Arthropathy of KneeNCT05593341
Opioid Education in Total Knee Arthroplasty
A study testing Opioid education in person and Opioid education via video in people with Arthropathy of Knee and Post Operative Pain, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
The goal of this experimental study is to compare different education intervention on opioid education for patients undergoing total knee arthroplasty. The specific research questions to address are: 1. Does perioperative education pathway reduce opioid refill requests? 2. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthropathy of Knee, Post Operative Pain, Opioid Use
- What is being tested?
- Opioid education in person and Opioid education via video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2022to 11 Sep 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between age 18 and 80 years old
- Undergoing primary total knee replacement surgery at Hospital for Special Surgery
- English speaking
Who cannot join
- History of chronic opioid use (continuous opioid use for 3 or more months)
- Opioid use within the past 3 months
- Contraindication to NSAIDs or acetaminophen
- Contraindication or allergy to opioids
- Contraindication to any study medications (i.e., fentanyl, ketamine, versed, acetaminophen, ketorolac, zofran, decadron)
- Discharge to rehab or skilled nursing facility (opioids are not prescribed by HSS providers)
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- Contraindication or refusal to receive neuraxial anesthesia or peripheralnerve blocks (PNB)
- Revision surgery
- Ambulatory surgery
- Patients who are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Effect of Perioperative Opioid Education on Outcomes After Total Knee Arthroplasty: A Randomized Study
The goal of this experimental study is to compare different education intervention on opioid education for patients undergoing total knee arthroplasty. The specific research questions to address are:
- Does perioperative education pathway reduce opioid refill requests?
- Is education pathway that focuses on pain management provided in-person and via video in repeated sessions more effective than current standard of care education consisting of a single exposure given as part of a broader preoperative presentation covering multiple topics?
- Is there a difference between education provided in-person vs video?
- Does perioperative education improve compliance with multimodal analgesia?
- Does perioperative education improve appropriate opioid storage?
- Does perioperative education improve appropriate opioid disposal?
Read more
Enrolled patients will be assigned at random to one of 3 study groups. Group 1 (control): Patients are referred to the hospital's standard 1-hour virtual patient education webinar prior to surgery.
Group 2 (in-person): Patients will receive two in-person education sessions (1st session before surgery and 2nd session after surgery). Patients will also receive portable document format (pdf) handouts about opioid and pain management.
Group 3 (video): Patients will receive two video education sessions (1st session before surgery and 2nd session after surgery). Patients will also receive pdf handouts about opioid and pain management.
Read the detailed description
Patients undergoing surgery are frequently unaware of how to properly use opioids for pain management which may result in poor compliance with pain regimens, worse pain control and functional outcomes, and improper storage and disposal. There is evidence that educational interventions in various formats may improve pain and promote proper opioid handling. In addition, multimodal analgesia has been shown to be effective in total joint arthroplasty, and setting appropriate expectations may reduce anxiety, postoperative recovery time, and post surgical acute pain.
The current education process at HSS involves patient referral to a virtual webinar which is optional. Pain topics are covered within a broader 50-minute presentation on numerous topics related to surgery. Information on pain topics may be difficult to process and retain because it is a single exposure that is combined with multiple unrelated topics, and there is no repetition or reference provided. The aim of this study is to explore how a comprehensive educational pathway focusing on aspects of pain control and proper opioid use with repeated sessions will affect outcomes after total knee arthroplasty by comparing three groups - 1) patients who attend the virtual webinar, 2) an in-person session with a portable document format (PDF), and 3) a video session with PDF.
