Pain Control After Minimally Invasive Coronary Artery Bypass Grafting
NCT ID: NCT01770236
Last Updated: 2016-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
41 participants
INTERVENTIONAL
2013-01-31
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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)
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.
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).
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Coronary artery disease requiring surgical intervention
* No prior sternotomy
* Creatinine within normal limits (0.60 - 1.10 mg/dL)
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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Gundersen Lutheran Medical Foundation
OTHER
Responsible Party
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Kara Kallies
Academic researcher, on behalf of PI, Prem Rabindra, MD
Principal Investigators
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Prem Rabindra, MD
Role: PRINCIPAL_INVESTIGATOR
Gundersen Health System
Kym Culp, MD
Role: PRINCIPAL_INVESTIGATOR
Gundersen Health System
Korey Zellner, PA-C
Role: PRINCIPAL_INVESTIGATOR
Gundersen Health System
Locations
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Gundersen Lutheran Health System
La Crosse, Wisconsin, United States
Countries
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References
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Walther T, Falk V, Metz S, Diegeler A, Battellini R, Autschbach R, Mohr FW. Pain and quality of life after minimally invasive versus conventional cardiac surgery. Ann Thorac Surg. 1999 Jun;67(6):1643-7. doi: 10.1016/s0003-4975(99)00284-2.
McGinn JT Jr, Usman S, Lapierre H, Pothula VR, Mesana TG, Ruel M. Minimally invasive coronary artery bypass grafting: dual-center experience in 450 consecutive patients. Circulation. 2009 Sep 15;120(11 Suppl):S78-84. doi: 10.1161/CIRCULATIONAHA.108.840041.
Berger MM, Berger-Gryllaki M, Wiesel PH, Revelly JP, Hurni M, Cayeux C, Tappy L, Chiolero R. Intestinal absorption in patients after cardiac surgery. Crit Care Med. 2000 Jul;28(7):2217-23. doi: 10.1097/00003246-200007000-00006.
Other Identifiers
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2-12-12-001
Identifier Type: -
Identifier Source: org_study_id