Clinical trial NCT04269109: Opioid Sparing Pain Management Strategy
Official title: A Multi-modal, Opioid Sparing Pain Management Strategy in Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgical Procedures
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This retrospective study is a self-controlled comparison of patients undergoing cardiovascular surgery by cardiovascular surgeons at Greenville Memorial Hospital.

Brief summary: The purpose of this research study is to compare the amount of morphine milligram equivalents consumed post operatively until discharge between the control cohort and intervention cohort.

Detailed description: Retrospective data will be collected on patients admitted to Prisma Health-Upstate Greenville Memorial Hospital in the Cardiovascular Intensive Care Unit following cardiovascular surgery. They will be divided into two cohorts, a control cohort from September 1, 2018 - October 31, 2018 and an intervention cohort from March 1, 2019 - April 30, 2019. A study investigator will assess each participant's electronic medical record through the electronic medical record database - EPIC to determine eligibility per the protocol. Demographic information will be collected, including age, date of birth, race, sex, height, weight, and ethnicity. Extubation and reintubation status will be collected along with medical history, type of cardiovascular procedure, medications, length of stay, pain scores, complications, and labs.

Eligibility criteria: Inclusion Criteria:

* Adult patients 18 and over
* Patients who underwent cardiac surgery requiring a coronary pulmonary bypass machine during September 1, 2018 - April 30, 2019

Exclusion Criteria:

* Patients being placed on Extracorporeal Membrane Oxygenation

Primary outcomes:
measure: Morphine Milligram Equivalents Comparison
timeFrame: 1 year
Secondary outcomes:
measure: Ileus
timeFrame: 1 year
measure: Delirium
timeFrame: 1 year
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Prisma Health-Upstate
state: South Carolina
Study officials:
affiliation: Prisma Health-Upstate
name: Caroline McKillop, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Li M, Zhang J, Gan TJ, Qin G, Wang L, Zhu M, Zhang Z, Pan Y, Ye Z, Zhang F, Chen X, Lin G, Huang L, Luo W, Guo Q, Wang E. Enhanced recovery after surgery pathway for patients undergoing cardiac surgery: a randomized clinical trial. Eur J Cardiothorac Surg. 2018 Sep 1;54(3):491-497. doi: 10.1093/ejcts/ezy100.