- Being tested
- Opioid education in person, Opioid education via video
- Keywords
- Opioid Education
- Medical subject headings
- Pain, Postoperative, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid education in personOther
The presentation and handouts contain information regarding the following topics:
- Reviewing opioids and strategies for analgesia
- Defining and identifying opioids
- Goals for postoperative pain management and utilizing opioids to treat pain
- Alternative modes of treating pain
- Regional anesthesia/analgesia defined
- Side effects and risks of opioids
- Common side effects of opioids
- Risks of addiction, tolerance, dependence, opioid-induced hyperalgesia with long-term use
- Proper use and handling of opioids
- Safe practices when taking opioids
- Weaning off opioids
- Safe storage and disposal of opioids
Opioid education via videoOther
The video and handouts contain information regarding the following topics:
- Reviewing opioids and strategies for analgesia
- Defining and identifying opioids
- Goals for postoperative pain management and utilizing opioids to treat pain
- Alternative modes of treating pain
- Regional anesthesia/analgesia defined
- Side effects and risks of opioids
- Common side effects of opioids
- Risks of addiction, tolerance, dependence, opioid-induced hyperalgesia with long-term use
- Proper use and handling of opioids
- Safe practices when taking opioids
- Weaning off opioids
- Safe storage and disposal of opioids
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Patients are referred to the Hospital's standard 1-hour virtual patient education webinar prior to surgery. |
| In-person and PDF | Experimental | Patients will receive two in-person education sessions (1st session before surgery and 2nd session after surgery). Patients will also receive pdf handouts about opioids and pain management. Receives: Other: Opioid education in person |
| Video and PDF | Experimental | Patients will receive two video education sessions (1st session before surgery and 2nd session after surgery). Patients will also receive pdf handouts about opioids and pain management. Receives: Other: Opioid education via video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid refill at POD 30
Patients will be asked if they have refilled their opioid prescription and the number of opioid refills.
Measured: Post operative day (POD) 30
Opioid refill at POD 60
Patients will be asked if they have refilled their opioid prescription and the number of opioid refills.
Measured: Post operative day (POD) 60
Secondary outcomes (7)
Hospital length of stay
The total amount of time spent in-patient following their surgery.
Measured: From the time patient enters the post-anesthesia care unit (PACU entry) until the time patient is discharged from the hospital (discharge time), assessed up to 168 hours (1 week)
Patient's health and recovery status following their surgery
A survey titled: quality of recovery 15 (QoR15) is a patient- reported outcome measure measuring quality of recovery after surgery and anesthesia.
Each of the following question on the survey will be assessed on a 0-10 scale, with 0 meaning "none of the time" and 10 meaning "all of the time".
How have you been feeling in the last 24 hours?
- Able to breathe easily
- Been able to enjoy food
- Feeling rested
- Have had a good sleep
- Able to look after personal toilet and hygiene unaided
- Able to communicate with family or friends
- Getting support from hospital doctors and nurses
- Able to return to work or usual home activities
- Feeling comfortable and in control
- Having a feeling of general well-being Have you had any of the following in the last 24 hours?
- Moderate pain
- Severe pain
- Nausea or vomiting
- Feeling worried or anxious
- Feeling sad or depressed
Measured: Pre-operative (when patient is in the holding area being prepped for surgery), Post-operative day 1, Post-operative day 7, Post-operative day 14
Numerical Rating Scale
Patients are asked to report a number between 0 and 10 that best measures their pain intensity. Zero represents 'no pain at all' whereas 10 represents 'the worst pain ever possible'.
Measured: Post-operative day 0, Post-operative day 1, Post-operative day 7, Post-operative day 14
Opioid consumption
The amount of opioid consumption by the patient (in oral morphine equivalents).
Measured: Post-operative day 0, Post-operative day 1, Post-operative day 7, Post-operative day 14
Rates of compliance with multimodal regimen
Patients will keep "pain diary" to record use of each medication (acetaminophen, NSAIDs, and opioid). Compliance will be defined as the percentage of prescribed medication (acetaminophen or NSAID) that is actually taken.
Measured: Post-operative day 1, Post-operative day 7, Post-operative day 14
Rates of proper opioid storage
Patients will be asked to report how they are storing their opioids (i.e., stored "locked and hidden").
Measured: Post-operative day 7
Rates of proper opioid disposal
Patients will be asked to report how they are disposing of their unused opioids (i.e., reporting they dispose using one of the accepted proper disposal methods).
