Comparing Pain Relief Between Exparel® Injection vs. On-Q... | NCT02739230 | Trialant

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Comparing Pain Relief Between Exparel® Injection vs. On-Q... | NCT02739230 | Trialant

Studies
Comparing Pain Relief Between Exparel® Injection vs. On-Q Catheter as the Postsurgical Analgesia Following Total Knee Arthroplasty (TKA)

NCT02739230

Sponsor

Rothman Institute Orthopaedics

Status

Completed

Last Update Posted

Apr 15, 2016Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Osteoarthritis: Joint Replacement Surgery

Interventions

Exparel
On-Q pain intra-articular catheter

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

NCT02739230

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

ESmith2016

Secondary IDs

Not provided

Brief Title

Comparing Pain Relief Between Exparel® Injection vs. On-Q Catheter as the Postsurgical Analgesia Following Total Knee Arthroplasty (TKA)

Official Title

Not provided

Acronym

Not provided

Organization

Rothman Institute OrthopaedicsOTHER

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

No

Start Date

Dec 2013

Primary Completion Date

Oct 2015Actual

Completion Date

Not provided

First Submitted Date

Apr 7, 2016

First Submission Date that Met QC Criteria

Apr 14, 2016

First Posted Date

Apr 15, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2016

Last Update Posted Date

Apr 15, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Rothman Institute OrthopaedicsOTHER

Collaborators

Not provided

Oversight Module

No data available

No data is available for this block.

Description Module

Brief Summary

The goal of this research project is to evaluate the effectiveness of a novel treatment to control pain after Total Knee Arthroplasty (TKA). The proposed approach to manage pain and eliminate risks associated with catheters is the use of Exparel injection into the joint at the time of surgery.

Detailed Description

Not provided

Conditions Module

Conditions

Osteoarthritis: Joint Replacement Surgery

Keywords

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exparel Injection	Active Comparator		Drug: Exparel
On-Q intraarthicual catheter placement	Active Comparator		Drug: On-Q pain intra-articular catheter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exparel	Drug		Exparel Injection
On-Q pain intra-articular catheter

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total Morphine and morphine equivalent consumption		96 hours post-op

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults scheduled to undergo primary total knee replacement
Willing and able to provide informed consent

Accepts Healthy Volunteers

No

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

No data available

No data is available for this block.

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.

Parallel Assignment

Intervention Model Description

Not provided

Primary Purpose

Treatment

Observational Model

Not provided

Time Perspective

Not provided

Masking Info

Masking

Double

Masking Description

Not provided

Who Masked

ParticipantCare Provider

Drug

On-Q intraarthicual catheter placement