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Pain Control After Minimally Invasive Coronary Artery Bypass Grafting

This study has been terminated.
(Study medication no longer available at institution)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01770236
First Posted: January 17, 2013
Last Update Posted: December 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kara Kallies, Gundersen Lutheran Medical Foundation
  Purpose
The purpose of this study is to compare postoperative pain control after minimally invasive coronary artery bypass grafting for patients who receive an intercostal block (an anesthetic medicine injected in an area under the ribs) in the operating room and IV acetaminophen (Tylenol) to those who receive an intercostal block and On-Q pain pump catheter (a balloon pump attached to 2 small tubes near your procedure site that automatically delivers pain medicine).

Condition Intervention Phase
Postoperative Pain Medication Side Effects Narcotic Requirement Drug: IV acetaminophen Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Optimal Method of Pain Control After Minimally Invasive Coronary Artery Bypass Grafting

Resource links provided by NLM:


Further study details as provided by Kara Kallies, Gundersen Lutheran Medical Foundation:

Primary Outcome Measures:
  • Pain score [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 days ]
    Pain scores will be assessed using a Numerical Rating Scale (NRS) (an 11-point scale, 0 through 10, with 0 representing 'No pain' and 10 representing 'Worst imaginable pain'). Pain scores will be entered by nursing staff every 2 hours in ICU, and every 6 hours on the floor for the duration of the hospital stay, an expected average of 4 days.


Secondary Outcome Measures:
  • Medication side effects [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 days ]
    Any side effects and need for additional narcotic medication will be collected throughout the duration of the hospital stay, an expected average of 4 days.


Enrollment: 41
Study Start Date: January 2013
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IV acetaminophen
Patients in this group will receive intraoperative intercostal block + IV acetaminophen (1000 mg every 6 hours for adults and weight-based for any patient under 50 kg)
Drug: IV acetaminophen
Patients randomized to the IV acetaminophen group will receive IV acetaminophen (1000 mg every 6 hours for adults and weight-based for any patient under 50 kg)instead of an On-Q pain pump catheter.
Other Names:
  • Tylenol
  • Ofirmev
No Intervention: On-Q Pain Pump catheter
Patients in this group will receive the current standard care which includes an intraoperative intercostal block + On-Q Pain Pump catheter (continuous dosing).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Coronary artery disease requiring surgical intervention
  • No prior sternotomy
  • Creatinine within normal limits (0.60 - 1.10 mg/dL)

Exclusion Criteria:

  • Less than 18 years of age
  • Inability to provide consent or complete a written survey
  • Previous history of sternotomy
  • Contraindications to MICS-CABG or to any of the components of the 2 analgesic regimens
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01770236


Locations
United States, Wisconsin
Gundersen Lutheran Health System
La Crosse, Wisconsin, United States, 54601
Sponsors and Collaborators
Gundersen Lutheran Medical Foundation
Investigators
Principal Investigator: Prem Rabindra, MD Gundersen Health System
Principal Investigator: Kym Culp, MD Gundersen Health System
Principal Investigator: Korey Zellner, PA-C Gundersen Health System
  More Information

Publications:
Responsible Party: Kara Kallies, Academic researcher, on behalf of PI, Prem Rabindra, MD, Gundersen Lutheran Medical Foundation
ClinicalTrials.gov Identifier: NCT01770236     History of Changes
Other Study ID Numbers: 2-12-12-001
First Submitted: January 14, 2013
First Posted: January 17, 2013
Last Update Posted: December 21, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Pain, Postoperative
Drug-Related Side Effects and Adverse Reactions
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Chemically-Induced Disorders
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics


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