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Study medication no longer available at institution
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV acetaminophen | Experimental | 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) |
|
| On-Q Pain Pump catheter | No Intervention | Patients in this group will receive the current standard care which includes an intraoperative intercostal block + On-Q Pain Pump catheter (continuous dosing). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV acetaminophen | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score | 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. | Participants will be followed for the duration of hospital stay, an expected average of 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Medication side effects | 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. | Participants will be followed for the duration of hospital stay, an expected average of 4 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prem Rabindra, MD | Gundersen Health System | Principal Investigator |
| Kym Culp, MD | Gundersen Health System | Principal Investigator |
| Korey Zellner, PA-C | Gundersen Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gundersen Lutheran Health System | La Crosse | Wisconsin | 54601 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10391268 | Background | 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. | |
| 19752390 | Background | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 22, 2018 | |
| Reset | Jul 18, 2018 | |
| Release | Jan 4, 2019 | |
| Reset | Jan 28, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 22, 2018 | Jul 18, 2018 | |||
| Jan 4, 2019 |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| 10921543 | Background | 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. |
| Jan 28, 2019 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D064419 | Chemically-Induced Disorders |
| Aniline Compounds |
| D000588 | Amines |