Comparison of Comparison of Ropivacaine and Liposomal Bupivacaine for Total Knee Arthroplasty

Comparison Between Ropivacaine and Liposomal Bupivacaine Periarticular Injections for Pain Relief After Total Knee Arthroplasty

This is a randomized prospective outcomes study comparing two groups of patients. One group will receive liposomal bupivacaine for a periarticular injection. The other will receive ropivacaine for periarticular injection for pain relief after Total Knee Arthroplasty. the primary objective of this study is to determine if liposomal bupivacaine provides superior pain control (decreased maximal pain scores within the first 72 hours post surgery) when compared to ropivacaine when injected in a periarticular injection.

Study Overview

• Status: Withdrawn
• Conditions: Arthroplasty; Knee; Replacement
• Intervention / Treatment: Drug: liposomal bupivacaine Periarticular injection; Drug: Ropivacaine Periarticular Injection

Detailed Description

The current standard of care at our institution for pain relief in Total Knee Arthroplasty is ropivacaine injectate into the knee for acute postoperative pain relief. This provides pain relief for a duration of 6-18 hours after surgery. All patients in this study will also receive multimodal analgesia following surgery in both arms of the study. This will be the first study to prospectively analyze these two regimens.

Study group 1 (ropivacaine arm) consist of 100 mL (1 mL ketorolac, 2.5 mL morphine, 28.95 mL normal saline, 300 mcg of epinephrine, and 200 mg ropivacaine) Study group 2 will consist of 100 mL (one syringe with 50 mL total: 40 mL 0.25% bupivacaine, 300 mcg epinephrine, 1 mL ketorolac, 2.5 mL morphine, 6.5 mL normal saline) (one syringe with 50 mL total: 20 mL liposomal bupivacaine 30 mL normal saline). The periarticular injection will occur at the end of the procedure. Adequate analgesia will be defined as < 3 VAS at rest and if VAS is greater that 3 adjustments in oral or intravenous pain medications. Postoperatively the study team will evaluate for any signs of complications. Pain scores and opioid usage will be recorded daily while the subject is in the hospital. A quality of recovery survey will be completed at 72 hours post injection. All subjects will be contacted by phone at day 14 to determine if there have been any adverse events and report their pain level.

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients undergoing primary total knee arthroplasty surgery 18-80.

Exclusion Criteria:

• Patient on chronic anticoagulation
• Allergy to local anesthetics, nsaids, or opioids
• Patients who remain intubated for one week after surgery or who are unable to provide information as to their feelings of pain post-operatively for the first week post- operatively
• Daily use of opioid for more than three weeks
• Lack of patient cooperation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: liposomal bupivacaine Periarticular injection; Will consist of 100 mL (one syringe with 50 mL total: 40 mL 0.25% bupivacaine, 300 mcg epinephrine, 1 mL ketorolac, 2.5 mL morphine, 6.5 mL normal saline) (one syringe with 50 mL total: 20 mL liposomal bupivacaine 30 mL normal saline).	Drug: liposomal bupivacaine Periarticular injection; Liposomal bupivacaine used for a periarticular injection in the knee; Other Names: Exparel
Active Comparator: Ropivacaine Periarticular Injection; Will consist of 100 mL (1 mL ketorolac, 2.5 mL morphine, 28.95 mL normal saline, 300 mcg of epinephrine, and 200 mg ropivacaine	Drug: Ropivacaine Periarticular Injection; Periarticular Injection for the knee with ropivacaine; Other Names: Norapin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain control measure on pain scale of 1-10	to determine if liposomal bupivacaine provides superior pain control (decreased maximal pain control (decreased maximal pain scores) when compared to ropivacaine when injected in a periarticular injection.	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
decreased maximal pain on pain scale of 1-10	Liposomal bupivacaine via a periarticular injection will result in a decreased maximal pain and improved quality of recovery when compared to ropivacaine when injected in a periarticular injection	72 hours

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Roberto D Blanco, University of Minnesota

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: November 24, 2015
• First Submitted That Met QC Criteria: November 25, 2015
• First Posted (Estimate): November 26, 2015

Study Record Updates

• Last Update Posted (Actual): May 1, 2019
• Last Update Submitted That Met QC Criteria: April 29, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine; Ropivacaine
• Other Study ID Numbers: 1503M66201