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

NCT02616367 | Withdrawn Phase 2

• 1 other identifier: 1503M66201
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Arthroplasty; Replacement; Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• decreased maximal pain on pain scale of 1-10

  72 hours

Study Arms (2)

liposomal bupivacaine Periarticular injection

EXPERIMENTAL

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

Ropivacaine Periarticular Injection

ACTIVE COMPARATOR

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

Interventions

liposomal bupivacaine Periarticular injection DRUG

Liposomal bupivacaine used for a periarticular injection in the knee

Also known as: Exparel

liposomal bupivacaine Periarticular injection

Ropivacaine Periarticular Injection DRUG

Periarticular Injection for the knee with ropivacaine

Also known as: Norapin

Ropivacaine Periarticular Injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Officials

• Roberto D Blanco

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: November 26, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: May 1, 2019

Record last verified: 2019-04