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Preoperative Education

Primary Purpose

Postoperative Pain

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video on analgesic education
Video on general perioperative education
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Analgesic education

General perioperative education

Arm Description

Outcomes

Primary Outcome Measures

Opioid consumption
Opioid consumption during the initial 72 hours after surgery.

Secondary Outcome Measures

Pain Score
Pain scores documented in PACU
Pain Score
Pain scores documented on surgical floor
Satisfaction with post operative pain management
Using Likert scale 0-10 with 0 means not satisfied and 10 completely satisfied

Full Information

First Posted
July 16, 2021
Last Updated
October 2, 2023
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04970069
Brief Title
Preoperative Education
Official Title
The Effect of Preoperative Education
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 25, 2021 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
672 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Analgesic education
Arm Type
Active Comparator
Arm Title
General perioperative education
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Video on analgesic education
Intervention Description
A four minute video informing the patient about opioids.
Intervention Type
Other
Intervention Name(s)
Video on general perioperative education
Intervention Description
A four minute video informing the patient about general perioperative process.
Primary Outcome Measure Information:
Title
Opioid consumption
Description
Opioid consumption during the initial 72 hours after surgery.
Time Frame
72 hours after surgery
Secondary Outcome Measure Information:
Title
Pain Score
Description
Pain scores documented in PACU
Time Frame
every 15 minutes
Title
Pain Score
Description
Pain scores documented on surgical floor
Time Frame
every 4 hours
Title
Satisfaction with post operative pain management
Description
Using Likert scale 0-10 with 0 means not satisfied and 10 completely satisfied
Time Frame
3 days post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alparslan Turan, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

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Preoperative Education

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