Pain Control After Minimally Invasive Coronary Artery Bypass Grafting
|ClinicalTrials.gov Identifier: NCT01770236|
Recruitment Status : Terminated (Study medication no longer available at institution)
First Posted : January 17, 2013
Last Update Posted : December 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain Medication Side Effects Narcotic Requirement||Drug: IV acetaminophen||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|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|
|Study Start Date :||January 2013|
|Primary Completion Date :||November 2015|
|Study Completion Date :||November 2015|
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).
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|