E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postoperative pain after hernia inguinalis repair surgery |
postoperatieve pijn na liesbreukcorrectie |
|
E.1.1.1 | Medical condition in easily understood language |
postoperative pain after hernia inguinalis repair |
postoperatieve pijn na operatieve liesbreukcorrectie |
|
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 | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036236 |
E.1.2 | Term | Postoperative pain relief |
E.1.2 | System Organ Class | 100000004865 |
|
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 |
Primary objective is to analyse, differences in pain scores between the 2 groups until 48 hours after the operation. |
Analyseren of ertot 48 uur postoperatief verschillende pijnscores gemeten worden in de twee studiegroepen |
|
E.2.2 | Secondary objectives of the trial |
Time to the first use of intravenous Morfine, the total amount of titrated postoperative Morfine, use of Tramadol at
home, patient satisfaction en the incidence of nausea and vomiting. |
Tijdstip 1e toediening morfine, totale hoeveelheid toegediende morfine, het Tramadol gebruik in de thuissituatie, misselijkheid en braken, patiënttevredenheid |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
age between 18-80, competent, elective surgical treatment, Body Mass Index (BMI) between 20-35 |
leeftijd tussen 18 en 80 jaar
wilsbekwaam
electieve ingreep
BMI tussen de 20 en 35 |
|
E.4 | Principal exclusion criteria |
fever, a coagulation disorder, patiënts with kidney and or liver faillure, an infection at the place by the puncture place, preoperative use of narcotics and NSAID's |
koorts
stollingstoornissen
patiënten met nier- en leverinsufficiëntie
wondinfecties bij de insteekplaats
preoperatief gebruik opiaten en NSAID's |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary objective is to analyse, differences in pain scores between the 2 groups until 48 hours after the operation. |
Primair eindpunt is het analyseren van de verschillen tussen de 2 groepen in pijnscores tot 48 uur na de operatie |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 30 patients |
na 30 patiënten |
|
E.5.2 | Secondary end point(s) |
Secondary objectives are; time to to first use of intravenous Morfine, the total amount of titrated postoperative Morfine, use of Tramadol at
home, patient satisfaction en the incidence of nausea and vomiting. |
Secundaire eindpunten zijn: tijdstip van de eerste intraveneuse morfine toediening, de totaal getitreerd postoperatief morfinegebruik, Tramadolgebruik thuis, patiënttevredenheid en misselijkheid en braken |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
After 30 patients |
na 30 patiënten |
|
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 | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
|
48 hours postoperative, after the patiënts answered the last questionaire |
48 uur na de operatie als de laatste patiënt gevraagd is naar zijn/haar
pijnklachten is de studie voor de beeïndigd |
|
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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |