NCT03182933

Liposomal Bupivacaine Versus Standard Bupivacaine in the Adductor Canal for Total Knee Arthroplasty

Terminated Phase 4 Results posted Last updated 25 June 2019

What this trial tests

Phase 4 trial testing Peripheral Nerve Blockade in Pain in 64 participants. Terminated before completion.

Timeline

30 May 2017

Primary endpoint
16 July 2018

16 July 2018

Quick facts

Lead sponsor	University of Wisconsin, Madison
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	64
Start date	30 May 2017
Primary completion	16 July 2018
Estimated completion	16 July 2018
Sites	1 location across United States

Drugs / interventions tested

• Peripheral Nerve Blockade — full drug profile →
• 10 meter walk test on post-operative day 1
• In person and over the phone questionnaire
• Force transduction of quadriceps strength

Conditions studied

• Pain — all drugs for Pain →

Sponsor

University of Wisconsin, Madison

Who can join

Adults 18 to 80, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

10 Meter Walk Test Primary · 24 hours

Time to comfortably walk 10 meters as deemed safe by physical therapy

Group	Value	95% CI
Liposomal Bupivacaine Group	17.1	± 8.9
Standard Bupivacaine Group	13.4	± 5.2

Pain Scores Secondary · Day 0, Day 1, Day 2, Day 3

Visual Analog Scores on a scale of 1-10, where 1 is pain free and 10 is the most pain.

Day 0

Group	Value	95% CI
Liposomal Bupivacaine Group	4.9	± 2.4
Standard Bupivacaine Group	5.7	± 2.2

Day 1

Group	Value	95% CI
Liposomal Bupivacaine Group	4.1	± 2.3
Standard Bupivacaine Group	4.5	± 2.4

Day 2

Group	Value	95% CI
Liposomal Bupivacaine Group	4.4	± 2.0
Standard Bupivacaine Group	5.9	± 2.6

Day 3

Group	Value	95% CI
Liposomal Bupivacaine Group	4.5	± 2.2
Standard Bupivacaine Group	5	± 2.3

Opioid Consumption in Morphine Equivalents Secondary · Day 0 (OR), Day 0 (PACU), Day 1, Day 2, Day 3

Total opioid consumption will be measured in all patients over the course of 3 days and converted to oral morphine equivalents so that it can be statistically compared.

Day 0 (OR)

Group	Value	95% CI
Liposomal Bupivacaine Group	2.3	± 6.9
Standard Bupivacaine Group	0.5	± 2.7

Day 0 (PACU)

Group	Value	95% CI
Liposomal Bupivacaine Group	7.1	± 8.4
Standard Bupivacaine Group	5.9	± 11.4

Day 1

Group	Value	95% CI
Liposomal Bupivacaine Group	51.2	± 29.2
Standard Bupivacaine Group	66.1	± 36.0

Day 2

Group	Value	95% CI
Liposomal Bupivacaine Group	39.5	± 28.6
Standard Bupivacaine Group	54.8	± 37.9

Day 3

Group	Value	95% CI
Liposomal Bupivacaine Group	25.8	± 33.0
Standard Bupivacaine Group	28.2	± 20.4

Number of Participants Who Experienced Nausea Secondary · Day 0, Day 1, Day 2, Day 3

Post operative nausea and vomiting as documented in the PACU and volunteered in an over the phone interview

Day 0 (PACU)

Group	Value	95% CI
Liposomal Bupivacaine Group	1
Standard Bupivacaine Group	0

Day 1

Group	Value	95% CI
Liposomal Bupivacaine Group	12
Standard Bupivacaine Group	11

Day 2

Group	Value	95% CI
Liposomal Bupivacaine Group	3
Standard Bupivacaine Group	6

Day 3

Group	Value	95% CI
Liposomal Bupivacaine Group	4
Standard Bupivacaine Group	6

Quadriceps Strength Secondary · 24 hours

Quadriceps Strength is measured in pounds of force using the kiio device, reported as the highest value of 3 collected.

Group	Value	95% CI
Liposomal Bupivacaine Group	16.5	± 11
Standard Bupivacaine Group	19.2	± 12.8

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 72 hours. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Liposomal Bupivacaine Group

Serious: 0/31 (0%)

Deaths: 0/31

Standard Bupivacaine Group

Serious: 0/32 (0%)

Deaths: 0/32

Other adverse events (1 terms — click to expand)

Reaction	System	Liposomal Bupivacaine Group	Standard Bupivacaine Group
Falls	Musculoskeletal and connective tissue disorders	—	—

Data from ClinicalTrials.gov NCT03182933 adverse events section.

Sponsor's own description

Study will evaluate the effect of liposomal bupivacaine versus standard bupivacaine on physical therapy measures and pain scores as well as opiate consumption.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.