Influence of continuous femoral analgesia after anterior cruciate ligament repair on postoperative pain and range of motion: a pilot study
| ISRCTN | ISRCTN85092388 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85092388 |
| Clinical Trials Information System (CTIS) | 2005-000237-37 |
| Protocol serial number | N/A |
| Sponsor | Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany) |
| Funder | Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin), Medical School Research Grant (Germany) |
- Submission date
- 11/08/2006
- Registration date
- 29/01/2007
- Last edited
- 06/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
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
Dr Thomas Volk
Scientific
Scientific
Charité Universitätsmedizin Berlin
Department of Anesthesiology and Intensive Care Medicine
Charitéplatz 1
Berlin
10098
Germany
| Phone | +49 (030) 450 531012 |
|---|---|
| anaesth@charite.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-blinded, randomised study. |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | FemoX |
| Study objectives | Patients with a catheter-based analgesia at the femoral nerve have less pain compared to patients receiving a Patient-Controlled Analgesia (PCA). |
| Ethics approval(s) | Ethics approval received, no details provided as of 29/01/2007. |
| Health condition(s) or problem(s) studied | Ruptured anterior cruciate ligament |
| Intervention | Peripheral nerve catheter at the femoral nerve versus PCA. |
| Intervention type | Other |
| Primary outcome measure(s) | Pain levels. |
| Key secondary outcome measure(s) | Physiotherapeutic options. |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 90 |
| Key inclusion criteria | Patients receiving a anterior cruciate ligament repair. |
| Key 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 |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Germany
Study participating centre
Charité Universitätsmedizin Berlin
Berlin
10098
Germany
10098
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
