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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

About this trial

This is an interventional treatment trial for Post-operative Pain

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Full Information

NCT ID

NCT02274870

First Posted

October 22, 2014

Last Updated

June 12, 2018

Sponsor

Northwell Health

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

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

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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