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Pain Control After Minimally Invasive Coronary Artery Bypass Grafting

Optimal Method of Pain Control After Minimally Invasive Coronary Artery Bypass Grafting

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01770236
Enrollment
41
Registered
2013-01-17
Start date
2013-01-31
Completion date
2015-11-30
Last updated
2016-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medication Side Effects, Narcotic Requirement, Postoperative Pain

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).

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.

Sponsors

Gundersen Lutheran Medical Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Pain scoreParticipants will be followed for the duration of hospital stay, an expected average of 4 daysPain 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

MeasureTime frameDescription
Medication side effectsParticipants will be followed for the duration of hospital stay, an expected average of 4 daysAny side effects and need for additional narcotic medication will be collected throughout the duration of the hospital stay, an expected average of 4 days.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026