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

This study has been completed.
Sponsor:
Collaborator:
Tampa General Hospital
Information provided by (Responsible Party):
Enrico Camporesi, University of South Florida
ClinicalTrials.gov Identifier:
NCT01620047
First received: June 12, 2012
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Total Knee Replacement
Primary Knee Arthroplasty
Drug: Fentanyl
Drug: Ropivacaine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Knee Strength Following Total Knee Replacement: A Double-Blinded Randomized Comparison Study

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Comparison of Postoperative Strength (Extension) [ Time Frame: 24 hours post-surgery ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • VAS Scores and Postoperative Supplemental Morphine Consumption [ Time Frame: 24 hours post-surgery ] [ Designated as safety issue: No ]

    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.

  • Serum Fentanyl Levels [ Time Frame: 24 hours post-surgery ] [ Designated as safety issue: No ]
    To identify a difference in serum fentanyl levels among the groups.


Enrollment: 60
Study Start Date: March 2011
Study Completion Date: March 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Femoral Nerve Fentanyl
Fentanyl 3 µg/ml delivered continuously through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were 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).
Drug: Fentanyl
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.
Active Comparator: Femoral Nerve Ropivacaine
Ropivacaine 0.1% continuously delivered through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were 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).
Drug: Ropivacaine
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).
Placebo Comparator: Intravenous Fentanyl with placebo
Control group which received 0.9% normal saline delivered through a femoral nerve sheath catheter in addition to a continuous intravenous infusion of fentanyl 3 µg/ml via a PCA pump. All study drugs were 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).
Drug: Fentanyl
0.9% normal saline delivered through a femoral nerve sheath catheter in addition to a continuous intravenous infusion of fentanyl 3 µg/ml via a PCA pump 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).

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01620047

Locations
United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33606
Sponsors and Collaborators
University of South Florida
Tampa General Hospital
Investigators
Principal Investigator: Devanand Mangar, MD Florida Gulf-to-Bay Anesthesiology Associates LLC
  More Information

Additional Information:
Publications:
Responsible Party: Enrico Camporesi, President, University of South Florida
ClinicalTrials.gov Identifier: NCT01620047     History of Changes
Other Study ID Numbers: TGH-007 IRB # Pro00002055
Study First Received: June 12, 2012
Results First Received: May 23, 2013
Last Updated: September 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
Regional Anesthesia
Post-operative pain management
Femoral Nerve Block
Total Knee Replacement

Additional relevant MeSH terms:
Anesthetics
Fentanyl
Ropivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Anesthetics, Local

ClinicalTrials.gov processed this record on April 17, 2014