Effectiveness of Intraoperative Exparel for Postoperative Pain Control in Total Knee Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Does the use of periarticular Exparel in total knee arthroplasty prove to more effectively manage post operative pain control than another local analgesic, Ropivacaine, when both are used as part of a multimodal pain management approach?

The investigators hypothesize that Exparel, a bupivacaine liposomal injectable suspension, will improve total knee arthroplasty postoperative pain with significant improvement of early function outcomes.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Local Infiltration Analgesia With and Without EXPAREL Following Total Knee Arthroplasty

NCT02713490

Pain

COMPLETED PHASE4

Comparing Exparel & Ropivacaine for Pain Relief in Total Knee Arthroplasty

NCT02607579

Knee Osteoarthritis

UNKNOWN NA

A Comparison of Exparel Local Anesthetic in Total Knee Arthroplasty (TKA) Patients

NCT02765815

Osteoarthritis, Knee Arthroplasty, Replacement, Knee

WITHDRAWN PHASE4

Femoral Nerve Block Compared to Exparel in Total Knee Replacement

NCT02473198

Osteoarthritis Pain

UNKNOWN PHASE3

Exparel for Total Shoulder Pain

NCT03739021

Chronic Shoulder Pain

NOT_YET_RECRUITING PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The investigators use a double blind, controlled, randomized study to examine the effectiveness of periarticular Exparel in total knee arthroplasty postoperative pain control as well as effect on early mobilization and length of hospital stay when compared to another local analgesic (Ropivacaine) when both are used as part of a multimodal pain management approach.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis Total Knee Arthroplasty Pain Management

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pain Cocktail with Ropivacaine

patients given the standard intra-articular "pain cocktail" injection, consisting of ropivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 100cc preparation.

given in one single dose

Group Type ACTIVE_COMPARATOR

Pain Cocktail with Ropivacaine

Intervention Type DRUG

pain cocktail: ropivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 100cc preparation.

Pain Cocktail with Exparel

patients given a similar intra-articular injection consisting of bupivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 80cc preparation as well as an injection of Exparel, 20cc of 1.3% Exparel, to total 100cc.

given in one single dose

Group Type EXPERIMENTAL

Pain Cocktail with Exparel

Intervention Type DRUG

pain cocktail: bupivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 80cc preparation as well as an injection of Exparel (bupivacaine liposome injectable suspension), 20cc of 1.3% Exparel, to total 100cc.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pain Cocktail with Exparel

pain cocktail: bupivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 80cc preparation as well as an injection of Exparel (bupivacaine liposome injectable suspension), 20cc of 1.3% Exparel, to total 100cc.

Intervention Type DRUG

Pain Cocktail with Ropivacaine

pain cocktail: ropivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 100cc preparation.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

liposomal bupivacaine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient undergoing Total Knee Arthroplasty with Dr. J.H. DeClaire
* 18 years of age or older
* Primary diagnosis of osteoarthritis of the knee
* Opioid naïve patient (according to FDA guidelines)

Exclusion Criteria

* Prior knee replacement
* Prior use of narcotics for chronic pain management
* Inflammatory arthritis (Rheumatoid arthritis, Lupus, etc.)
* Unicompartmental knee replacement
* Bilateral Total Knee Arthroplasty
* Opioid Tolerant as defined by the FDA: Patients who are taking, for one week or longer, at least:

\> 60 mg oral morphine/day \> 25μg transdermal fentanyl/hour \> 30 mg oral oxycodone/day \> 8 mg oral hydromorphone/day \> 25 mg oral oxymorphone/day

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes