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Postop Pain in the MICS Patients Versus Sternotomy Patients

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ClinicalTrials.gov Identifier: NCT04003584
Recruitment Status : Completed
First Posted : July 1, 2019
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
Bradley Tenny, Atrium Health

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.

Condition or disease Intervention/treatment
Pain, Postoperative Surgery Procedure: Coronary bypass surgery

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Study Type : Observational
Actual Enrollment : 179 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Is Postoperative Pain Different in the MICS CABG Cohort V. the Traditional Sternotomy Cohort
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : January 30, 2018
Actual Study Completion Date : January 30, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Highest reported pain level, on the standard 0-10 pain scale, post extubation day one [ Time Frame: The first 24 hours post extubation ]
    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.

  2. Highest reported pain level, on the standard 0-10 pain scale, on the day of discharge. [ Time Frame: Within 24 hours from discharge ]
    The highest reported pain, measured by the nursing staff on within 24hrs from discharge.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04003584


Locations
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United States, North Carolina
Atrium Health
Charlotte, North Carolina, United States, 28210
Sponsors and Collaborators
Atrium Health
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Responsible Party: Bradley Tenny, Nurse Practitioner, Atrium Health
ClinicalTrials.gov Identifier: NCT04003584    
Other Study ID Numbers: IRB file #09-17-29E
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: If requested we would not mind providing guidance on postoperative pain assessments/likert scales.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bradley Tenny, Atrium Health:
Minimally invasive
Cardiac Surgery
Postoperative Pain
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations