E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postoperative pain following laparoscopic surgery due to acute appendicitis |
Postoperative smerter efter laparoskopisk kirurgi for akut appendicits |
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E.1.1.1 | Medical condition in easily understood language |
Pain following minimal invasive surgery due to acute appendicitis |
Smerter efter kikkertkirurgi på grund af akut blindtarmsbetændelse |
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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 | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000677 |
E.1.2 | Term | Acute appendicitis |
E.1.2 | System Organ Class | 100000004862 |
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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 explore weather the use of the BD-TAP abdominal wall blockade for patients undergoing laparoscopic surgery due to acute appendicits can anesthetize the patients and therefore reduce the patient's postoperative pain and thus reduce their postoperative morphine consumption. The main objective is pain score in motion, from lying flat in bed to sitting up, assessed 0-12 hours postoperatively using the nummerical rating scale (NRS) 0-10. |
At undersøge om anlæggelse af BD-TAP blokaden til patienter der skal opereres med laparoskopisk kirurgi for akut appendicits kan smertedække patienter, så der opleves en reduktion i postoperative smerter og dermed en reduktion i behovet for morfin. Det primære effektparameter er smertescore fra liggende fladt i sengen til siddende stilling målt med nummerical rating scale (NRS) 0-10 0-12 timer postoperativt. |
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E.2.2 | Secondary objectives of the trial |
Pain score at rest assessed with NRS 0-10, 0-12 hours postoperatively Total postoperative morphine consumption Time to first mobilisation Lenght of stay in postanesthesia care unit (PACU) Side effects to morphine consumption |
Smertescore i hvile, målt med NRS 0-10, 0-12 timer postoperativt Total postoperativt morfinforbrug Tid til første mobilisering Tid i opvågningsafsnittet Bivirkninger til morfin
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age above 18 Patients undergoing laparoscopic surgery for acute appendicits American Society of Anaesthesiology group 1-3 General anaesthesia |
Alder over 18 år Patienter indstillet til diagnostisk laparoskopi obs. akut appendicitis American Society of Anaesthesiology gruppe 1-3 Generel anæstesi |
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E.4 | Principal exclusion criteria |
Inability to cooperate Inability to talk and understand danish Allergic to ropivacaine Drug and alcohol abuse Pregnancy and nursing |
Patienter der ikke kan samarbejde til proceduren Kan ikke tale eller forstå danske Allergi overfor ropivacaine Alkohol og medicin misbrug Graviditet og amning |
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E.5 End points |
E.5.1 | Primary end point(s) |
A reduction in pain score assessed on the nummerical rating scare (NRS) 0-10 of a minimum of 2 compared with the pain score of the placebo group |
En reduktion i smertescore målt med NRS 0-10 på minimum 2 sammenlignet med placebogruppens smertescore. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Pain score from lying flat in bed to sitting up in bed assessed 0h, 1/2h, 1h, 2h, 3h, 4h, 5h, 6h and 12 hours postoperatively |
Smertescoren fra liggende fladt i sengen til siddende stilling registreres 0, 1/2, 1, 2, 3, 4, 5, 6 og 12 timer postoperativt. |
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E.5.2 | Secondary end point(s) |
Pain score at rest assessed with NRS 0-10, 0-12 hours postoperatively Total postoperative morphine consumption Time to first mobilisation Lenght of stay in postanesthesia care unit (PACU) Side effects to morphine consumption |
Smertescore i hvile, målt med NRS 0-10, 0-12 timer postoperativt Total postoperativt morfinforbrug Tid til første mobilisering Tid i opvågningsafsnittet Bivirkninger til morfin
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Pain score assessed at rest using NRS 0-10 at 0h, 1/2h, 1h, 2h, 3h, 4h, 5h, 6h and 12 hours postoperatively Morphine consumption 0-12 hours postoperatively Minutes of stay in PACU Nausea and/or vomiting 0-12 hours postoperatively registred at 0h, 1/2h, 1h, 2h, 3h, 4h, 5h, 6h and 12 hours postoperatively
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Smertescoren i hvile registreres 0, 1/2, 1, 2, 3, 4, 5, 6 og 12 timer postoperativt. Total morfinforbrug 0-12 timer postoperativt Antal minutter i opvågningsafsnittet Kvalme og/eller opkastninger 0-12 timer postoperativt registreres 0, 1/2, 1, 2, 3, 4, 5, 6 og 12 timer postoperativt. |
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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 | Yes |
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
|
LVLS |
Når alle 56 evaluérbare patienter er inkluderet |
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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 | |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | |