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Completed

NCT Number: NCT01631799

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

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) ?

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Key information

Conditions

Morbidity Complications Function Mortality

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rostock

Rostock, Mecklenburg-Vorpommern, 18057, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • obesity
  • contraindication for epidural anesthesia
  • coagulation disorders

Treatment and study plan

Femoral catheter

Device

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

Device

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.

Primary outcomes

  1. Function

    Time frame: 3 months after surgery

    3 months after surgery the function of the total knee replacement is testd

Secondary outcomes

  1. Mortality

    Time frame: 28 days after surgery

  2. Morbidity

    Time frame: 28 days after surgery

Sponsors and collaborators

Lead sponsor

University of Rostock

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jun 29, 2012
Registry last updated
Jun 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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