E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Post-operative pain after four types of major ankle and hind foot surgery: (1) total ankle arthroplasty, (2) ankle arthrodesis, (3) subtalar arthrodesis or (4) triple arthrodesis |
Postoperative smerter efter fire typer af stor ankel- og bagfodskirurgi: (1) ankelalloplastik, (2) ankelartrodese, (3) subtaloartrodese eller (4) tripleartrodese |
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E.1.1.1 | Medical condition in easily understood language |
Patients' pains after major ankle and foot surgery defined as a total ankle replacement or a fusion of the joint. |
Patienternes smerter efter stor ankel- og bagfodskirurgi defineret som indsættelse af kunstigt ankelled eller stivgørende operation af leddet. |
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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 | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003396 |
E.1.2 | Term | Arthroplasty NOS |
E.1.2 | System Organ Class | 100000004865 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10016962 |
E.1.2 | Term | Foot arthrodesis |
E.1.2 | System Organ Class | 100000004865 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002540 |
E.1.2 | Term | Ankle arthrodesis |
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 |
The main objective is to conduct a prospective, randomized, controlled, double-blinded trial to compare subsartorial saphenous block with bupivacaine-adrenaline vs. placebo to investigate the effect of a saphenous block as a supplement to a continious sciatic catheter on postoperative pain following major ankle surgery. |
Formålet med undersøgelsen er at gennemføre en prospektiv, randomiseret, kontrolleret, dobbeltblindet sammenligning af éngangsblokade af n. saphenus subsartorialt midt på låret med henholdsvis placebo og bupivacain-adrenalin for at undersøge effekten af saphenusblokade som supplement til ischiadicusblokade efter stor ankel- og bagfodskirurgi.
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E.2.2 | Secondary objectives of the trial |
Sensory test of the infrapatellar branch as a proxy marker for analgesia of the saphenous nerve. |
Sensorisk test af r. infrapatellaris som proxymarkør for analgesi af n. saphenus. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Elective ankle or hind foot surgery either (1) total ankle arthroplasty, (2) ankle arthrodesis (3) subtalar arthrodesis, (4) triple arthrodesis - Age ≥ 18 - ASA I-III - Informed consent both orally and in writing after the patient has fully understood the protocol and its limitations. |
- Elektiv bagfods- og/eller ankelkirurgi enten (1) ankelalloplastik, (2) ankelartrodese (ikke-artroskopisk), (3) subtaloartrodese eller (4) tripleartrodese - Alder ≥ 18 år - ASA I-III - Mundtligt og skriftligt informeret samtykke til deltagelse i undersøgelsen efter at have forstået protokollens indhold og begrænsninger fuldt ud |
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E.4 | Principal exclusion criteria |
- Communication problems or dementia - Allergies to any medical product used in the study - Neuropathy of the sciatic or femoral nerve prior to the operation - Morbus Charcot-Marie-Tooth disease, diabetic neuropathy, peripheral vascular disease - Daily use of opioids - Coagulation disorders - Infection at the site of injection or systemic infection |
- Kommunikationsproblemer eller demens - Allergi overfor lægemidler anvendt i undersøgelsen - Præoperativ n. ischiadicus eller n. femoralis neuropati - Præoperativ nedsat kraft eller sensorik i operationsekstremiteten - Morbus Charcot-Marie-Tooth, diabetisk neuropati, svær perifer vaskulær sygdom - Dagligt forbrug af opioider - Koagulationsforstyrrelser - Infektion sv.t. indstiksstedet eller systemisk infektion |
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E.5 End points |
E.5.1 | Primary end point(s) |
The frequency of patients who report significant pain at rest (NRS > 3) |
Frekvensen af patienter som rapporterer betydende hvilesmerter (NRS > 3) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Pain scores are evaluated 8 times during the 2 hours observation period.
The observation period starts when the surgery is completed. This time is noted in the electronic patient file = t0
The test times are: At arrival at the Perioperative Section and at t = 30 min, t = 60 min t = 75 min, t = 90 min, t = 105 min, t = 120 min
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Smertescoring foretages 8 gange i løbet af den to timers observationsperiode.
Observationsperioden starter ved kirurgiafslutning. Dette tidspunkt er noteret i den elektroniske patientjournal = t0
Testtidspunkterne er: Ved ankomst til perioperativt afsnit og til t = 30 min, t = 60 min t = 75 min, t = 90 min, t = 105 min, t = 120 min |
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E.5.2 | Secondary end point(s) |
Sensory testing of the infrapatellar branch. The skin is tested in an area from the medial femoral condyle to the midline between the apex of patella and the tibial tuberosity.
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Sensorisk test af r. infrapatellaris. Huden testes i et område fra mediale femurkondyl til midtlinjen mellem apex patella og tuberosita tibia. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Sensory testing is conducted when the patient reports significant pain (NRS >3)
If the patient does not experience any pain during the observation period, sensory testing is conducted at the end of the observation period, t = 120 min |
Sensorisk test udføres når patienten rapporterer betydende smerter (NRS > 3)
Hvis patienten ikke oplever smerter i løbet af observationsperioden, udføres sensorisk test ved afslutning af observationsperioden, t = 120 min |
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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 | 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 | 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 | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |