Contact information
Type
Scientific
Primary contact
Dr Thomas Volk
ORCID ID
Contact details
Charité Universitätsmedizin Berlin
Department of Anesthesiology and Intensive Care Medicine
Charitéplatz 1
Berlin
10098
Germany
+49 (030) 450 531012
anaesth@charite.de
Additional identifiers
EudraCT number
2005-000237-37
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
FemoX
Study hypothesis
Patients with a catheter-based analgesia at the femoral nerve have less pain compared to patients receiving a Patient-Controlled Analgesia (PCA).
Ethics approval
Ethics approval received, no details provided as of 29/01/2007.
Study design
Single-blinded, randomised study.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Ruptured anterior cruciate ligament
Intervention
Peripheral nerve catheter at the femoral nerve versus PCA.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Pain levels.
Secondary outcome measures
Physiotherapeutic options.
Overall trial start date
01/01/2006
Overall trial end date
31/12/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Patients receiving a anterior cruciate ligament repair.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
90
Participant exclusion criteria
1. Pregnancy
2. Redo-Surgery
3. Neurologic or psychiatric diseases
4. Other diseases potentially putting the patient at risk
5. Body Mass Index of more than 35
6. Allergic to local anesthetics
Recruitment start date
01/01/2006
Recruitment end date
31/12/2006
Locations
Countries of recruitment
Germany
Trial participating centre
Charité Universitätsmedizin Berlin
Berlin
10098
Germany
Sponsor information
Organisation
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Sponsor details
c/o PD Dr Thomas Volk
Department of Anesthesiology and Intensive Care Medicine
Charitéplatz 1
Berlin
10098
Germany
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin), Medical School Research Grant (Germany)
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