E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Post-operative pain after laparoscopic colon or rectum surgery in fast-track design |
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E.1.1.1 | Medical condition in easily understood language |
Post-operative pain after colon or rectum surgery |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
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 |
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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 demonstrate that the administration of etoricoxib 120mg additionally to the clinical routine therapy (epidural catheter) reduces the post-operative pain level during movement at the thrid day after laparoscopic colon or rectum surgery in the fast-track design. |
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E.2.2 | Secondary objectives of the trial |
To demonstrate that the administration of etoricoxib 120mg additionally to the clinical routine therapy (epidural catheter):
1. reduces the post-operative pain level during movement in the first 2 days after laparoscopic colon or rectum surgery in the fast-track design.
2. reduces the post-operative pain level during rest in the first 2 days after laparoscopic colon or rectum surgery in the fast-track design.
3. reduces the post-operative pain level during rest and movement from the third until the fifth day after laparoscopic colon or rectum surgery (one day after epidural catheter removal)
4. reduces the incidence of pain events and the average pain intensity in body parts outside of the area of operations.
5. reduces the incidence of new organ dysfuntions, side effects, frequency and amount of intake of rescue medication
6. reduces postoperative LOS
7. increases the patients level of satisfaction. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- age >= 18 years
- written informed consent
- no inclusion in other medical studies according to the AMG (German drug law) during the study period
- realization of planned colon or rectum surgery in the fast track design after clinical standards including an epidural catheter |
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E.4 | Principal exclusion criteria |
- ASA status IV-V
- allergy against etoricoxib, other components or other NSAID
- coronary heart disease
- heart insufficiency NYHA II-IV
- cerebrovascular disease
- peripheral arterial occlusive disease
- untreated arterial hypertonus
- active peptic ulcera or active gastrointestinal bleeding
- light to severe liver dysfunction (beginning from Child - Plugh - Classification A)
- kidney insufficiency
- inflammatory bowl disease
- pregnancy or lactation
- placement in an institution on order of an official authority
- missing consent for saving and passing on pseudonymous data
- hereditary galactose-intolerance, lactase deficit, glucose-galactose-malabsorption
- no correct epidural catheter placement within 48 h after surgery
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary end point of the study is the average pain level (scale 0-10) in the area of surgery during movement (walking a fixed number of steps) under active epidural analgesia, at the third day following laparoscopic colon or rectum surgery. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. Post-operative pain level during movement in the first 2 days after laparoscopic colon or rectum surgery.
2. Post-operative pain level during rest in the first 2 days after laparoscopic colon or rectum surgery.
3. Post-operative pain level during rest and movement from the third until the fifth day after laparoscopic colon or rectum surgery (one day after epidural catheter removal)
4. Incidence of pain events and the average pain intensity in body parts outside of the area of operations.
5. Incidence of new organ dysfunctions, side effects, frequency and amount of intake of rescue medication.
6. Postoperative LOS/ postoperative ICU stay
7. Patients level of satisfaction |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. In the first 2 days after laparoscopic colon or rectum surgery
2. In the first 2 days after laparoscopic colon or rectum surgery
3. One day after epidural catheter removal
4. and 5. study period
6. period of hospital stay/ICU stay
7. study period
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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
| 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 | 4 |
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
|
Hospital discharge of the last patient. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |