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TerminatedNCT01770236Updated Dec 21, 2016

Pain Control After Minimally Invasive Coronary Artery Bypass Grafting

A Phase 4 interventional study of IV acetaminophen in Postoperative Pain, Medication Side Effects and Narcotic Requirement, sponsored by Gundersen Lutheran Medical Foundation. Terminated at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-12-21.

Sponsored by Gundersen Lutheran Medical Foundation · Phase 4, Interventional, and Supportive care

Why this study was terminated
Study medication no longer available at institution
Phase
Phase 4
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
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Study 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).

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Conditions studied

  • Postoperative Pain
  • Medication Side Effects
  • Narcotic Requirement
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In context

Drug-Related Side Effects and Adverse Reactions

437 studies on the registry are indexed under Drug-Related Side Effects and Adverse Reactions; 76 are open to participants now.

This study's enrollment of 41 is below the median of 103 across 255 interventional studies indexed under Drug-Related Side Effects and Adverse Reactions.

Browse Drug-Related Side Effects and Adverse Reactions studies →

Lead sponsor

Gundersen Lutheran Medical Foundation is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • 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

  • 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).

Interventions

  • DrugIV 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.

    Also known as: Tylenol, Ofirmev

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 days

Secondary outcomes

  1. 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.

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 days

07

Study locations

1 site
  • Gundersen Lutheran Health System
    La Crosse, Wisconsin 54601, United States
08

References and documents

Publications

  • 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. PubMed 10391268 ↗
  • 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. PubMed 19752390 ↗
  • 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. PubMed 10921543 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01770236
Lead sponsor
Gundersen Lutheran Medical Foundation
Responsible party
Kara Kallies (Academic researcher, on behalf of PI, Prem Rabindra, MD, Gundersen Lutheran Medical Foundation) — Principal investigator
First posted
Jan 17, 2013
Start date
Jan 2013
Primary completion
Nov 2015
Completion
Nov 2015
Last update
Dec 21, 2016

Study contacts

Prem Rabindra, MD
principal investigator · Gundersen Health System
Kym Culp, MD
principal investigator · Gundersen Health System
Korey Zellner, PA-C
principal investigator · Gundersen Health System

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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