E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postoperative pain after reconstruction of the anterior cruciate ligament |
Postoperative smerter efter rekonstruktion af forreste korsbånd |
|
E.1.1.1 | Medical condition in easily understood language |
Pain after repair of the anterior cruciate ligament in the knee |
Smerter efter reparation af forreste korsbånd i knæet |
|
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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10078191 |
E.1.2 | Term | Anterior cruciate ligament reconstruction |
E.1.2 | System Organ Class | 100000021343 |
|
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 of this pilot study is to investigate the effect of the popliteal plexus block (PPB) as a supplement to femoral triangle block (FTB) after reconstruction of the anterior cruciate ligament. |
Formålet med dette pilotstudie er at undersøge effekten af plexus popliteus blokade (PPB) som supplement til trigonum femoralis blokade (FTB) efter rekonstruktion af forreste korsbånd |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives of the pilot study are: testing of the set-up for the following randomized clinical trial (RCT), length of observation periods, test methods, data collection for the power estimation for the RCT. |
Sekundære formål: afprøve set-up for det efterfølgende randomiserede, kontrollerede studie (RCT), længde på observationsperioder, testmetoder, indsamling af data til styrkeberegning til RCT. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients undergoing ACL reconstruction on one of the two trial sites - Age ≥ 18 - ASA I-III - Informed consent
|
- Patienter indstillet til ACL rekonstruktion på et af de to forsøgscentre - Alder ≥ 18 år - ASA I-III - Informeret samtykke
|
|
E.4 | Principal exclusion criteria |
- Patients unable to cooperate - Patients not able to speak Danish or with other communication problems - Pregnancy - Contraindication towards any medical product used in the study - Preoperatively reduced sensation on the medial and lateral part of the lower leg - Patients with diabetes requiring medical treatment - Preoperative intake of opioids (dosed > once daily) - ACL revision
|
- Manglende evne til at samarbejde - Manglende danskkundskaber eller andre former for kommunikationsproblemer - Graviditet - Allergi over for lægemidler som anvendes i undersøgelsen - Præoperativ nedsat sensorik sv.t. mediale og laterale crus - Patienter med behandlingskrævende diabetes - Patienter i præoperativt opioid behandling (doseret > 1 gang dagligt) - ACL revision
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The effect of the PPB evaluated as the percentage of patients with postoperative pain NRS >3 dropping in pain score to NRS ≤ 3 after the PPB
|
Effekten af PPB målt som andelen af patienter med postoperative smerter NRS >3, som efter anlæggelse af PPB falder til NRS ≤ 3. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Pain scores (NRS) are evaluated 15, 30, 45 and 60 minutes after the PPB. |
Smertescore (NRS) 15, 30, 45 og 60 minutter efter anlæggelse af PPB. |
|
E.5.2 | Secondary end point(s) |
1) The percentage of patients with FTB reporting pain (NRS >3) not localized to the graft donor site in the observation period 2) Onset time for PPB 3) The effect of the PPB on cutaneous sensation on the lateral part of the lower leg (pinprick test) 4) The effect of the PPB on muscle strength (dorsal flexion and plantar flexion in the ankle joint, measured with a handheld dynamometer)
|
1) Andelen af patienter med FTB, som i observationsperioden får smerter (NRS >3), som ikke er graft smerter 2) Anslagstid af PPB 3) Påvirkning af sensorik på laterale crus efter anlæggelse af PPB (pinprick test) 4) Påvirkning af muskelkraft efter PPB (dorsal fleksion og plantar fleksion i ankelleddet, målt med et håndholdt dynamometer)
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) Pain scores: 15, 30, 45 and 60 minutes after t0 (t0 = arrival at the PACU) 2) Time from withdrawal of the needle until patient reports NRS ≤ 3) 3) Sensory test: Baseline, 30 and 60 minutes after PPB 4) Muscle strength: Baseline, 60 minutes after PPB
|
1) Smertescore (NRS): 15, 30, 45 og 60 minutter efter t0 (t0 = ankomst til PACU) 2) Tiden fra udtrækning af blokadenål og til patienten angiver NRS ≤ 3 3) Sensorisk test: baseline, 30 og 60 minutter efter anlæggelse af PPB 4) Muskelkraft: baseline, 60 minutter efter anlæggelse af PPB
|
|
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 | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Pilot study. Testing of the set-up, length of observation period and tests methods and collection of data for the power estimation. |
Pilotstudie. Afprøvning af set-up, længde af observationsperioder og testmetoder, indsamling af data til styrkeberegningen.
|
|
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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
|
|
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 | 8 |
E.8.9.1 | In the Member State concerned days | 0 |