E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postoperative pain after hip arthroscopy |
Postoperative smerter efter hofte artroskopi |
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E.1.1.1 | Medical condition in easily understood language |
Pain after hip arthroscopy |
Smerter efter kikkert operation af hoften |
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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 | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10080604 |
E.1.2 | Term | Hip arthroscopy |
E.1.2 | System Organ Class | 100000004848 |
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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 the trial is to assess the analgesic effect of preoperatively placed active or placebo iliopsoas plane block for elective primary hip arthroscopy. The primary objective of the study is to investigate morphine consumption |
Formålet er at vurdere analgetisk effekt af præoperativt anlagt aktiv eller placebo iliopsoas plane blokade til elektiv primær hofteartroskopi. Forsøgets primære mål er at undersøge morfinforbrug. |
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E.2.2 | Secondary objectives of the trial |
The secondary goal are to investyigate pain and morphine side effects. |
Dert sekundære mål er at undersøge postoperative smerter og morfinbivirkninger. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Set for elective primary hip arthroscopy by one single otrhopedic surgeon • Planned generel anesthesia with Propofol og Remifentanil • ASA I-III • Patient ≥ 18 years • Informeret consent
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• Indstillet til elektiv primær hofteartroskopi ved en og samme ortopædkirurg • Planlagt generel anæstesi med Propofol og Remifentanil • ASA I-III • Patient ≥ 18 år • Informeret samtykke
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E.4 | Principal exclusion criteria |
• Inability to cooperate • Unable to speak and/or understand Danish or other types of communication problems • Allergy to local analgesics in the study (Marcain + adrenaline) • Lack of tolerance of both Morphine and Oxycodone • Chronic pain with daily opioid consumption (dosed > x 1Day) • Chronic pain and treatment with gabapentin, pregabalin, tricyclic antidepressants, opioid antagonists or SNRI • Treatment with antipsychotics • Known abuse of alcohol, drugs or medicine • Previous hip surgery on the planned site for this hip artroscopy • Previous participation in this study • Pregnancy |
• Manglende evne til at samarbejde • Manglende kundskaber til at tale og forstå dansk eller andre former for kommunikationsproblemer • Allergi over for anvendte lokalanalgetika i undersøgelsen (Marcain + Adrenalin). • Manglende tolerance over for både Morfin og Oxycodon angivet af patienten ved forespørgsel • Kroniske smerter med dagligt opioidforbrug (doseret > x 1dgl) • Kroniske smerter og i behandling med gabapentin, pregabalin, tricykliske antidepressiva, opioidantagonoister eller SNRI præparater. • Behandling med antipsykotika • Kendt misbrug af alkohol, stoffer eller medicin • Tidligere hofteopereret på den planlagte side for denne hofteartroskopi • Tidligere deltagelse i dette studie (ved operation på modsatte side) • Graviditet. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Cumulative opioid consumption by PCA pump (patient controlled analgesia) in the first 180 min in PACU after primary hip arthroscopy for patients with active or placebo iliopsoas plane blockade. |
Kumuleret opioidforbrug (mg) ved PKA-pumpe (patient kontrolleret analgesi) i de første 180 min i PACU efter primær hofteartroskopi for patienter med aktiv eller placebo iliopsoas plane blokade. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
180 min. after arrival to PACU |
180 min. efter ankost til PACU. |
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E.5.2 | Secondary end point(s) |
• Pain Score (NRS 0-10, where 0 is no pain and 10 the worst possible pain) in the hip at rest assessed on arrival at PACU and then every 30 minutes the next 180 min. where the patient remains in PACU. • Pain Score (NRS 0-10) in the hip by activity (flexion at the hip joint to 45 degrees), assessed on arrival at PACU and then every 30 minutes the next 180 min. where the patient remains in PACU. • Nausea score assessed on a scale (no, mild, moderate, pronounced) assessed on arrival at PACU and then every 30 minutes the next 180 min. where the patient remains in PACU. • Number of vomiting the first 180 min. The patient is in PACU. • Length of stay (LOS) measured in minutes in PACU. The period is registered from arrival to PACU until the patient is ready for discharge. After the first 180 min in PACU, this is assessed every 30 minutes where the patient remains in PACU. • Total morphine consumption in PACU during the first 180 min in PACU. • The force of the quadriceps muscles on the operated limb was tested with a dynamometer before the nerve blockade and after 180 min observation in PACU. • Patient satisfaction with pain treatment at the time of discharge (NRS 0-10, where 0 is very dissatisfied and 10 is very satisfied). |
•Smertescore (NRS 0-10, hvor 0 er ingen smerte og 10 den værst tænkelige smerte) i hoften i hvile vurderet ved ankomst til PACU og derefter hvert 30. min. de næste 180 min. hvor patienten forbliver i PACU. •Smertescore (NRS 0-10) i hoften ved aktivitet (fleksion i hofteleddet til 45 grader) vurderet ved ankomst til PACU og derefter hvert 30. min. de næste 180 min. hvor patienten forbliver i PACU. •Kvalmescore vurderet på en skala (ingen, let, moderat, udtalt) vurderet ved ankomst til PACU og derefter hvert 30. min. de næste 180 min. hvor patienten forbliver i PACU. •Antal af opkastninger de første 180 min. patienten er i PACU. •Varighed af ophold (LOS) målt i minutter i PACU. Perioden registreres fra ankomst til PACU til patienten er klar til udskrivelse. Efter de første 180 min i PACU vurderes dette hvert 30. min hvor patienten forbliver i PACU. •Samlet morfinforbrug i PACU i løbet af de første 180 min i PACU. •Kraften i quadricepsmuskulaturen på den opererede underekstremitet testes med et dynamometer før nerveblokade og efter 180 min observation i PACU. •Patienttilfredshed med smertebehandlingen på udskrivelsestidspunktet (NRS 0-10, hvor 0 er meget utilfreds og 10 er meget tilfreds).
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Assessed upon arrival at PACU and the every 30 min the next 180 min where the patient remains in the PACU |
Vurderet ved ankomst til PACU og derefter hvert 30 mion. de næste 180 min. hvor patienten forbliver i PACU. |
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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 | Yes |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |