Pain Control After Minimally Invasive Coronary Artery Bypass Grafting

Optimal Method of 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).

Study Overview

• Status: Terminated
• Conditions: Postoperative Pain; Medication Side Effects; Narcotic Requirement
• Intervention / Treatment: Drug: IV acetaminophen

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • La Crosse, Wisconsin, United States, 54601
      • Gundersen Lutheran Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.; Other Names: Tylenol; Ofirmev
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Gundersen Lutheran Medical Foundation
• Investigators: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: January 14, 2013
• First Submitted That Met QC Criteria: January 15, 2013
• First Posted (Estimate): January 17, 2013

Study Record Updates

• Last Update Posted (Estimate): December 21, 2016
• Last Update Submitted That Met QC Criteria: December 19, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: 2-12-12-001