Back to resultsEffectiveness of a Preoperative Educational Video for Reducing Opioid Consumption After Hand Surgery
Primary Purpose
Opioid Use, Hand Injuries and Disorders, Surgery
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational video
Sponsored by
About this trial
This is an interventional prevention trial for Opioid Use
Eligibility Criteria
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
Sites / Locations
- Northwestern Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
No Intervention
Experimental
No Intervention
Arm Label
Soft tissue surgery - preoperative video
Soft tissue surgery - no video
Bone/joint surgery - preoperative video
Bone/joint surgery - no video
Arm Description
Patients > 18 years old undergoing elective hand surgery (soft tissue) for which the surgeon is planning to prescribe opioids for postoperative pain control.
Patients > 18 years old undergoing elective hand surgery (soft tissue) for which the surgeon is planning to prescribe opioids for postoperative pain control.
Patients > 18 years old undergoing elective hand surgery (bone/joint) for which the surgeon is planning to prescribe opioids for postoperative pain control.
Patients > 18 years old undergoing elective hand surgery (bone/joint) for which the surgeon is planning to prescribe opioids for postoperative pain control.
Outcomes
Primary Outcome Measures
Morphine milliequivalents consumed in 2 weeks postoperatively
Total morphine mEq consumed in 2 weeks after surgery
Secondary Outcome Measures
Visual Analog Scale
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).
Patient satisfaction
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.
Proper disposal
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.
Full Information
NCT ID
NCT04625868
First Posted
July 3, 2020
Last Updated
September 8, 2021
Sponsor
Northwestern University
Collaborators
American Society for Surgery of the Hand
1. Study Identification
Unique Protocol Identification Number
NCT04625868
Brief Title
Effectiveness of a Preoperative Educational Video for Reducing Opioid Consumption After Hand Surgery
Official Title
Effectiveness of a Preoperative Educational Video for Reducing Opioid Consumption After Hand Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 29, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
American Society for Surgery of the Hand
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study seeks to determine if watching a preoperative educational video influences opioid consumption and proper disposal following elective hand surgery.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Hand Injuries and Disorders, Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Soft tissue surgery - preoperative video
Arm Type
Experimental
Arm Description
Patients > 18 years old undergoing elective hand surgery (soft tissue) for which the surgeon is planning to prescribe opioids for postoperative pain control.
Arm Title
Soft tissue surgery - no video
Arm Type
No Intervention
Arm Description
Patients > 18 years old undergoing elective hand surgery (soft tissue) for which the surgeon is planning to prescribe opioids for postoperative pain control.
Arm Title
Bone/joint surgery - preoperative video
Arm Type
Experimental
Arm Description
Patients > 18 years old undergoing elective hand surgery (bone/joint) for which the surgeon is planning to prescribe opioids for postoperative pain control.
Arm Title
Bone/joint surgery - no video
Arm Type
No Intervention
Arm Description
Patients > 18 years old undergoing elective hand surgery (bone/joint) for which the surgeon is planning to prescribe opioids for postoperative pain control.
Intervention Type
Other
Intervention Name(s)
Educational video
Intervention Description
Patients will watch a preoperative educational video on proper opioid use and disposal.
Primary Outcome Measure Information:
Title
Morphine milliequivalents consumed in 2 weeks postoperatively
Description
Total morphine mEq consumed in 2 weeks after surgery
Time Frame
2 weeks after surgery
Secondary Outcome Measure Information:
Title
Visual Analog Scale
Description
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).
Time Frame
2 weeks after surgery
Title
Patient satisfaction
Description
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.
Time Frame
7-10 days after surgery
Title
Proper disposal
Description
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.
Time Frame
2 weeks after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M. Kalainov, M.D.
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of a Preoperative Educational Video for Reducing Opioid Consumption After Hand Surgery
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