E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
No specific medical condition is investigated. The objective of the trial is to investigate a method for postoperative analgesia after elective hip surgery. |
Der undersøges ikke en specifik medicinsk tilstand. Studiets formål er at undersøge en metode til smertebehandling efter elektiv hoftekirurgi. |
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E.1.1.1 | Medical condition in easily understood language |
No specific medical condition is investigated. The objective of the trial is to investigate a method for pain treatment after planned hip surgery. |
Der undersøges ikke en specifik medicinsk tilstand. Studiets formål er at undersøge en metode til smertebehandling efter planlagt hoftekirurgi. |
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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 | 19.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068084 |
E.1.2 | Term | Anesthesia procedure |
E.1.2 | System Organ Class | 100000004865 |
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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 |
To estimate the effect of obturator nerve blockade on postoperative opioid consumption 0-12 hours after total hip replacement. |
Estimering af effekten af nervus obturatorius-blokade på det postoperative opioidforbrug 0-12 timer efter total hoftealloplastik. |
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E.2.2 | Secondary objectives of the trial |
To estimate the effect of obturator nerve blockade on: - Postoperative opioid consumtion 12-18 hours after total hip replacement - Postoperative pain at rest and during passive movement after total hip replacement. - Pain during ambulation after total hip replacement. - Time to first opioid dose after total hip replacement. - Postoperative nausea and vomiting after total hip replacement. - The length of stay at post anesthesia care unit after total hip replacement. - The length of admission after total hip replacement. - The patients ability to be mobilized after total hip replacement. - The patients quality of sleep the first night after total hip replacement.
To estimate the duration of spinal anaesthesia aftertotal hip replacement. |
Estimering af effekten af nervus obturatorius-blokade på: - Opioidforbruget 12-18 timer efter total hoftealloplastik. - Postoperativ smerte ved passiv bevægelse og i hvile efter total hoftealloplastik. - Smerte under mobilisering efter total hoftealloplastik. - Tiden til første opioiddosis efter total hoftealloplastik. - Postoperativ kvalme og opkastning efter total hoftealloplastik. - Varigheden af opholdet på observationsafsnit efter total hoftealloplastik. - Indlæggelsens varighed efter total hoftealloplastik. - Patientens evne til mobilisering efter total hoftealloplastik. - Patientens søvnkvalitet den første postoperative nat efter total hoftealloplastik.
Estimering af varigheden af spinalanæstesi efter total hoftealloplastik.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients for primary hip replacement in spinal anesthesia - Age >= 18 years - American Society of Anesthesiologists physical status classification score I-III - Informed consent |
- Patienter indstillet til primær hoftealloplastik i spinalanæstesi - Alder ≥ 18 år - American Society of Anesthesiologists physical status classification score (ASA) I-III - Informeret samtykke |
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E.4 | Principal exclusion criteria |
- Lacking the ability to corporate - Lacking the ability to speak danish - Planned discharge on the same day of surgery - Neuropathy of the lower extremities - Contraindications for NonSteroidal Anti-Inflammatory Drugs (NSAID) - Contraindications for dexamethasone - Chronic opioid demanding pain - Pregnancy - Allergy towards the IMP - Active treatment with amiodarone - Active treatment with verapamil - Active treatment with corticosteroids |
- Manglende evne til samarbejde - Manglende danskkundskaber - Patienter i sammedags-forløb (udskrives samme dag som operationen) - Neuropati i underekstremiteter - Kontraindikationer for non-steroide antiinflammatoriske lægemidler (NonSteroidal Anti-Inflammatory Drugs; NSAID) - Kontraindikationer for dexamethason - Kroniske opioidkrævende smerter - Graviditet - Overfølsomhed for det anvendte lægemiddel - Aktuel behandling med amiodaron - Aktuel behandling med verapamil - Aktuel behandling med kortikosteroider |
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E.5 End points |
E.5.1 | Primary end point(s) |
Cumulated dose of opioid 0-12 hour after total hip replacement. |
Summeret dosis af opioid 0-12 timer efter total hoftealloplastik. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 hours after completion of total hip replacement |
12 timer efter afslutning af total hoftealloplastik |
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E.5.2 | Secondary end point(s) |
1: Cumulated dose of opioid 12-18 hours after total hip replacement. 2: Pain at rest at time of examination (numeric rating scale) 3: Pain at passive hip fleksion to 90 degrees (numeric rating scale) 4: Maksimal pain during ambulation on the day of operation 5: Time from completion of surgery to first dose of opioid 6: Intensity of nausea on time of examination (numeric rating scale) 7: Incidences og emesis 0-18 hours after total hip replacement. 8: Cumulated dose of ondansetron 0-18 hours after total hip replacement. 9: Cumulated dose of droperidol 0-18 hours after total hip replacement. 10: Length of stay on post anesthesia care unit after completion of total hip replacement. 11: Length of stay on hospital after completion of total hip replacement. 12: Ability to ambulate 5 hours after total hip replacement 13: Control with operated extremity during ambulation 5 hours after total hip replacement. 14: Self-reported sleep quality the first night after total hip replacement 15: Duration og spinal anesthesia after total hip replacement. |
1: Summeret opioid-dosis fra 12-18 timer efter operationens afslutning 2: Smerte i hvile på undersøgelsestidspunktet (numerisk vurderingsskala) 3: Smerte ved passiv fleksion af hoften til 90 grader (numerisk vurderingsskala) 4: Værste smerte under mobilisering på operationsdagen 5: Tid til fra afslutningen af total hoftealloplastik til første dosis opioid 6: Intensitet af kvalme på undersøgelsestidspunkt (numerisk vurderingsskala) 7: Antallet af opkastninger de første 18 timer efter total hoftealloplastik. 8: Summeret dosis af ondansetron de første 18 timer efter total hoftealloplastik. 9: Summeret dosis af droperidol de første 18 timer efter total hoftealloplastik. 10: Varighed af postoperativt ophold på observationsafsnit efter total hoftealloplastik. 11: Varighed af ophold på hospital efter total hoftealloplastik. 12: Evne til mobilisering 5 timer efter operationens afslutning 13:Kontrol med opererede ben ved mobilisering 5 timer efter operationens afslutning 14: Selvvurderet søvnkvalitet første postoperative nat efter total hoftealloplastik 15: Varighed af spinalanæstesi efter total hoftealloplastik |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1, 5, 7-10, 14: 24 hours after completion of total hip replacement 2, 3, 6: 1, 2, 5, 7 and 24 hours after completion of total hip replacement 4, 12, 13: 5 hours after completion of total hip replacement 11: After discharge from hospital 15: Every 15 minutes after arrival on post anaesthesia care unit. |
1, 5, 7-10, 14: 24 timer efter afslutning af total hoftealloplastik 2, 3, 6: 1, 2, 5, 7 and 24 timer efter afslutning af total hoftealloplastik 4, 12, 13: 5 timer efter afslutning af total hoftealloplastik 11: Efter udskrivelse fra sygehus 15: Hvert 15. minut efter ankomst til opvågningsafsnit |
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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 | 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 | 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
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |