Liposomal Bupivacaine for Post Operative Pain After Knee Replacement Surgery

Post-operative Pain Clinical Trial

Official title:

Liposomal Bupivacaine for Total Knee Arthroplasty Postoperative Analgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02274870
• Other study ID #: IRB: 14-237B
• Status: Completed
• Phase: Phase 4
• Start date: November 2014
• Est. completion date: January 2017

Study information

• Verified date: June 2018
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain

Intervention

Drug:
• Liposome Bupivacaine
Administered via local tissue infiltration around the knee joint
• Bupivacaine HCl
Administered via CFNB

Locations

Country	Name	City	State
United States	Franklin	Valley Stream	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Opioid Consumption		24hrs
Secondary	Mean Plasma Bupivicaine Level		72hrs
Secondary	Mean Plasma Bupivacaine Levels		48hrs
Secondary	Mean Plasma Bupivacaine Level		24hrs
Secondary	Mean Plasma Bupivacaine Level		12hrs
Secondary	Mean Plasma Bupivacaine Level		4hrs
Secondary	Mean Plasma Bupivacaine Level		2hrs
Secondary	Mean Plasma Bupivacaine Level		Baseline