Effectiveness of Intraoperative Exparel for Postoperative Pain Control in Total Knee Arthroplasty

Osteoarthritis Clinical Trial

Official title:

Effectiveness of Intraoperative Exparel, a Bupivacaine Liposome Injectable Suspension, for Postoperative Pain Control in Total Knee Arthroplasty: A Prospective, Randomized, Double Blind, Controlled Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02808728
• Other study ID #: WIRB 20131914
• Status: Active, not recruiting
• Phase: Phase 4
• First received: June 14, 2016
• Last updated: June 17, 2016
• Start date: May 2014
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: DeClaire LaMacchia Orthopaedic Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Does the use of periarticular Exparel in total knee arthroplasty prove to more effectively manage post operative pain control than another local analgesic, Ropivacaine, when both are used as part of a multimodal pain management approach?

The investigators hypothesize that Exparel, a bupivacaine liposomal injectable suspension, will improve total knee arthroplasty postoperative pain with significant improvement of early function outcomes.

Description:

The investigators use a double blind, controlled, randomized study to examine the effectiveness of periarticular Exparel in total knee arthroplasty postoperative pain control as well as effect on early mobilization and length of hospital stay when compared to another local analgesic (Ropivacaine) when both are used as part of a multimodal pain management approach.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 2016
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient undergoing Total Knee Arthroplasty with Dr. J.H. DeClaire

• 18 years of age or older

• Primary diagnosis of osteoarthritis of the knee

• Opioid naïve patient (according to FDA guidelines)

Exclusion Criteria:

• Prior knee replacement

• Prior use of narcotics for chronic pain management

• Inflammatory arthritis (Rheumatoid arthritis, Lupus, etc.)

• Unicompartmental knee replacement

• Bilateral Total Knee Arthroplasty

• Opioid Tolerant as defined by the FDA: Patients who are taking, for one week or longer, at least:

• 60 mg oral morphine/day

• 25µg transdermal fentanyl/hour

• 30 mg oral oxycodone/day

• 8 mg oral hydromorphone/day

• 25 mg oral oxymorphone/day

Study Design

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

Related Conditions & MeSH terms

• Osteoarthritis
• Pain Management
• Pain, Postoperative
• Total Knee Arthroplasty

Intervention

Drug:
• Pain Cocktail with Exparel
pain cocktail: bupivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 80cc preparation as well as an injection of Exparel (bupivacaine liposome injectable suspension), 20cc of 1.3% Exparel, to total 100cc.
• Pain Cocktail with Ropivacaine
pain cocktail: ropivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 100cc preparation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
DeClaire LaMacchia Orthopaedic Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative opioid consumption	oral and intravenous narcotic consumption is recorded during hospital stay	immediately post-operatively through hospital stay	No
Secondary	Hours to ambulate 100 feet		immediately post-operatively through hospital stay	No
Secondary	Length of hospital stay (hours)	Number of hours the patient stays at the hospital following operation	immediately post-operatively through hospital stay	No
Secondary	Visual Analog Pain Score		day 1 and day 2 after operation, 3 months, 6 months, and 1 year operatively	No
Secondary	Knee Society Score		3 months, 6 months, 1 year postoperatively	No