Pain Control After Minimally Invasive Coronary Artery Bypass Grafting

Phase 4

Terminated

• Conditions: Postoperative Pain; Medication Side Effects; Narcotic Requirement
• Interventions: Drug: IV acetaminophen

• Registration Number: NCT01770236
• Lead Sponsor: Gundersen Lutheran Medical Foundation

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-14
• Study First Submitted QC: 2013-01-15
• Study First Posted: 2013-01-17
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-19
• Last Update Posted: 2016-12-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV acetaminophen	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)

Primary Outcome Measures

Name	Time	Method
Pain score	Participants will be followed for the duration of hospital stay, an expected average of 4 days	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

Name	Time	Method
Medication side effects	Participants will be followed for the duration of hospital stay, an expected average of 4 days	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.

Trial Locations

Locations (1)

Gundersen Lutheran Health System; 🇺🇸 La Crosse, Wisconsin, United States