Opioid Sparing Pain Management Strategy

Completed

• Conditions: Cardiac Surgical Procedures
• Interventions: Other: Multi-modal Opioid Sparing Pain Management Protocol

• Registration Number: NCT04269109
• Lead Sponsor: Prisma Health-Upstate

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.

Study Timeline

• Study Start: 2018-09-01
• Primary Completion: 2019-04-30
• Study First Submitted: 2020-02-11
• Study First Submitted QC: 2020-02-11
• Study First Posted: 2020-02-13
• Study Completion: 2021-03-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-12
• Last Update Posted: 2021-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control Cohort	Multi-modal Opioid Sparing Pain Management Protocol	A control cohort from September 1, 2018 - October 31, 2018
Intervention Cohort	Multi-modal Opioid Sparing Pain Management Protocol	An intervention cohort from March 1, 2019 - April 30, 2019

Primary Outcome Measures

Name	Time	Method
Morphine Milligram Equivalents Comparison	1 year	Compare the amount of morphine milligram equivalents consumed post operatively until discharge between groups.

Secondary Outcome Measures

Name	Time	Method
Ileus	1 year	Compare incidence of postoperative ileus between both cohorts.
Delirium	1 year	Compare incidence of delirium between both cohorts.

Trial Locations

Locations (1)

Prisma Health-Upstate; 🇺🇸 Greenville, South Carolina, United States