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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04970069
Other study ID # 21-626
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date July 25, 2021
Est. completion date June 2026

Study information

Verified date October 2023
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 672
Est. completion date June 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Video on analgesic education
A four minute video informing the patient about opioids.
Video on general perioperative education
A four minute video informing the patient about general perioperative process.

Locations

Country Name City State
United States Cleveland Clinic Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Opioid consumption Opioid consumption during the initial 72 hours after surgery. 72 hours after surgery
Secondary Pain Score Pain scores documented in PACU every 15 minutes
Secondary Pain Score Pain scores documented on surgical floor every 4 hours
Secondary Satisfaction with post operative pain management Using Likert scale 0-10 with 0 means not satisfied and 10 completely satisfied 3 days post surgery
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