Comparing Pain Relief Between Exparel® Injection vs. On-Q Catheter as the Postsurgical Analgesia Following Total Knee Arthroplasty (TKA)

Osteoarthritis: Joint Replacement Surgery Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02739230
• Other study ID #: ESmith2016
• Status: Completed
• Phase: N/A
• First received: April 7, 2016
• Last updated: April 14, 2016
• Start date: December 2013

Study information

• Verified date: April 2016
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The goal of this research project is to evaluate the effectiveness of a novel treatment to control pain after Total Knee Arthroplasty (TKA). The proposed approach to manage pain and eliminate risks associated with catheters is the use of Exparel injection into the joint at the time of surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adults scheduled to undergo primary total knee replacement

2. Willing and able to provide informed consent

Study Design

Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis: Joint Replacement Surgery

Intervention

Drug:
• Exparel

• On-Q pain intra-articular catheter

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Morphine and morphine equivalent consumption		96 hours post-op	No