E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
primary coxarthrosis |
primaire coxarthrose |
|
E.1.1.1 | Medical condition in easily understood language |
degeneration of the hipjoint |
slijtage aan het heupgewricht |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
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 purpose of the research is to determine the difference in pain experience during peace and mobilization, measured by means of an 11-point Numerical Rating Scale (NRS), between peroperatieve Local infiltration with Analgesics (LIA) vs. placebo, 24 hours postoperatively in patients with total hip replacement in the fast-track protocol |
Het primaire doel van het onderzoek is het bepalen van het verschil in pijnbeleving tijdens rust en mobilisatie, gemeten door middel van een 11 punts Numerieke Rating Scale (NRS), tussen peroperatieve Lokale Infiltratie met Analgetica (LIA) vs. placebo, 24 uur postoperatief bij patiënten met een totale heupprothese in het fast-track protocol |
|
E.2.2 | Secondary objectives of the trial |
Secondary objective: a secondary objective of the study is to determine the difference in secondary outcome measures between peroperatieve Local infiltration with Analgesics (LIA) vs. placebo, postoperatively in patients with total hip replacement in the fast-track protocol.
-HOOS (pre OK and 6 WKS post)
-SF12 (Pre OK and 6 WKS post)
-Oxford Hip score (BL and 6 WKS post)
-Length of stay
-Presence of nausea, vomiting, bladder retention
-Complications
-Use analgesics: PCA-use/opiates |
Het secundaire doel van het onderzoek is het bepalen van het verschil in secundaire uitkomstmaten tussen peroperatieve Lokale Infiltratie met Analgetica (LIA) vs. placebo, postoperatief bij patiënten met een totale heupprothese in het fast-track protocol
- HOOS (pre OK en 6 WKS post)
- SF12 (Pre OK en 6 WKS post)
- Oxford Hip score (BL en 6 WKS post)
- Opnameduur
- Aanwezigheid van misselijkheid, braken, blaasretentie
- Complicaties
- Gebruik analgetica: PCA-gebruik/opiaten |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-in writing given informed consent
-over 18 years of age
- operation indication: primary coxarthrosis
-Dutch speaking and understanding
-Spinal anaesthesia
-patients who go home after surgery (secondary outcome length of stay) |
- schriftelijk gegeven informed consent
- ouder dan 18 jaar
- operatie indicatie: primaire coxartrose
- Nederlands sprekend en begrijpend
- spinaal anaesthesie
- patiënten die postoperatief naar huis gaan (secundaire uitkomst opnameduur)
|
|
E.4 | Principal exclusion criteria |
-Patients who within 12 months prior to the surgery were opioid-dependent.
-malignancies.
-Patients with co-morbidities which may affect the possible pain perception (in the prehistory: CVA or a psychiatric disorder).
-Patients with allergies to ropivacaine
-ASA 3-4
-Patients with a peroperatieve complication occurs which interferes with the normal mobilization and pain experience (fractures, vascular/nerve injury
|
- Patiënten die binnen 12 maanden voorafgaand aan de operatie opioid-afhankelijk waren.
- maligniteiten.
- Patiënten met co-morbiditeit die mogelijk de pijn perceptie kunnen beïnvloeden (in de voorgeschiedenis: CVA of een psychiatrische aandoening).
- Patiënten met allergieën voor ropivacaine
- ASA 3-4
- Patiënten waarbij een peroperatieve complicatie optreedt die interfereert met de normale mobilisatie en pijn beleving (fracturen, vaat-/ zenuwletsel |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the NRS pain score 24 hours postoperatively at rest and during mobilization |
Het primaire eindpunt is de NRS pijnscore 24 uur postoperatief in rust en tijdens mobiliseren. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
24 hours postoperatively |
24 uur postoperatief |
|
E.5.2 | Secondary end point(s) |
Secondary endpoints are the-NRS scores for pain (from 24 hours) to 48 hours postoperatively
-HOOS (pre OK and 6 WKS post)
-SF12 (pre OK and 6 WKS post)
-Oxford Hip score (pre OK and 6 WKS post)
-length of stay
-Presence of nausea, vomiting, bladder retention
-Complications
-Use analgesics: PCA-use/opiates |
Secundaire eindpunten zijn de
- NRS scores voor pijn (vanaf 24 uur) tot en met 48 uur postoperatief
- HOOS (pre OK en 6 WKS post)
- SF12 (pre OK en 6 WKS post)
- Oxford Hip score (pre OK en 6 WKS post)
- Opnameduur
- Aanwezigheid van misselijkheid, braken, blaasretentie
- Complicaties
- Gebruik analgetica: PCA-gebruik/opiaten |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
48 hours postoperatively and 6 weeks postoperatively |
48 uur poatoperatief en 6 weken postoperatief |
|
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 | 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 | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
placebo gecontroleerd |
placebo controlled |
|
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.8.5 | 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 trial is the last visit of the last subject undergoing the trial |
Het einde van de studie is na de laatste vist van de laatste proefpersoon |
|
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 | 3 |
E.8.9.1 | In the Member State concerned days | |