Exparel vs Exparel Plus ACB in TKAs

Knee Osteoarthritis Clinical Trial

Official title:

Two-arm, Double-blind Randomized Study Comparing Exparel and Exparel Plus an Adductor Canal Block in Total Knee Arthroplasty

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02365727
• Other study ID #: Pro00034356
• Status: Withdrawn
• Phase: Phase 4
• First received: February 11, 2015
• Last updated: January 13, 2016
• Start date: April 2015
• Est. completion date: August 2015

Study information

• Verified date: January 2016
• Source: The Hawkins Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Patients will be randomized (like the flip of a coin) to receive Exparel and a nerve block, standard of care for this procedure, or Exparel alone for pain management after surgery. They will also be asked to complete questionnaires before surgery, during their stay at the hospital after surgery, then at 3 months, 6 months and 12 months after surgery to assess pain and/or function levels, as well as the amount of pain medicine patients have used after surgery. Patients' leg strength will be measured immediately after surgery and again at 3, 6 and 12 months after surgery.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Male or female, aged 18 to 80 years at the time of surgery.

• Willing and able to give voluntary informed consent to participate in this investigation.

• Candidate for total knee arthroplasty.

• BMI < 35.

Exclusion Criteria:

• Subject has had previous arthroplasty or fracture procedure(s) on the operative knee.

• Creatine level = 1.5

• Pre-existing gait disturbance or neuropathy.

• Allergy to local anesthetics.

• Inflammatory arthropathies.

• Female patient who is pregnant or nursing.

• Chronic use of narcotics

• Any other reason (in the judgment of the investigator).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Liposomal bupivacaine

• Ropivacaine

• Epinephrine

• Clonidine

• Saline

Locations

Country	Name	City	State
United States	Steadman Hawkins Clinic of the Carolinas - Greenville Health System	Greenville	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
The Hawkins Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain as assessed by Visual Analog Scale (VAS)	Pain, as assessed by Visual Analog Scale (VAS)	12 Months	No
Secondary	Function as assessed by Knee Society Score (KSS) and EQ-5D	Function, as assessed by Knee Society Score (KSS) and EQ-5D	12 Months	No
Secondary	Opioid consumption as assessed by dosage and frequency of narcotic usage	Opioid consumption, as assessed by dosage and frequency of narcotic usage	30 hours	No