Post-operative pain after laparoscopic colon or rectum surgery in fast-track design MedDRA version: 14.1 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Arcoxia 120mg
Product Name: Etoricoxib
Pharmaceutical Form: Capsule
INN or Proposed INN: ETORICOXIB
CAS Number: 0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentratio
Sponsors
Charité Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 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 ;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 | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: 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.;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.;Timepoint(s) of evaluation of this end point: third postoperative day | — |
Countries
Germany
Contacts
Public ContactUniv. - Prof. Dr. Claudia Spies
Charité Universitaetsmedizin Berlin
Outcome results
None listed