Outcome of Patients After Total Knee Replacement: A Comparison of Femoral Nerve Block and Epidural Anesthesia

Mortality Clinical Trial

Official title:

Outcome of Patients After Total Knee Replacement: A Comparison of Femoral Nerve Block and Epidural Anesthesia. A Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01631799
• Other study ID #: A 40 2008
• Status: Completed
• Phase: N/A
• First received: June 27, 2012
• Last updated: June 27, 2012
• Start date: October 2008
• Est. completion date: December 2011

Study information

• Verified date: June 2012
• Source: University of Rostock
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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) ?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• age 18 -80 years

• ASA I-III

• Surgery: total knee replacement

• informed consent

Exclusion Criteria:

• obesity

• contraindication for epidural anesthesia

• coagulation disorders

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complications
• Function
• Morbidity
• Mortality

Intervention

Device:
• Femoral catheter
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.
• Epidural catheter
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.

Locations

Country	Name	City	State
Germany	University of Rostock	Rostock	Mecklenburg/Vorpommern

Sponsors (1)

Lead Sponsor	Collaborator
University of Rostock

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Function	3 months after surgery the function of the total knee replacement is testd	3 months after surgery	No
Secondary	Mortality		28 days after surgery	No
Secondary	Morbidity		28 days after surgery	No