Postop Pain in the MICS Patients Versus Sternotomy Patients

Is Postoperative Pain Different in the MICS CABG Cohort V. the Traditional Sternotomy Cohort

To adequately assess postoperative pain in the coronary artery bypass surgical population a multicentered retrospective chart review was carried out; the study utilized a nonexperimental comparative descriptive study design. The retrospective review was conducted over a six-month time frame, consisting of June 2017 through November 2017, at two hospitals within the same organization. The data collection process began in late December of 2017 and January of 2018. The assessment of postop pain was performed by using a standard 11-point numeric pain rating scale on post extubation day one and the day of discharge.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Surgery
• Intervention / Treatment: Procedure: Coronary bypass surgery

• Study Type: Observational
• Enrollment (Actual): 179

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Atrium Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The retrospective review was conducted over a six-month time frame, consisting of June 2017 through November 2017, at two hospitals within the same organization. One of the hospitals was a level one trauma center in the center of a major southeastern metropolitan area, and the second was a community hospital within the suburbs of the same city's geographic limits. All included patients fit the above inclusion and exclusion criteria per the aforementioned time frame and involved healthcare centers.

Description

Inclusion Criteria:

• Patients who had an isolated coronary artery bypass surgery at Charlotte Medical Center (CMC) and CMC-Pineville
• Minimally invasive cardiac surgery
• Traditional sternotomy cardiac surgery

Exclusion Criteria:

• Documented history of any chronic pain syndromes requiring active treatment
• The "relative" recent requirement of narcotic analgesic use for pain relief prior to operation
• Any CABG operation that inadvertently resulted in an operative surgical complication
• Patient cases that resulted in a readmission within 30 days from surgery.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Minimally Invasive Cardiac Bypass patients	Procedure: Coronary bypass surgery; Reviewed postoperative coronary bypass patients and compared postoperative pain levels
Traditional Sternotomy Cardiac Bypass patients	Procedure: Coronary bypass surgery; Reviewed postoperative coronary bypass patients and compared postoperative pain levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Highest reported pain level, on the standard 0-10 pain scale, post extubation day one	The highest recorded pain level, taken by the nursing staff, on the day following. extubation. Utilized day post due to the washout/possible confounding variable of sedation administration within 24hrs.	The first 24 hours post extubation
Highest reported pain level, on the standard 0-10 pain scale, on the day of discharge.	The highest reported pain, measured by the nursing staff on within 24hrs from discharge.	Within 24 hours from discharge

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Jeko Madjarov, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): January 30, 2018
• Study Completion (Actual): January 30, 2018

Study Registration Dates

• First Submitted: June 21, 2019
• First Submitted That Met QC Criteria: June 28, 2019
• First Posted (Actual): July 1, 2019

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 26, 2023
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Postoperative Pain; Cardiac Surgery; Minimally invasive
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: IRB file #09-17-29E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: If requested we would not mind providing guidance on postoperative pain assessments/likert scales.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No