NCT02808728

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2014

Typical duration for phase_4

Status
unknown

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

Study Start

First participant enrolled

May 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
Last Updated

June 22, 2016

Status Verified

June 1, 2016

Enrollment Period

10 months

First QC Date

June 14, 2016

Last Update Submit

June 17, 2016

Conditions

OsteoarthritisTotal Knee ArthroplastyPain Management

Keywords

Total Knee ArthroplastyTotal Knee ReplacementExparelLiposomal BupivacaineRopivacainePostoperative Pain Management

Outcome Measures

Primary Outcomes (1)

  • Postoperative opioid consumption

    oral and intravenous narcotic consumption is recorded during hospital stay

    immediately post-operatively through hospital stay

Secondary Outcomes (4)

  • Hours to ambulate 100 feet

    immediately post-operatively through hospital stay

  • Length of hospital stay (hours)

    immediately post-operatively through hospital stay

  • Visual Analog Pain Score

    day 1 and day 2 after operation, 3 months, 6 months, and 1 year operatively

  • Knee Society Score

    3 months, 6 months, 1 year postoperatively

Study Arms (2)

Pain Cocktail with Ropivacaine

ACTIVE COMPARATOR

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

Drug: Pain Cocktail with Ropivacaine

Pain Cocktail with Exparel

EXPERIMENTAL

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

Drug: Pain Cocktail with Exparel

Interventions

Pain Cocktail with ExparelDRUG

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.

Also known as: liposomal bupivacaine
Pain Cocktail with Exparel
Pain Cocktail with RopivacaineDRUG

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

Pain Cocktail with Ropivacaine

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • DeClaire JH, Aiello PM, Warritay OK, Freeman DC. Effectiveness of Bupivacaine Liposome Injectable Suspension for Postoperative Pain Control in Total Knee Arthroplasty: A Prospective, Randomized, Double Blind, Controlled Study. J Arthroplasty. 2017 Sep;32(9S):S268-S271. doi: 10.1016/j.arth.2017.03.062. Epub 2017 Apr 6.

    PMID: 28478185DERIVED

MeSH Terms

Conditions

OsteoarthritisAgnosia

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Olayinka Warritay, MD

    DeClaire LaMacchia Orthopaedic Institute

    STUDY DIRECTOR

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

June 14, 2016

First Posted

June 22, 2016

Study Start

May 1, 2014

Primary Completion

March 1, 2015

Study Completion

June 1, 2016

Last Updated

June 22, 2016

Record last verified: 2016-06