Measured: Post-operative day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start27 Sep 2022
- Primary completion11 Sep 2023
- Study completion11 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Arthropathy of KneeStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bradley H Lee, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593341
- Sponsor's protocol ID
- 2022-1286
- Status last verified
- Dec 2024
- First submitted
- 30 Sep 2022
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available to other researchers.
Publications
Lee BH, Wu CL. Educating Patients Regarding Pain Management and Safe Opioid Use After Surgery: A Narrative Review. Anesth Analg. 2020 Mar;130(3):574-581. doi: 10.1213/ANE.0000000000004436.
PubMed 31567320Syed UAM, Aleem AW, Wowkanech C, Weekes D, Freedman M, Tjoumakaris F, Abboud JA, Austin LS. Neer Award 2018: the effect of preoperative education on opioid consumption in patients undergoing arthroscopic rotator cuff repair: a prospective, randomized clinical trial. J Shoulder Elbow Surg. 2018 Jun;27(6):962-967. doi: 10.1016/j.jse.2018.02.039. Epub 2018 Mar 26.
PubMed 29599038Egan KG, De Souza M, Muenks E, Nazir N, Korentager R. Opioid Consumption Following Breast Surgery Decreases with a Brief Educational Intervention: A Randomized, Controlled Trial. Ann Surg Oncol. 2020 Sep;27(9):3156-3162. doi: 10.1245/s10434-020-08432-7. Epub 2020 Apr 13.
PubMed 32285282Horn A, Kaneshiro K, Tsui BCH. Preemptive and Preventive Pain Psychoeducation and Its Potential Application as a Multimodal Perioperative Pain Control Option: A Systematic Review. Anesth Analg. 2020 Mar;130(3):559-573. doi: 10.1213/ANE.0000000000004319.
PubMed 31335400Memtsoudis SG, Poeran J, Zubizarreta N, Cozowicz C, Morwald EE, Mariano ER, Mazumdar M. Association of Multimodal Pain Management Strategies with Perioperative Outcomes and Resource Utilization: A Population-based Study. Anesthesiology. 2018 May;128(5):891-902. doi: 10.1097/ALN.0000000000002132.
PubMed 29498951Stepan JG, Sacks HA, Verret CI, Wessel LE, Kumar K, Fufa DT. Standardized Perioperative Patient Education Decreases Opioid Use after Hand Surgery: A Randomized Controlled Trial. Plast Reconstr Surg. 2021 Feb 1;147(2):409-418. doi: 10.1097/PRS.0000000000007574.
PubMed 33235041Nahhas CR, Hannon CP, Yang J, Gerlinger TL, Nam D, Della Valle CJ. Education Increases Disposal of Unused Opioids After Total Joint Arthroplasty: A Cluster-Randomized Controlled Trial. J Bone Joint Surg Am. 2020 Jun 3;102(11):953-960. doi: 10.2106/JBJS.19.01166.
PubMed 32251139Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.
PubMed 16079372Sheetz M, Puglisi A, Trentalange M, Reichel J, Chalmers B, Gonzalez Della Valle A, Sideris A, Lee BH. Comparing modalities of opioid education in patients undergoing total knee arthroplasty: a randomized pilot trial. Reg Anesth Pain Med. 2026 Jan 5;51(1):60-68. doi: 10.1136/rapm-2024-105701.
PubMed 39327049
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Opioid Education on Outcomes After Total Knee Arthroplasty: A Randomized Study
- ClinicalTrials.gov ID
- NCT05593341
- Acronym / sponsor ID
- 2022-1286
- Keywords
- Opioid Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 11 Sep 2023 (actual)
- Study completion
- 11 Sep 2023 (actual)
- First posted
- 25 Oct 2022 (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.
The goal of this experimental study is to compare different education intervention on opioid education for patients undergoing total knee arthroplasty. The specific research questions to address are:
- Does perioperative education pathway reduce opioid refill requests?
- Is education pathway that focuses on pain management provided in-person and via video in repeated sessions more effective than current standard of care education consisting of a single exposure given as part of a broader preoperative presentation covering multiple topics?
- Is there a difference between education provided in-person vs video?
- Does perioperative education improve compliance with multimodal analgesia?
