Clinical trial NCT01620047: Postoperative Knee Strength Following Total Knee Replacement: A Double-Blinded Randomized Comparison Study
Official title: Postoperative Knee Strength Following Total Knee Replacement: A Double-Blinded Randomized Comparison Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Replacement
Primary Knee Arthroplasty
Keywords: Regional Anesthesia
Post-operative pain management
Femoral Nerve Block
Total Knee Replacement
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Tampa General Hospital
First posted: 2012-06-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Comparison of Postoperative Strength (Extension)
timeFrame: 24 hours post-surgery
Secondary outcomes:
measure: VAS Scores and Postoperative Supplemental Morphine Consumption
timeFrame: 24 hours post-surgery
measure: Serum Fentanyl Levels
timeFrame: 24 hours post-surgery
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
Study officials:
affiliation: Florida Gulf-to-Bay Anesthesiology Associates LLC
name: Devanand Mangar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Charous MT, Madison SJ, Suresh PJ, Sandhu NS, Loland VJ, Mariano ER, Donohue MC, Dutton PH, Ferguson EJ, Ilfeld BM. Continuous femoral nerve blocks: varying local anesthetic delivery method (bolus versus basal) to minimize quadriceps motor block while maintaining sensory block. Anesthesiology. 2011 Oct;115(4):774-81. doi: 10.1097/ALN.0b013e3182124dc6.
citation: Bauer M, Wang L, Onibonoje OK, Parrett C, Sessler DI, Mounir-Soliman L, Zaky S, Krebs V, Buller LT, Donohue MC, Stevens-Lapsley JE, Ilfeld BM. Continuous femoral nerve blocks: decreasing local anesthetic concentration to minimize quadriceps femoris weakness. Anesthesiology. 2012 Mar;116(3):665-72. doi: 10.1097/ALN.0b013e3182475c35.