NCT00673712

Brief Summary

The main goals of the study are as follows: (1) to determine the correlation between pain management using continuous infusion of local anesthetics and the incidence of pneumonia and surgical infection in cardiac surgery patients; and (2) to evaluate the relationship between hospital-acquired pneumonia and surgical infection and patient outcomes, including length of hospital stay.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
647

participants targeted

Target at P75+ for phase_4 surgery

Timeline
Completed

Started Apr 2008

Longer than P75 for phase_4 surgery

Geographic Reach
1 country

8 active sites

Status
completed

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

April 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 6, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2008

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

May 4, 2015

Completed
Last Updated

January 19, 2018

Status Verified

April 1, 2015

Enrollment Period

4.4 years

First QC Date

May 6, 2008

Results QC Date

April 3, 2015

Last Update Submit

December 18, 2017

Conditions

SurgeryPneumoniaSurgical Site Infection

Keywords

Coronary Artery Bypass Graft SurgeryPneumoniaSurgical Site Infection

Outcome Measures

Primary Outcomes (1)

  • Hospital Acquired Pneumonia

    Pneumonia diagnosed during hospitalization

    30 days postoperative

Secondary Outcomes (2)

  • Surgical Site Infection

    30 days postoperative

  • Hospital Length of Stay

    primary admission

Study Arms (2)

Continuous Sternal Block

EXPERIMENTAL

Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system

Device: Continuous Sternal Block

Opioid based analgesia

ACTIVE COMPARATOR

Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics

Drug: Opioid based analgesia

Interventions

Continuous Sternal BlockDEVICE

Elastomeric Pump for Continuous Infusion of Local Anesthetic

Also known as: ON-Q, PainBuster
Continuous Sternal Block
Opioid based analgesiaDRUG

Opioid Analgesic agents delivered by: PCA on demand mode IV injections PRN IM injections PRN Oral PRN

Also known as: PCA
Opioid based analgesia

Eligibility Criteria

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

You may qualify if:

  • Men and women, \>18 years of age;
  • Scheduled for elective cardiac surgical procedure, including coronary revasculari-zation or valve surgery;
  • Provision of informed consent

You may not qualify if:

  • Patients with a prior allergic reaction or dependency to morphine, Demerol, Di-laudid, Fentanyl, Marcaine (bupivacaine), lidocaine or Naropin (ropivacaine);
  • Cardiac transplant patients
  • Inability to perform follow-up assessments;
  • Pre-existing infection (pneumonia or surgical site)
  • Repeat of primary surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

St. Vincents East

Birmingham, Alabama, 35235, United States

Location

Christianna Care Health System

Newark, Delaware, 19713, United States

Location

University of Kentucky Medical Center

Lexington, Kentucky, 40506, United States

Location

Ochsner

New Orleans, Louisiana, 70121, United States

Location

Cape Fear valley Hospital

Fayetteville, North Carolina, 28304, United States

Location

Medcentral Hospital

Mansfield, Ohio, 44903, United States

Location

Methodist Hospital

Houston, Texas, 77030, United States

Location

Waukesha Medical Center

West Allis, Wisconsin, 53227, United States

Location

MeSH Terms

Conditions

PneumoniaSurgical Wound Infection

Interventions

Passive Cutaneous Anaphylaxis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesWound InfectionPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Skin TestsImmunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic TechniquesAntigen-Antibody ReactionsImmune System Phenomena

Results Point of Contact

Title
Sr. Director Clinical Research
Organization
Halyard Health
alan.dine@hyh.com
5132538033

Study Officials

  • Ali Husain, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2008

First Posted

May 7, 2008

Study Start

April 1, 2008

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

January 19, 2018

Results First Posted

May 4, 2015

Record last verified: 2015-04

Locations

US(8)