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

University of South Florida

Status: Completed

Conditions: Primary Knee Arthroplasty; Total Knee Replacement

Treatments: Drug: Fentanyl; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01620047

TGH-007 IRB # Pro00002055

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

Femoral Nerve Fentanyl

Experimental group

Description:

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).

Treatment:

Drug: Fentanyl

Drug: Fentanyl

Femoral Nerve Ropivacaine

Active Comparator group

Description:

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).

Treatment:

Drug: Ropivacaine

Intravenous Fentanyl with placebo

Placebo Comparator group

Description:

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).

Treatment:

Drug: Fentanyl

Drug: Fentanyl