Met-Hb and inflammation markers with tumescence local anaesthesia (TLA)
| ISRCTN | ISRCTN19821978 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19821978 |
| Protocol serial number | anaesMA2007-02 |
| Sponsor | University Clinic Mannheim (Germany) - Department of Anaesthesiology and Critical Care Medicine |
| Funder | University Clinic Mannheim (Germany) - Department of Anaesthesiology and Critical Care Medicine |
- Submission date
- 12/12/2007
- Registration date
- 20/03/2008
- Last edited
- 20/03/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Grietje Beck
Scientific
Scientific
University Clinic Mannheim
Department of Anaesthesiology and Critical Care Medicine
Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany
| grietje.beck@anaes.ma.uni-heidelberg.de |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational study until 48 hours after surgery |
| Secondary study design | Cohort study |
| Scientific title | Met-Hb-concentration and inflammation markers in patients undergoing tumescence local anaesthesia (TLA) with supramaximal dosages of prilocaine |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | Tumescence local anaesthesia (TLA)/established anaesthesia techniques |
| Intervention | 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 |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Prilocaine |
| Primary outcome measure(s) |
Met-Hb-concentration over the time, measured over 48 hours. |
| Key secondary outcome measure(s) |
Elevation of inflammation markers, measured over 48 hours. |
| Completion date | 01/07/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Key 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 |
| Key exclusion criteria | 1. Allergy against prilocaine 2. Pregnancy 3. Patient denies operation in TLA |
| Date of first enrolment | 01/02/2008 |
| Date of final enrolment | 01/07/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
University Clinic Mannheim
Mannheim
68167
Germany
68167
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
