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OpenTrials
Completed

NCT Number: NCT04003584

Postop Pain in the MICS Patients Versus Sternotomy Patients

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Atrium Health

Charlotte, North Carolina, 28210, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Coronary bypass surgery

Procedure

Reviewed postoperative coronary bypass patients and compared postoperative pain levels

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 1, 2019
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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