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

Total Knee Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01620047
• Other study ID #: TGH-007 IRB # Pro00002055
• Status: Completed
• Phase: N/A
• First received: June 12, 2012
• Last updated: September 12, 2013
• Start date: March 2011
• Est. completion date: March 2012

Study information

• Verified date: September 2013
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Primary Knee Arthroplasty
• Total Knee Replacement

Intervention

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.
• 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).
• 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).

Locations

Country	Name	City	State
United States	Tampa General Hospital	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	Tampa General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Serum Fentanyl Levels	To identify a difference in serum fentanyl levels among the groups.	24 hours post-surgery	No

External Links

•   American Society of Anesthesiology