Outcome of Patients After Total Knee Replacement: A Comparison of Femoral Nerve Block and Epidural Anesthesia
1 other identifier
interventional
80
1 country
1
Brief Summary
Total knee replacement is very common in Germany. After surgery patients have severe pain in the knee; initiation of the physiotherapy, however, is important in the first three days after surgery. Continuous femoral blockade and continuous (lumbar) epidural analgesia are commonly used after surgery. Both methods are used in Germany. Both methods have advantages and disadvantages. We wanted to answer the question which method of analgesia - after total knee replacement - is better concerning complications and function (after 3 months) ?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 27, 2012
CompletedFirst Posted
Study publicly available on registry
June 29, 2012
CompletedJune 29, 2012
June 1, 2012
2.9 years
June 27, 2012
June 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Function
3 months after surgery the function of the total knee replacement is testd
3 months after surgery
Secondary Outcomes (2)
Mortality
28 days after surgery
Morbidity
28 days after surgery
Study Arms (2)
Femoral Block
ACTIVE COMPARATOROne group received a femoral block for analgesia after surgery. Ropivacain was administered continuously for three days.
Epidural Analgesia
ACTIVE COMPARATOROne group received an epidural analgesia after surgery for three days.
Interventions
Femoral catheter was inserted at the beginning of surgery. After surgery ropivacaine was administered continuously for three days. In addition, patients received piritramide via patient-controlled analgesia. The amount of ropivacaine was measured.
The epidural catheter was inserted at the beiginning of surgery. After surgery ropivacaine was applied continuously for three days. In addition, patients received piritramide via patient controlled analgesia. The amount of ropivacaine was measured.
Eligibility Criteria
You may qualify if:
- age 18 -80 years
- ASA I-III
- Surgery: total knee replacement
- informed consent
You may not qualify if:
- obesity
- contraindication for epidural anesthesia
- coagulation disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Rostock
Rostock, Mecklenburg-Vorpommern, 18057, Germany
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Mencke, PD Dr.
Dep. of Anesthesia, University of Rostock
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PD Dr. Thomas Mencke
Study Record Dates
First Submitted
June 27, 2012
First Posted
June 29, 2012
Study Start
October 1, 2008
Primary Completion
September 1, 2011
Study Completion
December 1, 2011
Last Updated
June 29, 2012
Record last verified: 2012-06