Postop Pain in the MICS Patients Versus Sternotomy Patients

NCT04003584 | Completed

• 1 other identifier: IRB file #09-17-29E
• Study Type: observational
• Target: 179
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative; Surgery

Keywords

Minimally invasive; Cardiac Surgery; Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Minimally Invasive Cardiac Bypass patients

Procedure: Coronary bypass surgery

Traditional Sternotomy Cardiac Bypass patients

Procedure: Coronary bypass surgery

Interventions

Coronary bypass surgery PROCEDURE

Reviewed postoperative coronary bypass patients and compared postoperative pain levels

Minimally Invasive Cardiac Bypass patients; Traditional Sternotomy Cardiac Bypass patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health

Charlotte, North Carolina, 28210, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Jeko Madjarov, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: July 1, 2019
• Study Start: June 1, 2017
• Primary Completion: January 30, 2018
• Study Completion: January 30, 2018
• Last Updated: March 28, 2023

Record last verified: 2019-06

Locations

US (1)