NCT02426164

Brief Summary

Liposomal bupivacaine is a novel local anesthetic designed for prolonged pain relief. Despite its long-acting analgesic potential, liposomal bupivacaine is significantly more expensive than other local anesthetic alternatives. The primary aim of this investigation is to examine whether or not liposomal bupivacaine provides superior pain relief or clinically significant opioid-sparing effects versus a control to justify its cost.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 24, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

March 22, 2016

Status Verified

April 1, 2015

Enrollment Period

2 years

First QC Date

April 14, 2015

Last Update Submit

March 18, 2016

Conditions

Pain, PostoperativeArthroplasty, Replacement, KneeOsteoarthritis

Outcome Measures

Primary Outcomes (4)

  • Mean visual analog scale (VAS) pain scores

    Self-reported pain scores from 0=no pain to 10=severe pain

    Night of surgery

  • Mean visual analog scale (VAS) pain scores

    Self-reported pain scores from 0=no pain to 10=severe pain

    Post-operative day 1

  • Mean visual analog scale (VAS) pain scores

    Self-reported pain scores from 0=no pain to 10=severe pain

    Post-operative day 2

  • Pain assessment phone call

    Subjects will be called on post-operative day three by one of the investigators of the study. Subjects will be asked to rate their current pain level from 1 to 10 and to rate their worst pain level from 1 to 10 that day.

    Post-operative day 3

Secondary Outcomes (1)

  • Complications

    Complications will be followed for the duration of patients' hospital stay, an expected average of 2-3 days.

Study Arms (2)

Liposomal bupivacaine

ACTIVE COMPARATOR

Periarticular infiltration of 20cc of liposomal bupivacaine with 20cc of normal saline administered prior to cementation of knee implants

Drug: Liposomal bupivacaine

bupivacaine HCl, morphine, epinephrine, methylprednisolone

ACTIVE COMPARATOR

Periarticular infiltration of 24c of bupivacaine HCl, 0.8cc morphine, 0.3cc epinephrine, and 1cc of methylprednisolone administered prior to cementation of knee implants

Drug: bupivacaine HCl, morphine, epinephrine, methylprednisolone

Interventions

Liposomal bupivacaineDRUG

Periarticular infiltration of the liposomal bupivacaine with 20cc of normal saline

Also known as: Exparel
Liposomal bupivacaine
bupivacaine HCl, morphine, epinephrine, methylprednisoloneDRUG

Periarticular infiltration of 24c of bupivacaine HCl, 0.8cc morphine, 0.3cc epinephrine, and 1cc of methylprednisolone

bupivacaine HCl, morphine, epinephrine, methylprednisolone

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing a primary unilateral total knee arthroplasty by the PI of the trial

You may not qualify if:

  • Patients with a sensitivity to marcaine
  • Pregnant or lactating women
  • Non-English speaking individuals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miller Orthopedic Specialists

Council Bluffs, Iowa, 51503, United States

Location

MeSH Terms

Conditions

Pain, PostoperativeOsteoarthritis

Interventions

BupivacaineMorphineEpinephrineMethylprednisolone

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring Compounds

Study Officials

  • Clifford K Boese, MD

    Miller Orthopedic Specialists

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2015

First Posted

April 24, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

March 22, 2016

Record last verified: 2015-04

Locations

US(1)