Contact information
Type
Scientific
Primary contact
Prof Grietje Beck
ORCID ID
Contact details
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
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
anaesMA2007-02
Study information
Scientific title
Met-Hb-concentration and inflammation markers in patients undergoing tumescence local anaesthesia (TLA) with supramaximal dosages of prilocaine
Acronym
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
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
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 names
Prilocaine
Primary outcome measure
Met-Hb-concentration over the time, measured over 48 hours.
Secondary outcome measures
Elevation of inflammation markers, measured over 48 hours.
Overall trial start date
01/02/2008
Overall trial end date
01/07/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Allergy against prilocaine
2. Pregnancy
3. Patient denies operation in TLA
Recruitment start date
01/02/2008
Recruitment end date
01/07/2009
Locations
Countries of recruitment
Germany
Trial participating centre
University Clinic Mannheim
Mannheim
68167
Germany
Sponsor information
Organisation
University Clinic Mannheim (Germany) - Department of Anaesthesiology and Critical Care Medicine
Sponsor details
Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany
marc.schmittner@anaes.ma.uni.heidelberg.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Clinic Mannheim (Germany) - Department of Anaesthesiology and Critical Care Medicine
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list