E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients who will undergo reconstruktion of ligament cruciate ligament. |
Patienter der skal have foretaget en korsbånds rekonstruktion |
|
E.1.1.1 | Medical condition in easily understood language |
Patients who will undergo reconstruktion of ligament cruciate ligament. |
Patienter der skal have foretaget en korsbånds rekonstruktion |
|
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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036236 |
E.1.2 | Term | Postoperative pain relief |
E.1.2 | System Organ Class | 100000004865 |
|
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 purpose of this study is to investigate the analgesic effect of BAC in patients with moderate to severe pain (VAS ≥ 40 mm) after reconstruction of the anterior cruciate ligament (hamstring graft). The hypothesis is that the BAC will reduce post-operative pain, maintain muscle strength, and to reduce the post-operative use of opioid compared to placebo. The purpose of the study is therefore to clarify whether BAC can and should be used in the subgroup of patients who have moderate to severe pain after cruciate ligament |
Formålet med dette studie er at undersøge den analgetiske effekt af AKB hos patienter med moderate til stærke smerter (VAS ≥40mm) efter rekonstruktion af forreste korsbånd, (hamstring graft). Hypotesen er at AKB vil reducere postoperative smerter, bevare muskel-styrken, samt mindske det postoperative forbrug af opioid sammenlignet med placebo. Formålet med studiet er således også at få afklaret, om AKB kan og bør anvendes hos den subgruppe af patienter, der har moderate til stærke smerter efter korsbåndsoperation.
|
|
E.2.2 | Secondary objectives of the trial |
Not applicable |
Not applicable |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age> 18 years and <80 years • Patients in the recovery ward (before discharge to home) indicates a postoperative VAS score ≥ 40 at 45 degrees inward inflexion of the knee after reconstruction of the anterior cruciate ligament (ACL) with a hamstring graft with general anesthesia and without administration of opioid in the last 30 minutes before inclusion. • Patients who have given written informed consent to participate in the study after having understood the contents of the protocol and limitations in full. • ASA I-III. • BMI> 18 and <40 |
• Alder > 18 år og < 80 år • Patienter som i opvågningsafsnittet (før udskrivelse til hjemmet) tilkendegiver en postoperativ VAS-score ≥40 ved 45 graders aktiv flektion af knæled efter rekonstruktion af forreste korsbånd (ACL) med hamstring graft i universel anæstesi og uden indgift af opioid de sidste 30 minutter før inklusion. • Patienter, som har givet deres skriftlige informerede samtykke til at deltage i undersøgelsen efter at have forstået protokollens indhold og begrænsninger fuldt ud. • ASA I-III. • BMI > 18 og < 40
|
|
E.4 | Principal exclusion criteria |
Patients who are operating in blood emptiness (used a cuff) • Patients who can not cooperate with the investigation. • Patients who do not understand or speak Danish. • Allergy to those used in the study drugs. • Pregnancy, studied with HCG urinstiks on the day of surgery when possible pregnancy. • Alcohol and / or drug abuse - the investigator's opinion. • Daily consumption of opioid • Infection at the injection area |
• Patienter, som er opereret i blodtomhed (anvendt blodtomheds-manchet) • Patienter som ikke kan samarbejde til undersøgelsen. • Patienter som ikke forstår eller taler dansk. • Allergi over for de i undersøgelsen anvendte stoffer. • Graviditet, undersøgt med HCG-urinstiks på operationsdagen ved mulig graviditet. • Alkohol- og/eller medicinmisbrug – efter investigators skøn. • Dagligt forbrug af opioid • Infektion ved indstiksområdet
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
• Forskel i smertescore ved 45 graders aktiv flektion af knæled 45 minutter (t45) efter anlæggelse af AKB med 30 mL ropivacain 7.5 mg/mL versus placebo |
The difference in pain scores at 45 degrees inward inflexion of knee 45 minutes (t45) after the construction of BAC with 30 mL of ropivacaine 7.5 mg / mL versus placebo |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
painscore at the time 45 and 90 minutes after studydrug has been given
|
Smertescore til tiden 45 og 90 min efter indgift af studydrug |
|
E.5.2 | Secondary end point(s) |
The difference in pain scores at rest 45 minutes (t45) after the construction of BAC with 30 mL of ropivacaine 7.5 mg / mL versus placebo. • The difference in pain scores at 45 degrees inward inflexion of knee 90 minutes (t90) after the construction of BAC between the two treatment groups • The difference in pain scores at rest 90 minutes (t90) after the construction of BAC between the two treatment groups • Maximum pain (VAS) for 5 meter walk and with full load on the operated leg at times t45 and t90 • Patient assessment of change in muscle strength after BAC assessed within the 5 meter walk to the times t45 and t90 |
Forskel i smertescore i hvile 45 minutter (t45) efter anlæggelse af AKB med 30 mL ropivacain 7.5 mg/mL versus placebo. • Forskel i smertescore ved 45 graders aktiv flektion af knæled 90 minutter (t90) efter anlæggelse af AKB imellem de to behandlingsgrupper • Forskel i smertescore i hvile 90 minutter (t90) efter anlæggelse af AKB imellem de to behandlingsgrupper • Maksimal smerte (VAS) i forbindelse med 5 meters gang og med fuld belastning på det opererede ben til tiderne t45 og t90 • Patientens vurdering af ændring af muskelstyrken efter AKB vurderet i forbindelse med 5 meters gang til tiderne t45 og t90
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
painscore at the time 45 and 90 minutes after studydrug has been given |
Smertescore til tiden 45 og 90 min efter indgift af studydrug |
|
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 | Yes |
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
|
It is planned to include 50 patients - studydrug will bee given at painscore VAS ≥40mm at the time = 0 - LPLV is 24 hours after last dose of study drug. |
Det er planlagt at inkludere 50 patienter - studydrug bliver givet ved smertescore VAS ≥40mm ved tiden =o - LPLV er 24 timer efter sidste dosis study drug. |
|
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 | |