N/A Completed 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

Source: ClinicalTrials.gov NCT01620047 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2013

Primary outcomePrimary: Comparison of Postoperative Strength (Extension) — .08; .03; .05 Nm/kg

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.

Outcome Measures

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

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. Informational only — not medical advice.