Liposomal Bupivacaine for Total Knee Arthroplasty Postoperative Analgesia
Overview
- Phase
- Phase 4
- Intervention
- Liposome Bupivacaine
- Conditions
- Post-operative Pain
- Sponsor
- Northwell Health
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Pain Intensity at Movement
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Joseph Marino M.D.
Physician
Northwell Health
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.
Arms & Interventions
Liposome Bupivacaine,
Liposome Bupivacaine 266mg, Knee Infiltration
Intervention: Liposome Bupivacaine
Bupivacaine HCl
Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs)
Intervention: Bupivacaine HCl
Outcomes
Primary Outcomes
Pain Intensity at Movement
Time Frame: 24hrs
Pain intensity at maximum knee flexion measured using a 0-10 visual analog scale. Higher values represent a higher pain intensity or worse outcome.
Secondary Outcomes
- Opioid Consumption(24hrs)
- Mean Plasma Bupivicaine Level(72hrs)
- Mean Plasma Bupivacaine Levels(48hrs)
- Mean Plasma Bupivacaine Level(Baseline)
- Pain Intensity at Rest(24hrs)