Preoperative Education

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04970069
• Collaborator: (none)
• Enrollment: 672
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 58.2
• Patients Per Site Per Month: 11.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Other: Video on analgesic education; Other: Video on general perioperative education	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 672 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Effect of Preoperative Education
• Actual Study Start Date: Jul 25, 2021
• Anticipated Primary Completion Date: Dec 1, 2025
• Anticipated Study Completion Date: Jun 1, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Opioid consumption [72 hours after surgery]

   Opioid consumption during the initial 72 hours after surgery.

Secondary Outcome Measures

1. Pain Score [every 15 minutes]

   Pain scores documented in PACU

2. Pain Score [every 4 hours]

   Pain scores documented on surgical floor

3. Satisfaction with post operative pain management [3 days post surgery]

   Using Likert scale 0-10 with 0 means not satisfied and 10 completely satisfied

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• The Cleveland Clinic

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT04970069
• Other Study ID Numbers: 21-626
• First Posted: Jul 21, 2021
• Last Update Posted: Sep 29, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative; Analgesics

Study Results

No Results Posted as of Sep 29, 2021