We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01631799
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : June 29, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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) ?

Condition or disease Intervention/treatment
Morbidity Mortality Complications Function Device: Femoral catheter Device: Epidural catheter

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Outcome of Patients After Total Knee Replacement: A Comparison of Femoral Nerve Block and Epidural Anesthesia. A Randomized, Controlled Trial
Study Start Date : October 2008
Primary Completion Date : September 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Femoral Block
One group received a femoral block for analgesia after surgery. Ropivacain was administered continuously for three days.
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.
Active Comparator: Epidural Analgesia
One group received an epidural analgesia after surgery for three days.
Device: 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.


Outcome Measures

Primary Outcome Measures :
  1. Function [ Time Frame: 3 months after surgery ]
    3 months after surgery the function of the total knee replacement is testd


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 28 days after surgery ]
  2. Morbidity [ Time Frame: 28 days after surgery ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18 -80 years
  • ASA I-III
  • Surgery: total knee replacement
  • informed consent

Exclusion Criteria:

  • obesity
  • contraindication for epidural anesthesia
  • coagulation disorders
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631799


Locations
Germany
University of Rostock
Rostock, Mecklenburg/Vorpommern, Germany, 18057
Sponsors and Collaborators
University of Rostock
Investigators
Principal Investigator: Thomas Mencke, PD Dr. Dep. of Anesthesia, University of Rostock
More Information

Responsible Party: Thomas Mencke, PD Dr. Thomas Mencke, University of Rostock
ClinicalTrials.gov Identifier: NCT01631799     History of Changes
Other Study ID Numbers: A 40 2008
First Posted: June 29, 2012    Key Record Dates
Last Update Posted: June 29, 2012
Last Verified: June 2012

Keywords provided by Thomas Mencke, University of Rostock:
epidural anesthesia
femoral block
patient control analgesia

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs