pain (in numeric rating scale), the post operative opiate use and the experienced side effects/(S)AEs. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age ≥18 years
- ASA physical health classification I-II
- Patient planned for a primary unilateral total shoulder arthroplasty or reversed shoulder arthroplasty under total anesthesia with a locoregional anesthetic block
- Hb >7.5 mmol/L
- Written informed consent
|
|
E.4 | Principal exclusion criteria |
- BMI (body mass index) >35kg/m2
- Known hypersensitivity to amide-type local anesthetics
- Chronic use of opiates
- Contraindication for paracetamol, NSAID’s or opiates.
- COPD gold 3-4 or any other pulmonary disease that significantly affects pulmonary function
- Hepatic or renal insufficiency
- Use of fluvoxamine, ciproflocaxine, ketoconazol, erytromycine, claritromycine, itraconazol or rifampicine because of their effect on bupivacaine clearance.
- Inadequate proficiency in Dutch.
- 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 bupivacaine (Cmax)
- Mean time to total and unbound maximum serum concentration of bupivacaine (Tmax) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Befor Surgery and at t 0.5, 1, 2, 4, 8, 12, 24, 26, 48, 72 hours after admission of Exparel |
|
E.5.2 | Secondary end point(s) |
Age, weight, height, gender, co-medication and systemic diseases will be reported as baseline variables. Secondary endpoints: Post-operative pain intensity (NRS), post-operative use of opiates (PCIA morphine) and: side effects, complications and signs of systemic toxicity will be recorded. ((S)AEs)
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline variables: baseline
Secondary endpoint: untill 72 hours postoperative.
If hospital stay is extended due to complications, (S)AEs will be followed untill resolved or recovered with sequalae. |
|
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 | Yes |
E.6.5 | Efficacy | Yes |
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) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
First administration to brachial plexus |
|
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
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 | 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
|
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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |