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

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

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) ?

Study Overview

• Status: Completed
• Conditions: Mortality; Complications; Morbidity; Function
• Intervention / Treatment: Device: Femoral catheter; Device: Epidural catheter

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Mecklenburg/Vorpommern
    • Rostock, Mecklenburg/Vorpommern, Germany, 18057
      • University of Rostock

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Function	3 months after surgery the function of the total knee replacement is testd	3 months after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality	28 days after surgery
Morbidity	28 days after surgery

Collaborators and Investigators

• Sponsor: University of Rostock
• Investigators: Principal Investigator: Thomas Mencke, PD Dr., Dep. of Anesthesia, University of Rostock

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: June 27, 2012
• First Submitted That Met QC Criteria: June 27, 2012
• First Posted (ESTIMATE): June 29, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): June 29, 2012
• Last Update Submitted That Met QC Criteria: June 27, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: femoral block; epidural anesthesia; patient control analgesia
• Other Study ID Numbers: A 40 2008