Liposomal Bupivacaine for Post Operative Pain After Knee Replacement Surgery

Phase 4

Completed

• Conditions: Post-operative Pain
• Interventions: Drug: Liposome Bupivacaine; Drug: Bupivacaine HCl

• Registration Number: NCT02274870
• Lead Sponsor: Northwell Health

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.

Study Timeline

• Study First Submitted: 2014-10-22
• Study First Submitted QC: 2014-10-22
• Study First Posted: 2014-10-24
• Study Start: 2014-11
• Primary Completion: 2016-12
• Study Completion: 2017-01
• Results First Submitted: 2018-02-22
• Status Verified: 2018-06
• Results First Submitted QC: 2018-06-12
• Last Update Submitted: 2018-06-12
• Results First Posted: 2018-06-14
• Last Update Posted: 2018-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liposome Bupivacaine,	Liposome Bupivacaine	Liposome Bupivacaine 266mg, Knee Infiltration
Bupivacaine HCl	Bupivacaine HCl	Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs)

Primary Outcome Measures

Name	Time	Method
Pain Intensity at Movement	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 Outcome Measures

Name	Time	Method
Mean Plasma Bupivacaine Level	Baseline
Opioid Consumption	24hrs
Mean Plasma Bupivicaine Level	72hrs
Mean Plasma Bupivacaine Levels	48hrs
Pain Intensity at Rest	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.

Trial Locations

Locations (1)

Franklin; 🇺🇸 Valley Stream, New York, United States