Postoperative PainNCT04970069
Preoperative Education
A study testing Video on analgesic education and Video on general perioperative education in people with Postoperative Pain, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The investigators will evaluate the effect of preoperative education on postoperative opioid. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Video on analgesic education and Video on general perioperative education
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,057 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2021to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Preoperative Education on Postoperative Opioid Consumption
The investigators will evaluate the effect of preoperative education on postoperative opioid.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Video on analgesic education, Video on general perioperative education
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video on analgesic educationOther
A four minute video informing the patient about opioids.
Video on general perioperative educationOther
A four minute video informing the patient about general perioperative process.
| Study group | Role | What they receive |
|---|---|---|
| Analgesic education | Active comparator | Not described Receives: Other: Video on analgesic education |
| General perioperative education | Placebo comparator | Not described Receives: Other: Video on general perioperative education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption
Opioid consumption (morphine milligrams equivalent) during the initial 72 hours after surgery.
Measured: 72 hours after surgery
Secondary outcomes (2)
Time-weighted Average Pain Scores
Time-weighted average of pain scores obtained from electronic medical records. Pain scores were measured using the numeric rating scale ranging from 0-10, with 0 indicating the lowest pain (better) and 10 the highest pain (worse). Pain scores were recorded approximately every 15 minutes in the post-anesthesia care unit and then every 4 hours in the ward.
Measured: 72 hours after surgery, or until discharge, whichever was earlier
Satisfaction With Post Operative Pain Management
Patient satisfaction measured using Likert scale 0-10 with 0 meaning not satisfied and 10 meaning completely satisfied.
Measured: 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start25 Jul 2021
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,057 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alparslan Turan, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970069
- Sponsor's protocol ID
- 21-626
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2021
- Last updated
- 25 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Education on Postoperative Opioid Consumption
- ClinicalTrials.gov ID
- NCT04970069
- Acronym / sponsor ID
- 21-626
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,057 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 25 Jul 2021 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 21 Jul 2021 (actual)
- Results
- Posted 25 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will evaluate the effect of preoperative education on postoperative opioid.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Analgesic education | Active comparator | Other: Video on analgesic education |
| General perioperative education | Placebo comparator | Other: Video on general perioperative education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Video on analgesic educationA four minute video informing the patient about opioids. | Other | Analgesic education |
| Video on general perioperative educationA four minute video informing the patient about general perioperative process. | Other | General perioperative education |
Primary outcome
Opioid Consumption
Time frame: 72 hours after surgery
Opioid consumption (morphine milligrams equivalent) during the initial 72 hours after surgery.
2 secondary outcomes
Time-weighted Average Pain Scores
Time frame: 72 hours after surgery, or until discharge, whichever was earlier
Satisfaction With Post Operative Pain Management
Time frame: 3 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Alparslan Turan, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video on analgesic education and Video on general perioperative education in people with Postoperative Pain, run by The Cleveland Clinic 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 7 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 25 Jul 2024. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 25 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Opioid Consumption (time frame: 72 hours 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 25 Jul 2024.