Met-Hb and inflammation markers with tumescence local anaesthesia (TLA)

ISRCTN ISRCTN19821978
DOI https://doi.org/10.1186/ISRCTN19821978
Secondary identifying numbers anaesMA2007-02
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

University Clinic Mannheim
Department of Anaesthesiology and Critical Care Medicine
Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany

Email grietje.beck@anaes.ma.uni-heidelberg.de

Study information

Study designObservational study until 48 hours after surgery
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeDiagnostic
Scientific titleMet-Hb-concentration and inflammation markers in patients undergoing tumescence local anaesthesia (TLA) with supramaximal dosages of prilocaine
Study objectivesTumescence 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) studiedTumescence local anaesthesia (TLA)/established anaesthesia techniques
InterventionAs 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Prilocaine
Primary outcome measureMet-Hb-concentration over the time, measured over 48 hours.
Secondary outcome measuresElevation of inflammation markers, measured over 48 hours.
Overall study start date01/02/2008
Completion date01/07/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants40
Key inclusion criteria1. 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 criteria1. Allergy against prilocaine
2. Pregnancy
3. Patient denies operation in TLA
Date of first enrolment01/02/2008
Date of final enrolment01/07/2009

Locations

Countries of recruitment

  • Germany

Study participating centre

University Clinic Mannheim
Mannheim
68167
Germany

Sponsor information

University Clinic Mannheim (Germany) - Department of Anaesthesiology and Critical Care Medicine
Hospital/treatment centre

Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany

Email marc.schmittner@anaes.ma.uni.heidelberg.de
Website http://www.klinikum-mannheim.de/
ROR logo "ROR" https://ror.org/05sxbyd35

Funders

Funder type

Hospital/treatment centre

University Clinic Mannheim (Germany) - Department of Anaesthesiology and Critical Care Medicine

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan