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Pain Control After Minimally Invasive Coronary Artery Bypass Grafting

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Kara Kallies, Gundersen Lutheran Medical Foundation
ClinicalTrials.gov Identifier:
NCT01770236
First received: January 14, 2013
Last updated: January 15, 2013
Last verified: January 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: January 2013
Estimated Primary Completion Date: December 2013 (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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: January 14, 2013
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 20, 2014