Opioid Sparing Pain Management Strategy

NCT ID: NCT04269109

Last Updated: 2021-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2021-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Surgical Procedures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Cohort

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

Multi-modal Opioid Sparing Pain Management Protocol

Intervention Type OTHER

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.

Intervention Cohort

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

Multi-modal Opioid Sparing Pain Management Protocol

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Multi-modal Opioid Sparing Pain Management Protocol

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Prisma Health-Upstate

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Caroline McKillop, MD

Role: PRINCIPAL_INVESTIGATOR

Prisma Health-Upstate

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Prisma Health-Upstate

Greenville, South Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 26827847 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30113379 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29514224 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pro00085849

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Perioperative Pain Self-Management Program Trial
NCT04979429 ACTIVE_NOT_RECRUITING NA
Precision Analgesia for Cardiac Surgery
NCT05612399 NOT_YET_RECRUITING
Gender and Opioid Consumption
NCT03006627 UNKNOWN NA