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15 May 2008
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| [ Print-friendly version ] |
| Met-Hb and inflammation markers with tumescence local anaesthesia (TLA) |
| ISRCTN | ISRCTN19821978 |
| ClinicalTrials.gov identifier | |
| Public title | Met-Hb and inflammation markers with tumescence local anaesthesia (TLA) |
| Scientific title | Met-Hb-concentration and inflammation markers in patients undergoing tumescence local anaesthesia (TLA) with supramaximal dosages of prilocaine |
| Acronym | N/A |
| Serial number at source | anaesMA2007-02 |
| Study hypothesis |
Tumescence local anaesthesia (TLA) is an established anaesthesia technique, where large amounts of highly diluted local anaesthetics are used. Due to its low toxicity, prilocaine is used frequently. Though, prilocaine can - dosage-dependant - cause a methemoglobinaemia, leading to a reduced oxygen transport capacity. Furthermore, certain processes of the inflammation cascade are initiated. These effects are important for ambulatory patients and the following healing process.
The aim of the study is to evaluate the Met-Hb concentration and inflammation markers like interleukin-1 (IL-1), interleukin-6 (IL-6) and interleukin-8 (IL-8), tumour necrotising factor (TNF), C-reactive protein (CRP) in a chronological sequence. Hypothesis: TLA in supramaximal dosages of prilocaine has an influence on plasmatic inflammation markers, which will elevate in the first 48 hours. Furthermore, the Met-Hb production will not be finished within this time. |
| Ethics approval | Ethics approval received from the local medical ethics committee (Medizinische Ethik-Komission II: Medizinische Fakultat Mannheim der Ruprechts-Karls-Universitat Heidelberg) on the 22nd November 2007 (ref: 2007-258N-MA) |
| Study design | Observational study until 48 hours after surgery |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Tumescence local anaesthesia (TLA)/established anaesthesia techniques |
| Participants - inclusion criteria |
1. Patients (male/female) with operations which are performed in TLA with prilocaine
2. Age: 18 - 85 years 3. American Society of Anaesthesiologists (ASA) grade I - III 4. No allergy against prilocaine |
| Participants - exclusion criteria |
1. Allergy against prilocaine
2. Pregnancy 3. Patient denies operation in TLA |
| Anticipated start date | 01/02/2008 |
| Anticipated end date | 01/07/2009 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | 40 |
| Interventions |
As a standard procedure in our clinic, patients with dermatological operations will receive a TLA with more than 600 mg prilocaine. Seven blood samples (approximately 8 ml) will be taken 0, 1, 2, 4, 12, 24 and 48 hours after TLA, where the following parameters will be determined from:
1. Demographic data and vital parameters 2. Met-Hb-concentration 3. Prilocaine-concentration 4. IL-1 5. IL-6 6. IL-8 7. TNF-alpha 8. CRP 9. Procalcitonin (PCT) 10. Creatine kinase (CK) 11. Lactate dehydrogenase (LDH) 12. Reticulocytes 13. Myoglobin 14. Haptoglobin 15. Complications |
| Primary outcome measure(s) | Met-Hb-concentration over the time, measured over 48 hours. |
| Secondary outcome measure(s) | Elevation of inflammation markers, measured over 48 hours. |
| Sources of funding | University Clinic Mannheim (Germany) - Department of Anaesthesiology and Critical Care Medicine |
| Trial website | |
| Publications | |
| Contact name | Prof Grietje Beck |
| Address |
University Clinic Mannheim
Department of Anaesthesiology and Critical Care Medicine Theodor-Kutzer-Ufer 1-3 |
| City/town | Mannheim |
| Zip/Postcode | 68167 |
| Country | Germany |
| grietje.beck@anaes.ma.uni-heidelberg.de | |
| Sponsor | University Clinic Mannheim (Germany) - Department of Anaesthesiology and Critical Care Medicine |
| Address | Theodor-Kutzer-Ufer 1-3 |
| City/town | Mannheim |
| Zip/Postcode | 68167 |
| Country | Germany |
| marc.schmittner@anaes.ma.uni.heidelberg.de | |
| Sponsor website: | http://www.klinikum-mannheim.de/ |
| Date applied | 12/12/2007 |
| Last edited | 20/03/2008 |
| Date ISRCTN assigned | 20/03/2008 |
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