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N/A N=60 Randomized Quadruple-blind Treatment

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

Total Knee Replacement · Primary Knee Arthroplasty

Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcome: Primary: Comparison of Postoperative Strength (Extension) — .08; .03; .05 Nm/kg

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Fentanyl (Drug); Ropivacaine (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of South Florida
Primary completion
Jan 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Comparison of Postoperative Strength (Extension)
.08; .03; .05
SECONDARY
VAS Scores and Postoperative Supplemental Morphine Consumption
SECONDARY
Serum Fentanyl Levels

Summary

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01620047). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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