Condition category
Musculoskeletal Diseases
Date applied
11/08/2006
Date assigned
29/01/2007
Last edited
06/02/2008
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

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

http://www.charite.de/ch/anaest/

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

Publication citations

Additional files

Editorial Notes