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

Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02616367
• Other study ID #: 1503M66201
• Status: Withdrawn
• Phase: Phase 2
• Start date: December 2015
• Est. completion date: March 2017

Study information

• Verified date: April 2019
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty
• Knee
• Replacement

Intervention

Drug:
• liposomal bupivacaine Periarticular injection
Liposomal bupivacaine used for a periarticular injection in the knee
• Ropivacaine Periarticular Injection
Periarticular Injection for the knee with ropivacaine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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