NCT04269109

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

8 months

First QC Date

February 11, 2020

Last Update Submit

April 12, 2021

Conditions

Cardiac Surgical Procedures

Outcome Measures

Primary Outcomes (1)

  • Morphine Milligram Equivalents Comparison

    Compare the amount of morphine milligram equivalents consumed post operatively until discharge between groups.

    1 year

Secondary Outcomes (2)

  • Ileus

    1 year

  • Delirium

    1 year

Study Arms (2)

Control Cohort

A control cohort from September 1, 2018 - October 31, 2018

Other: Multi-modal Opioid Sparing Pain Management Protocol

Intervention Cohort

An intervention cohort from March 1, 2019 - April 30, 2019

Other: Multi-modal Opioid Sparing Pain Management Protocol

Interventions

Multi-modal Opioid Sparing Pain Management ProtocolOTHER

Incorporating multimodal opioid sparing ERAS techniques for cardiac surgery patients should show a decrease in the amount of opioids received, reduction in incidence of chronic pain, ileus, delirium, and potential for opioid addiction post-operatively. Between the dates of November 2018 through February 2019, a multi-modal, opioid sparing pain management protocol was evolving and a protocol was put into place. This study will compare outcomes before and after implementation of the protocol between the dates of September 1, 2018 - October 31, 2018 and March 1, 2019 - April 30, 2019.

Control CohortIntervention Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This retrospective study is a self-controlled comparison of patients undergoing cardiovascular surgery by cardiovascular surgeons at Greenville Memorial Hospital.

You may qualify if:

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

You may not qualify if:

  • Patients being placed on Extracorporeal Membrane Oxygenation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prisma Health-Upstate

Greenville, South Carolina, 29605, United States

Location

Related Publications (3)

  • Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.

    PMID: 26827847BACKGROUND

  • Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.

    PMID: 30113379BACKGROUND

  • 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.

    PMID: 29514224BACKGROUND

Study Officials

  • Caroline McKillop, MD

    Prisma Health-Upstate

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 11, 2020

First Posted

February 13, 2020

Study Start

September 1, 2018

Primary Completion

April 30, 2019

Study Completion

March 1, 2021

Last Updated

April 13, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)