Opioid UseNCT04625868
Effectiveness of a Preoperative Educational Video for Reducing Opioid Consumption After Hand Surgery
A study testing Educational video in people with Opioid Use and Hand Injuries and Disorders, run by Northwestern University at 1 site in United States.
Trial summary
This study seeks to determine if watching a preoperative educational video influences opioid consumption and proper disposal following elective hand surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Hand Injuries and Disorders, Surgery
- What is being tested?
- Educational video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2020to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing elective hand surgery
- surgeon is planning to prescribe opioids for postoperative pain control
Who cannot join
- emergent surgery
- surgeon not planning to prescribe opioids for postoperative pain control
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
This study seeks to determine if watching a preoperative educational video influences opioid consumption and proper disposal following elective hand surgery.
Read the 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.
- Conditions
- Opioid Use, Hand Injuries and Disorders, Surgery
- Being tested
- Educational video
- Medical subject headings
- Hand Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational videoOther
Patients will watch a preoperative educational video on proper opioid use and disposal.
| Study group | Role | What they receive |
|---|---|---|
| Soft tissue surgery - preoperative video | Experimental | Patients > 18 years old undergoing elective hand surgery (soft tissue) for which the surgeon is planning to prescribe opioids for postoperative pain control. Receives: Other: Educational video |
| Soft tissue surgery - no video | No intervention | Patients > 18 years old undergoing elective hand surgery (soft tissue) for which the surgeon is planning to prescribe opioids for postoperative pain control. |
| Bone/joint surgery - preoperative video | Experimental | Patients > 18 years old undergoing elective hand surgery (bone/joint) for which the surgeon is planning to prescribe opioids for postoperative pain control. Receives: Other: Educational video |
| Bone/joint surgery - no video | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Morphine milliequivalents consumed in 2 weeks postoperatively
Total morphine mEq consumed in 2 weeks after surgery
Measured: 2 weeks after surgery
Secondary outcomes (3)
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).
Measured: 2 weeks after surgery
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.
Measured: 7-10 days after surgery
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.
Measured: 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start29 May 2020
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Surgery of the Hand
- Responsible party
- Principal investigator, David Kalainov, Northwestern University
- Investigators
- David M. Kalainov, M.D., Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625868
- Sponsor's protocol ID
- 00211034
- Status last verified
- Sep 2021
- First submitted
- 3 Jul 2020
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Preoperative Educational Video for Reducing Opioid Consumption After Hand Surgery
- ClinicalTrials.gov ID
- NCT04625868
- Acronym / sponsor ID
- 00211034
- Conditions
- Opioid Use, Hand Injuries and Disorders, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- American Society for Surgery of the Hand
- Study start
- 29 May 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 12 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Soft tissue surgery - preoperative video | Experimental | Other: Educational videoPatients > 18 years old undergoing elective hand surgery (soft tissue) for which the surgeon is planning to prescribe opioids for postoperative pain control. |
| Soft tissue surgery - no video | No intervention | –Patients > 18 years old undergoing elective hand surgery (soft tissue) for which the surgeon is planning to prescribe opioids for postoperative pain control. |
| Bone/joint surgery - preoperative video | Experimental | Other: Educational videoPatients > 18 years old undergoing elective hand surgery (bone/joint) for which the surgeon is planning to prescribe opioids for postoperative pain control. |
| Bone/joint surgery - no video | No intervention | –Patients > 18 years old undergoing elective hand surgery (bone/joint) for which the surgeon is planning to prescribe opioids for postoperative pain control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- undergoing elective hand surgery
- surgeon is planning to prescribe opioids for postoperative pain control
Key exclusion criteria (2 listed)
- emergent surgery
- surgeon not planning to prescribe opioids for postoperative pain control
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational videoPatients will watch a preoperative educational video on proper opioid use and disposal. | Other | Bone/joint surgery - preoperative video, Soft tissue surgery - preoperative video |
Primary outcome
Morphine milliequivalents consumed in 2 weeks postoperatively
Time frame: 2 weeks after surgery
Total morphine mEq consumed in 2 weeks after surgery
3 secondary outcomes
Visual Analog Scale
Time frame: 2 weeks after surgery
Patient satisfaction
Time frame: 7-10 days after surgery
Proper disposal
Time frame: 2 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David M. Kalainov, M.D. principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational video in people with Opioid Use and Hand Injuries and Disorders, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine milliequivalents consumed in 2 weeks postoperatively (time frame: 2 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2021.