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

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.

Study Overview

• Status: Completed
• Conditions: Total Knee Replacement; Primary Knee Arthroplasty
• Intervention / Treatment: Drug: Fentanyl; Drug: Fentanyl; Drug: Ropivacaine

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Femoral Nerve Fentanyl; 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).	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: 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).
Active Comparator: Femoral Nerve Ropivacaine; 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).	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).
Placebo Comparator: Intravenous Fentanyl with placebo; 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).	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: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Postoperative Strength (Extension)	To assess extension force postoperatively to discern differences in muscle strength retention between continuous femoral nerve sheath catheter administration of fentanyl or Ropivacaine or a continuous IV infusion of fentanyl.	24 hours post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS Scores and Postoperative Supplemental Morphine Consumption	Secondary Objective; To determine the amount of required supplemental analgesia during the postoperative period.; To determine postoperative analgesia using a Visual Analog Scale (VAS) 0 - 10 centimeter line.	24 hours post-surgery
Serum Fentanyl Levels	To identify a difference in serum fentanyl levels among the groups.	24 hours post-surgery

Collaborators and Investigators

• Sponsor: University of South Florida
• Collaborators: Tampa General Hospital
• Investigators: Principal Investigator: Devanand Mangar, MD, Florida Gulf-to-Bay Anesthesiology Associates LLC

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• American Society of Anesthesiology

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: June 12, 2012
• First Submitted That Met QC Criteria: June 14, 2012
• First Posted (Estimate): June 15, 2012

Study Record Updates

• Last Update Posted (Estimate): November 11, 2013
• Last Update Submitted That Met QC Criteria: September 12, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Regional Anesthesia; Femoral Nerve Block; Total Knee Replacement; Post-operative pain management
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Ropivacaine
• Other Study ID Numbers: TGH-007 IRB # Pro00002055