E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of postoperative pain in patients after total knee arthroplasty |
Behandling af postoperative smerter hos patienter, der har gennemgået
total knæalloplastik |
|
E.1.1.1 | Medical condition in easily understood language |
Treatment of postoperative pain in patients after total knee arthroplasty |
Behandling af smerter hos patienter, der har fået indsat et nyt knæled |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
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 |
Treatment of postoperative pain after total knee arthroplasty |
Behandling af postoperative smerter hos patienter, der har gennemgået total knæalloplastik |
|
E.2.2 | Secondary objectives of the trial |
no secondary objectives |
ingen sekundære objectives |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age > 30 and < 85 years
- Total knee arthroplasty in spinal anaesthesia at Gentofte Hospital
- Informed consent
- ASA 1-3
- BMI >18 and <40 |
• Alder > 30 år og < 85 år
• Patienter indstillet til total knæalloplastik i spinal anæstesi
• Patienter, som har givet deres skriftlige informerede samtykke til at
deltage i undersøgelsen efter at have forstået denne.
• ASA 1-3
• BMI > 18 og < 40 |
|
E.4 | Principal exclusion criteria |
- Unable to corporate.
- Unable to speak or understand Danish
- Allergy to ropivacaine
- Known medical or alcohol-abuse
- Known peripheral neuopathy
- Daily consumption af strong opioids
- Pregnancy |
- Patienter som ikke kan samarbejde til undersøgelsen.
- Patienter som ikke forstår eller taler dansk.
- Allergi over for de i undersøgelsen anvendte stoffer.
- Alkohol- og/eller medicinmisbrug – efter investigators skøn.
- Kendte føleforstyrrelser i underekstremiteterne.
- Dagligt forbrug af stærke opioider
- Graviditet
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Difference between groups in pain intensity during active 45 degrees knee flexion - 24 hours after surgery, measured on VAS (0-100) |
Forskellen i smertescore (VAS) ved aktiv 45 graders fleksion af
knæleddet til tiden 24 timer efter sidste sutur |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
24 hours after last suture |
24 timer efter sidste sutur |
|
E.5.2 | Secondary end point(s) |
- Difference between groups (VAS measured at rest as AUC 0-24 hours)
at time points: 2, 4, 6, 8, 24 hours postoperatively.
- Difference between groups (VAS measured at 45 degrees active knee
flexion as AUC 0-24 hours) at time points: 2, 4, 6, 8, 24 postoperative
hours.
- Time to perform a TUG (Timed Up and Go) test 24 hours after surgery.
- Difference between groups in cumulated morphine consumption, first
24 hours. Morphine administered as PCA.
- Difference between groups in mean nausea-score at time 2, 4, 6, 8, 24
postoperative hours.
- Difference between |
-Forskellen i smertescore (VAS) i hvile målt som AUC 0-24 timer efter
sidste sutur. AUC på baggrund af målinger til tiderne 2, 4, 6, 8 og 24
timer efter sidste sutur.
-Forskellen i smertescore (VAS) ved aktiv 45 graders fleksion af
knæleddet målt som AUC 0-24 timer efter sidste sutur. AUC på baggrund
af målinger til tiderne 2, 4, 6, 8 og 24 timer efter sidste sutur.
-Tiden til TUG-test 24 timer efter sidste sutur.
-Kumuleret morfinforbrug de første 24 timer postoperativt,
administreret som patientkontrolleret smertebehandling (bolus 2,5 mg
i.v., lock-out tid 10 minutter).
-Graden af kvalme til tiderne 2, 4, 6, 8 og 24 timer, beregnet som
gennemsnitsværdien for hele perioden.
-Kumuleret forbrug af antiemetika de første 24 timer postoperativt. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
2, 4, 6, 8 and 24 hours after last suture |
2, 4, 6, 8 og 24 timer efter sidste sutur |
|
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 | 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.8.5 | 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
|
We plan to include 100 patients - study drug/placebo will be given 1, 7, 15 and 23 hours after last suture and LPLV is 8 hours after last injection of study drug/placebo. |
we planlægger at inkludere 100 patienter, der vil modtage medicin 1, 7, 15 og 23 timer efter sidste sutur. LPLV er 8 timer efter sidste injektion. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |