Clinical trial NCT02274870: Liposomal Bupivacaine for Post Operative Pain After Knee Replacement Surgery
Official title: Liposomal Bupivacaine for Total Knee Arthroplasty Postoperative Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-operative Pain
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2014-10-24
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain Intensity at Movement
timeFrame: 24hrs
Secondary outcomes:
measure: Pain Intensity at Rest
timeFrame: 24hrs
measure: Opioid Consumption
timeFrame: 24hrs
measure: Mean Plasma Bupivicaine Level
timeFrame: 72hrs
measure: Mean Plasma Bupivacaine Levels
timeFrame: 48hrs
measure: Mean Plasma Bupivacaine Level
timeFrame: 24hrs
measure: Mean Plasma Bupivacaine Level
timeFrame: 12hrs
measure: Mean Plasma Bupivacaine Level
timeFrame: 4hrs
measure: Mean Plasma Bupivacaine Level
timeFrame: 2hrs
measure: Mean Plasma Bupivacaine Level
timeFrame: Baseline
Other outcomes:
Locations:
city: Valley Stream
country: United States
facility: Franklin
state: New York
Study officials:
affiliation: Northwell Health
name: Joseph Marino, MD
role: PRINCIPAL_INVESTIGATOR
References: