NCT01620047

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of South Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Total Knee Replacement
• Primary Knee Arthroplasty

Interventions

Type	Name	Description
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.
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).
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).

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-01-01
• Completion: 2012-03-01
• First posted: 2012-06-15
• Last updated: 2013-11-11
• Results posted: 2013-11-11

Locations

1 site across 1 country: United States