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Liposomal Bupivacaine for Post Operative Pain After Knee Replacement Surgery

Information source: North Shore Long Island Jewish Health System
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post-operative Pain

Intervention: Liposome Bupivacaine (Drug); Bupivicaine HCl (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: North Shore Long Island Jewish Health System

Official(s) and/or principal investigator(s):
Joseph Marino, MD, Principal Investigator, Affiliation: North Shore-LIJ Health System

Overall contact:
Joseph Marino, MD, Phone: 516-256-6014, Email: jmarino7@nshs.edu


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

Clinical Details

Official title: Liposomal Bupivacaine for Total Knee Arthroplasty Postoperative Analgesia

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Pain at movement

Secondary outcome:

Quadriceps muscle strength

Pain at rest

Opioid consumption

Plasma bupivicaine levels

Detailed description: This is a prospective, randomized, active controlled study in patients undergoing total knee replacement. We propose to compare the efficacy of Liposome Bupivacaine, in managing postoperative pain 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. We hypothesize that Liposome Bupivacaine will provide effective pain control and improved preservation of quadriceps muscle strength, in comparison to CFNB.


Minimum age: 18 Years. Maximum age: 74 Years. Gender(s): Both.


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


- 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.

Locations and Contacts

Joseph Marino, MD, Phone: 516-256-6014, Email: jmarino7@nshs.edu

Additional Information

Starting date: November 2014
Last updated: October 22, 2014

Page last updated: August 23, 2015

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