Pain Control After Minimally Invasive Coronary Artery Bypass Grafting
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).
Medication Side Effects
Drug: IV acetaminophen
|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|
- 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.
- 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.
|Study Start Date:||January 2013|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
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.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01770236
|United States, Wisconsin|
|Gundersen Lutheran Health System|
|La Crosse, Wisconsin, United States, 54601|
|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|