Pain Control After Minimally Invasive Coronary Artery Bypass Grafting

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01770236
• Other study ID #: 2-12-12-001
• Status: Terminated
• Phase: Phase 4
• First received: January 14, 2013
• Last updated: December 19, 2016
• Start date: January 2013
• Est. completion date: November 2015

Study information

• Verified date: December 2016
• Source: Gundersen Lutheran Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Drug-Related Side Effects and Adverse Reactions
• Medication Side Effects
• Narcotic Requirement
• Pain, Postoperative
• Postoperative Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Gundersen Lutheran Health System	La Crosse	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Gundersen Lutheran Medical Foundation

Country where clinical trial is conducted

United States, 

References & Publications (3)

Berger MM, Berger-Gryllaki M, Wiesel PH, Revelly JP, Hurni M, Cayeux C, Tappy L, Chioléro R. Intestinal absorption in patients after cardiac surgery. Crit Care Med. 2000 Jul;28(7):2217-23. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No