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Local Anesthetic
Exparel (Group 2) for Pain
Phase 3
Waitlist Available
Led By Carl Talmo, MD
Research Sponsored by The New England Baptist Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
• Patients between the ages of 18 - 73 who are undergoing primary, unilateral, Total Knee Replacement at the New England Baptist Hospital in Boston, Massachusetts are eligible to participate.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
Study Summary
The main objective of the study is to determine if intrarticular injection with liposomal bupivicaine (Exparel) provides better postoperative pain relief and functional outcome following total knee replacement (TKR) than the current standard New England Baptist Hospital regimen of femoral nerve block combined with intraarticular injection of a standard bupivicaine solution.
Eligible Conditions
- Pain
- Osteoarthritis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain Relief measured by VAS Questionnaire
Secondary outcome measures
Functional Ability measured by the KSS Questionnaire Score
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Exparel (Group 2)Experimental Treatment3 Interventions
Group 2 will receive standard perioperative pain management for TKR; will undergo placebo femoral nerve block under ultrasound guidance with normal saline (NS) 20 cc. Following femoral bone cuts they will receive local anesthetic injection mixture of 30cc 0.25% bupivicaine with epinephrine 20 cc of preservative free normal saline, 30mg of toradol and 10 mg of morphine sulfate into the periarticular tissues including periosteum, joint capsule and posterior capsule of the knee joint and collateral ligaments and subcutaneous tissues. Prior to cementing prosthesis, a second injection with mixture of 20mL 1.3% Exparel and 40mL normal saline solution will be injected into the same tissues, joint capsules and collateral ligaments.
Group II: Femoral Nerve Block (Group 1)Active Control1 Intervention
In group1 (standard group) all patients receive the standard current perioperative pain management protocol for TKR.
The patient will then undergo an ultrasound guided femoral nerve block with bupivacaine 0.25% 20 cc. Intraoperatively prior to cementing of the TKR, patients will also receive a local anesthetic injection of a mixture of 30cc 0.25% bupivicaine with epinephrine, 30mg of toradol and 10 mg of morphine sulfate into the posterior capsule of the knee joint. Postoperatively patients will receive narcotic pain medication on a PRN basis.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketorolac
FDA approved
Morphine
FDA approved
Bupivacaine
FDA approved
Find a Location
Who is running the clinical trial?
The New England Baptist HospitalLead Sponsor
9 Previous Clinical Trials
2,832 Total Patients Enrolled
Carl Talmo, MDPrincipal InvestigatorNew England Baptist Hospital
Frequently Asked Questions
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