Liposomal Bupivacaine for Post Operative Pain After Knee Replacement Surgery

Liposomal Bupivacaine for Total Knee Arthroplasty Postoperative Analgesia

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

Study Overview

• Status: Completed
• Conditions: Post-operative Pain
• Intervention / Treatment: Drug: Liposome Bupivacaine; Drug: Bupivacaine HCl

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Valley Stream, New York, United States, 11580
      • Franklin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liposome Bupivacaine,; Liposome Bupivacaine 266mg, Knee Infiltration	Drug: Liposome Bupivacaine; Administered via local tissue infiltration around the knee joint; Other Names: Bupivacaine Liposome, Injectable Suspension
Active Comparator: Bupivacaine HCl; Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs)	Drug: Bupivacaine HCl; Administered via CFNB; Other Names: Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity at Movement	Pain intensity at maximum knee flexion measured using a 0-10 visual analog scale. Higher values represent a higher pain intensity or worse outcome.	24hrs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity at Rest	Pain intensity at maximum knee flexion measured using a 0-10 visual analog scale. Higher values represent a higher pain intensity or worse outcome.	24hrs
Opioid Consumption		24hrs
Mean Plasma Bupivicaine Level		72hrs
Mean Plasma Bupivacaine Levels		48hrs
Mean Plasma Bupivacaine Level		24hrs
Mean Plasma Bupivacaine Level		12hrs
Mean Plasma Bupivacaine Level		4hrs
Mean Plasma Bupivacaine Level		2hrs
Mean Plasma Bupivacaine Level		Baseline

Collaborators and Investigators

• Sponsor: Northwell Health
• Investigators: Principal Investigator: Joseph Marino, MD, Northwell Health

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: October 22, 2014
• First Submitted That Met QC Criteria: October 22, 2014
• First Posted (Estimate): October 24, 2014

Study Record Updates

• Last Update Posted (Actual): June 14, 2018
• Last Update Submitted That Met QC Criteria: June 12, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: IRB: 14-237B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED