Preoperative Education

July 9, 2024 updated by: The Cleveland Clinic

The Effect of Preoperative Education on Postoperative Opioid Consumption

The investigators will evaluate the effect of preoperative education on postoperative opioid.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators propose a randomized trial to be performed at the Cleveland Clinic. Patients will be assigned to: 1) an educational video focused on postoperative analgesia modalities, opioids, and realistic pain expectations (analgesic education); or, 2) an educational video focused on other aspects of the perioperative experience.

Study Type

Interventional

Enrollment (Actual)

1057

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Modified informed consent
  • Adults ≥18 years
  • American Society of Anaesthesiologists physical status 1-4
  • Scheduled for hip arthroplasty, laparoscopy assisted colorectal surgery
  • Personal visit the PACE clinic
  • Anticipated overnight postoperative hospitalization
  • Reasonable English fluency

Exclusion Criteria:

  • Opioid use for more than 30 consecutive days within three preoperative months, at a daily dose of 15 mg or more of morphine or equivalent
  • Regional block or epidural analgesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Analgesic education
Other: Video on analgesic education
A four minute video informing the patient about opioids.
Placebo Comparator: General perioperative education
Other: Video on general perioperative education
A four minute video informing the patient about general perioperative process.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid Consumption
Time Frame: 72 hours after surgery
Opioid consumption (morphine milligrams equivalent) during the initial 72 hours after surgery.
72 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time-weighted Average Pain Scores
Time Frame: 72 hours after surgery, or until discharge, whichever was earlier
Time-weighted average of pain scores obtained from electronic medical records. Pain scores were measured using the numeric rating scale ranging from 0-10, with 0 indicating the lowest pain (better) and 10 the highest pain (worse). Pain scores were recorded approximately every 15 minutes in the post-anesthesia care unit and then every 4 hours in the ward.
72 hours after surgery, or until discharge, whichever was earlier
Satisfaction With Post Operative Pain Management
Time Frame: 3 days after surgery
Patient satisfaction measured using Likert scale 0-10 with 0 meaning not satisfied and 10 meaning completely satisfied.
3 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Alparslan Turan, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2021

Primary Completion (Actual)

September 15, 2023

Study Completion (Actual)

September 15, 2023

Study Registration Dates

First Submitted

July 16, 2021

First Submitted That Met QC Criteria

July 16, 2021

First Posted (Actual)

July 21, 2021

Study Record Updates

Last Update Posted (Actual)

July 25, 2024

Last Update Submitted That Met QC Criteria

July 9, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-626

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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