Liposomal Bupivacaine for Post Operative Pain After Knee Replacement Surgery

NCT ID: NCT02274870

Last Updated: 2018-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2017-01-31

Brief Summary

Continuous femoral nerve blocks (CFNB) provide effective pain control to patients undergoing total knee replacement (TKR). However the resulting motor blockade can lead to decreased quadriceps muscle strength and delayed functional recovery.The purpose of this study is to compare the effect of Liposome Bupivacaine infiltration into the knee to CFNB on pain control and functional recovery

Detailed Description

This is a prospective, randomized, active controlled study in patients undergoing total knee replacement. The objective of this study is to compare the efficacy of Liposome Bupivacaine, in managing postoperative pain, to standard of care CFNB. Following informed consent, patients will be randomized to one of two groups, Liposome Bupivacaine or active control, CFNB group.

266 mg Liposome Bupivacaine plus Bupivicaine HCL (150mg) will be administered via local joint infiltration around the knee joint prior to wound closure. In the control group a CFNB will be placed for 48hrs prior to surgery. Outcomes measured included pain at rest, movement and quadriceps muscle strength on the first and second postoperative day.

It is hypothesized that Liposome Bupivacaine will provide effective pain control and improved preservation of quadriceps muscle strength, in comparison to CFNB.

Conditions

Post-operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liposome Bupivacaine,

Liposome Bupivacaine 266mg, Knee Infiltration

Group Type: EXPERIMENTAL

Liposome Bupivacaine

Intervention Type: DRUG

Administered via local tissue infiltration around the knee joint

Bupivacaine HCl

Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs)

Group Type: ACTIVE_COMPARATOR

Bupivacaine HCl

Intervention Type: DRUG

Administered via CFNB

Interventions

Liposome Bupivacaine

Administered via local tissue infiltration around the knee joint

Intervention Type: DRUG

Bupivacaine HCl

Administered via CFNB

Intervention Type: DRUG

Other Intervention Names

Bupivacaine Liposome, Injectable Suspension; Standard of Care

Eligibility Criteria

Inclusion Criteria

• ASA Status I-III
• Scheduled to undergo primary unilateral total knee arthroplasty

Exclusion Criteria

• Patients who are pregnant or nursing
• Alcohol or narcotic dependence within the last 2 years
• Condition requiring regular use of analgesia that may confound post surgical assessments as determined by principle investigator
• BMI > 40kg/m2
• Contraindication to acetaminophen, morphine, oxycodone, ketorolac, epinephrine, or pathological conditions potentially aggravated by epinephrine
• Allergies to amide-type local anesthetics
• Any disease condition or lab result that could complicate a patients postoperative recovery
• History of hypotension
• Abnormal liver, renal or cardiac function
• Other physical, mental or medical conditions that, in the opinion of the investigator, make study participation inadvisable.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Joseph Marino M.D.

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph Marino, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

Franklin

Valley Stream, New York, United States

Countries

United States

Other Identifiers

IRB: 14-237B

Identifier Type: -

Identifier Source: org_study_id