Condition category
Signs and Symptoms
Date applied
12/12/2007
Date assigned
20/03/2008
Last edited
20/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.klinikum-mannheim.de/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes