NCT02008370

Brief Summary

The investigators are presently using Exparel, a slow released local anesthestic, in patients undergoing minimally invasive cardiac surgery. The primary objective of this study is to assess the efficacy of EXPAREL when delivered into the thoracotomy and chest tube sites to provide prolonged postoperative analgesia in patients undergoing minimally invasive cardiac surgery. Efficacy will be assessed by: the effectiveness of analgesia as measured by the subject's overall postoperative pain scores and postsurgical analgesic use.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

November 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 6, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

October 4, 2019

Completed
Last Updated

October 4, 2019

Status Verified

September 1, 2019

Enrollment Period

2.6 years

First QC Date

December 6, 2013

Results QC Date

September 10, 2019

Last Update Submit

September 10, 2019

Conditions

Cardiac Disease

Keywords

minimally invasive cardiac surgeryExparel

Outcome Measures

Primary Outcomes (1)

  • Total Use of Analgesics

    The other primary endpoint of this study is the effectiveness of analgesia from the thoracotomy and chest tube site infiltrations as measured by the overall postsurgical analgesic use, (converted to morphine equivalents).

    5 days

Secondary Outcomes (2)

  • Patient Satisfaction

    10 days +/- 5 days

  • Pain Scores

    First 5 post-op days

Study Arms (1)

Exparel infiltration

EXPERIMENTAL

Exparel infiltrated into wound and chest tube sites

Drug: Exparel infiltration

Interventions

Exparel infiltrationDRUG

Exparel infiltrated into wound and chest tube sites

Also known as: Bupivacaine
Exparel infiltration

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-75 years inclusive and American Society of Anesthesiologists physical status 2-4.
  • Undergoing minimally invasive cardiac surgery.
  • Subjects must be physically and mentally able to participate in the study and complete all study assessments.
  • Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the proposed components of thoracotomy and chest tube sites infiltration.

You may not qualify if:

  • History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics
  • Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a thoracotomy and chest tube sites infiltration.
  • Any subject who in the opinion of the Investigator, might be harmed or be a poor candidate for participation in the study.
  • Any subject, who in the opinion of the Investigator, is on chronic pain medicine, including large doses of nonsteroidal antiinflammatory drugs.
  • Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Heart Diseases

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Dr G Trunfio
Organization
Maimonides Medical Center
gtrunfio@maimonidesmed.org
718-283-6000

Study Officials

  • Giuseppe Trunfio, MD

    Maimonides Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Anesthesia for Cardiac Surgery

Study Record Dates

First Submitted

December 6, 2013

First Posted

December 11, 2013

Study Start

November 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

October 4, 2019

Results First Posted

October 4, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)