- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04625868
Effectiveness of a Preoperative Educational Video for Reducing Opioid Consumption After Hand Surgery
September 8, 2021 updated by: David Kalainov, Northwestern University
This study seeks to determine if watching a preoperative educational video influences opioid consumption and proper disposal following elective hand surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study seeks to determine if watching a preoperative educational video influences opioid consumption and proper disposal following elective hand surgery.
Patients undergoing elective hand surgery are randomized to either watch a preoperative educational video or not.
Patients are asked to record their pain medication usage postoperatively, as well as their daily pain levels and satisfaction with their pain control after surgery.
Study Type
Interventional
Enrollment (Actual)
119
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
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern Memorial Hospital
-
-
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
Genders Eligible for Study
All
Description
Inclusion Criteria:
- undergoing elective hand surgery
- surgeon is planning to prescribe opioids for postoperative pain control
Exclusion Criteria:
- emergent surgery
- surgeon not planning to prescribe opioids for postoperative pain control
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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Soft tissue surgery - preoperative video
Patients > 18 years old undergoing elective hand surgery (soft tissue) for which the surgeon is planning to prescribe opioids for postoperative pain control.
|
Patients will watch a preoperative educational video on proper opioid use and disposal.
|
NO_INTERVENTION: Soft tissue surgery - no video
Patients > 18 years old undergoing elective hand surgery (soft tissue) for which the surgeon is planning to prescribe opioids for postoperative pain control.
|
|
EXPERIMENTAL: Bone/joint surgery - preoperative video
Patients > 18 years old undergoing elective hand surgery (bone/joint) for which the surgeon is planning to prescribe opioids for postoperative pain control.
|
Patients will watch a preoperative educational video on proper opioid use and disposal.
|
NO_INTERVENTION: Bone/joint surgery - no video
Patients > 18 years old undergoing elective hand surgery (bone/joint) for which the surgeon is planning to prescribe opioids for postoperative pain control.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morphine milliequivalents consumed in 2 weeks postoperatively
Time Frame: 2 weeks after surgery
|
Total morphine mEq consumed in 2 weeks after surgery
|
2 weeks after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale
Time Frame: 2 weeks after surgery
|
Average daily Visual Analog Scaled pain score recorded after surgery.
Pain will be recorded on a scale from 0 (no pain) to 10 (worst pain possible).
|
2 weeks after surgery
|
Patient satisfaction
Time Frame: 7-10 days after surgery
|
Patient satisfaction with pain control after surgery.
Satisfaction will be measured on a Likert scale with the following question: "How satisfied have you been with your pain management after surgery?".
Answer choices are: Very unsatisfied, unsatisfied, neutral, satisfied, very satisfied.
|
7-10 days after surgery
|
Proper disposal
Time Frame: 2 weeks after surgery
|
Self-reported proper disposal of unused opioids after surgery.
Patients will be asked in a postoperative survey if they used all of the pills in their initial postoperative prescription.
If they did not, they will be asked "Have you disposed of your unused opioids via a DEA-approved method (I.e. at a pharmacy or other safe location?)"
as a yes or no question.
|
2 weeks after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: David M. Kalainov, M.D., Northwestern University
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)
May 29, 2020
Primary Completion (ACTUAL)
March 1, 2021
Study Completion (ACTUAL)
March 1, 2021
Study Registration Dates
First Submitted
July 3, 2020
First Submitted That Met QC Criteria
November 9, 2020
First Posted (ACTUAL)
November 12, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 10, 2021
Last Update Submitted That Met QC Criteria
September 8, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00211034
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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