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