Liposomal Bupivacaine for Post Operative Pain After Knee Replacement Surgery
Primary Purpose
Post-operative Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Liposome Bupivacaine
Bupivacaine HCl
Sponsored by
About this trial
This is an interventional treatment trial for Post-operative Pain
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.
Sites / Locations
- Franklin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Liposome Bupivacaine,
Bupivacaine HCl
Arm Description
Liposome Bupivacaine 266mg, Knee Infiltration
Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Opioid Consumption
Mean Plasma Bupivicaine Level
Mean Plasma Bupivacaine Levels
Mean Plasma Bupivacaine Level
Mean Plasma Bupivacaine Level
Mean Plasma Bupivacaine Level
Mean Plasma Bupivacaine Level
Mean Plasma Bupivacaine Level
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02274870
Brief Title
Liposomal Bupivacaine for Post Operative Pain After Knee Replacement Surgery
Official Title
Liposomal Bupivacaine for Total Knee Arthroplasty Postoperative Analgesia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liposome Bupivacaine,
Arm Type
Experimental
Arm Description
Liposome Bupivacaine 266mg, Knee Infiltration
Arm Title
Bupivacaine HCl
Arm Type
Active Comparator
Arm Description
Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs)
Intervention Type
Drug
Intervention Name(s)
Liposome Bupivacaine
Other Intervention Name(s)
Bupivacaine Liposome, Injectable Suspension
Intervention Description
Administered via local tissue infiltration around the knee joint
Intervention Type
Drug
Intervention Name(s)
Bupivacaine HCl
Other Intervention Name(s)
Standard of Care
Intervention Description
Administered via CFNB
Primary Outcome Measure Information:
Title
Pain Intensity at Movement
Description
Pain intensity at maximum knee flexion measured using a 0-10 visual analog scale.
Higher values represent a higher pain intensity or worse outcome.
Time Frame
24hrs
Secondary Outcome Measure Information:
Title
Pain Intensity at Rest
Description
Pain intensity at maximum knee flexion measured using a 0-10 visual analog scale.
Higher values represent a higher pain intensity or worse outcome.
Time Frame
24hrs
Title
Opioid Consumption
Time Frame
24hrs
Title
Mean Plasma Bupivicaine Level
Time Frame
72hrs
Title
Mean Plasma Bupivacaine Levels
Time Frame
48hrs
Title
Mean Plasma Bupivacaine Level
Time Frame
24hrs
Title
Mean Plasma Bupivacaine Level
Time Frame
12hrs
Title
Mean Plasma Bupivacaine Level
Time Frame
4hrs
Title
Mean Plasma Bupivacaine Level
Time Frame
2hrs
Title
Mean Plasma Bupivacaine Level
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Marino, MD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Franklin
City
Valley Stream
State/Province
New York
ZIP/Postal Code
11580
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Liposomal Bupivacaine for Post Operative Pain After Knee Replacement Surgery
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