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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas Mencke, University of Rostock
ClinicalTrials.gov Identifier:
NCT01631799
First received: June 27, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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 Intervention
Morbidity
Mortality
Complications
Function
Device: Femoral catheter
Device: Epidural catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by University of Rostock:

Primary Outcome Measures:
  • Function [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
    3 months after surgery the function of the total knee replacement is testd


Secondary Outcome Measures:
  • Mortality [ Time Frame: 28 days after surgery ] [ Designated as safety issue: No ]
  • Morbidity [ Time Frame: 28 days after surgery ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: October 2008
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 27, 2012
Last Updated: June 27, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014