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Pain Control After Minimally Invasive Coronary Artery Bypass Grafting

Primary Purpose

Postoperative Pain, Medication Side Effects, Narcotic Requirement

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
IV acetaminophen
Sponsored by
Gundersen Lutheran Medical Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gundersen Lutheran Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

IV acetaminophen

On-Q Pain Pump catheter

Arm Description

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)

Patients in this group will receive the current standard care which includes an intraoperative intercostal block + On-Q Pain Pump catheter (continuous dosing).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 14, 2013
Last Updated
December 19, 2016
Sponsor
Gundersen Lutheran Medical Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01770236
Brief Title
Pain Control After Minimally Invasive Coronary Artery Bypass Grafting
Official Title
Optimal Method of Pain Control After Minimally Invasive Coronary Artery Bypass Grafting
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
Study medication no longer available at institution
Study Start Date
January 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gundersen Lutheran Medical Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Medication Side Effects, Narcotic Requirement

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV acetaminophen
Arm Type
Experimental
Arm Description
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)
Arm Title
On-Q Pain Pump catheter
Arm Type
No Intervention
Arm Description
Patients in this group will receive the current standard care which includes an intraoperative intercostal block + On-Q Pain Pump catheter (continuous dosing).
Intervention Type
Drug
Intervention Name(s)
IV acetaminophen
Other Intervention Name(s)
Tylenol, Ofirmev
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain score
Description
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.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 4 days
Secondary Outcome Measure Information:
Title
Medication side effects
Description
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.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prem Rabindra, MD
Organizational Affiliation
Gundersen Health System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kym Culp, MD
Organizational Affiliation
Gundersen Health System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Korey Zellner, PA-C
Organizational Affiliation
Gundersen Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gundersen Lutheran Health System
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10391268
Citation
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.
Results Reference
background
PubMed Identifier
19752390
Citation
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.
Results Reference
background
PubMed Identifier
10921543
Citation
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.
Results Reference
background

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Pain Control After Minimally Invasive Coronary Artery Bypass Grafting

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