NCT01770236

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at below P25 for phase_4 postoperative-pain

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 17, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

December 21, 2016

Status Verified

December 1, 2016

Enrollment Period

2.8 years

First QC Date

January 14, 2013

Last Update Submit

December 19, 2016

Conditions

Postoperative PainMedication Side EffectsNarcotic Requirement

Outcome Measures

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.

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

Secondary Outcomes (1)

  • Medication side effects

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

Study Arms (2)

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)

Drug: IV acetaminophen

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).

Interventions

IV acetaminophenDRUG

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
IV acetaminophen

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Coronary artery disease requiring surgical intervention
  • No prior sternotomy
  • Creatinine within normal limits (0.60 - 1.10 mg/dL)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gundersen Lutheran Health System

La Crosse, Wisconsin, 54601, United States

Location

Related Publications (3)

  • 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.

    PMID: 10391268BACKGROUND

  • 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.

    PMID: 19752390BACKGROUND

  • 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.

    PMID: 10921543BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeDrug-Related Side Effects and Adverse Reactions

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Academic researcher, on behalf of PI, Prem Rabindra, MD

Study Record Dates

First Submitted

January 14, 2013

First Posted

January 17, 2013

Study Start

January 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

December 21, 2016

Record last verified: 2016-12

Locations

US(1)