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Completed

NCT Number: NCT01620047

Postoperative Knee Strength Following Total Knee Replacement: A Double-Blinded Randomized Comparison Study

Major surgery involving the knee is often associated with severe postoperative pain. Postoperative pain control remains a significant contributor to delayed recovery and length of hospital stay. Approaches to minimize postoperative pain after surgery are a matter of major concern due to the need for early mobilization, a crucial factor in good postoperative rehabilitation. Femoral nerve blocks by either continuous infusion or single injection of anesthetics provide an effective method for analgesia while minimizing the need for systemic opioid therapy, reducing the opioid induced side effects, and facilitating early ambulation. Administration of fentanyl has shown to be a highly effective method to control pain after Total Knee Replacement (TKR). The investigators hypothesize that fentanyl infusions will result in greater post-operative strength in the operative knee.

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Key information

Conditions

Total Knee Replacement Primary Knee Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tampa General Hospital

Tampa, Florida, 33606, United States

About this study

All subjects scheduled to receive a unilateral, primary total knee replacement were evaluated for eligibility in the preoperative anesthesia center. Adults, older than 18 years of age, ASA I-III were included in the study. Subjects who were either pregnant, on anticoagulant therapy, allergic to opioids, local anesthetics, chronic pain patients, history of traumatic lower extremity injury, or had a body mass index of greater than 35 kg/m2 were excluded from the study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing unilateral primary total knee replacement
  • ASA class I-III
  • 18 years and older

Exclusion criteria

  • Patient refusal
  • Pregnancy
  • Coagulopathy
  • Adverse/allergic reaction to any opioids or local anesthetics
  • History of long-term opioid use (greater than 60 days)
  • Infection
  • Traumatic lower extremity injury

Treatment and study plan

Fentanyl

Drug

Fentanyl 3 µg/ml continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU)through a femoral nerve sheath catheter.

Ropivacaine

Drug

Ropivacaine 0.1% delivered through a femoral nerve sheath catheter continuously for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).

Primary outcomes

  1. Comparison of Postoperative Strength (Extension)

    Time frame: 24 hours post-surgery

    To assess extension force postoperatively to discern differences in muscle strength retention between continuous femoral nerve sheath catheter administration of fentanyl or Ropivacaine or a continuous IV infusion of fentanyl.

Secondary outcomes

  1. VAS Scores and Postoperative Supplemental Morphine Consumption

    Time frame: 24 hours post-surgery

    Secondary Objective

    • To determine the amount of required supplemental analgesia during the postoperative period.
    • To determine postoperative analgesia using a Visual Analog Scale (VAS) 0 - 10 centimeter line.

  2. Serum Fentanyl Levels

    Time frame: 24 hours post-surgery

    To identify a difference in serum fentanyl levels among the groups.

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

  • Tampa General Hospital

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 15, 2012
Registry last updated
Nov 11, 2013

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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