- Does perioperative education improve appropriate opioid storage?
- Does perioperative education improve appropriate opioid disposal?
Enrolled patients will be assigned at random to one of 3 study groups. Group 1 (control): Patients are referred to the hospital's standard 1-hour virtual patient education webinar prior to surgery.
Group 2 (in-person): Patients will receive two in-person education sessions (1st session before surgery and 2nd session after surgery). Patients will also receive portable document format (pdf) handouts about opioid and pain management.
Group 3 (video): Patients will receive two video education sessions (1st session before surgery and 2nd session after surgery). Patients will also receive pdf handouts about opioid and pain management.
Detailed description
Patients undergoing surgery are frequently unaware of how to properly use opioids for pain management which may result in poor compliance with pain regimens, worse pain control and functional outcomes, and improper storage and disposal. There is evidence that educational interventions in various formats may improve pain and promote proper opioid handling. In addition, multimodal analgesia has been shown to be effective in total joint arthroplasty, and setting appropriate expectations may reduce anxiety, postoperative recovery time, and post surgical acute pain.
The current education process at HSS involves patient referral to a virtual webinar which is optional. Pain topics are covered within a broader 50-minute presentation on numerous topics related to surgery. Information on pain topics may be difficult to process and retain because it is a single exposure that is combined with multiple unrelated topics, and there is no repetition or reference provided. The aim of this study is to explore how a comprehensive educational pathway focusing on aspects of pain control and proper opioid use with repeated sessions will affect outcomes after total knee arthroplasty by comparing three groups - 1) patients who attend the virtual webinar, 2) an in-person session with a portable document format (PDF), and 3) a video session with PDF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients are referred to the Hospital's standard 1-hour virtual patient education webinar prior to surgery. |
| In-person and PDF | Experimental | Other: Opioid education in personPatients will receive two in-person education sessions (1st session before surgery and 2nd session after surgery). Patients will also receive pdf handouts about opioids and pain management. |
| Video and PDF | Experimental | Other: Opioid education via videoPatients will receive two video education sessions (1st session before surgery and 2nd session after surgery). Patients will also receive pdf handouts about opioids and pain management. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between age 18 and 80 years old
- Undergoing primary total knee replacement surgery at Hospital for Special Surgery
- English speaking
Key exclusion criteria (10 listed)
- History of chronic opioid use (continuous opioid use for 3 or more months)
- Opioid use within the past 3 months
- Contraindication to NSAIDs or acetaminophen
- Contraindication or allergy to opioids
- Contraindication to any study medications (i.e., fentanyl, ketamine, versed, acetaminophen, ketorolac, zofran, decadron)
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 |
|---|---|---|
| Opioid education in personThe presentation and handouts contain information regarding the following topics: * Reviewing opioids and strategies for analgesia * Defining and identifying opioids * Goals for postoperative pain management and utilizing opioids to treat pain * Alternative modes of treating pain * Regional anesthesia/analgesia defined * Side effects and risks of opioids * Common side effects of opioids * Risks of addiction, tolerance, dependence, opioid-induced hyperalgesia with long-term use * Proper use and handling of opioids * Safe practices when taking opioids * Weaning off opioids * Safe storage and disposal of opioids | Other | In-person and PDF |
| Opioid education via videoThe video and handouts contain information regarding the following topics: * Reviewing opioids and strategies for analgesia * Defining and identifying opioids * Goals for postoperative pain management and utilizing opioids to treat pain * Alternative modes of treating pain * Regional anesthesia/analgesia defined * Side effects and risks of opioids * Common side effects of opioids * Risks of addiction, tolerance, dependence, opioid-induced hyperalgesia with long-term use * Proper use and handling of opioids * Safe practices when taking opioids * Weaning off opioids * Safe storage and disposal of opioids | Other | Video and PDF |
Primary outcome
Opioid refill at POD 30
Time frame: Post operative day (POD) 30
Patients will be asked if they have refilled their opioid prescription and the number of opioid refills.
Opioid refill at POD 60
Time frame: Post operative day (POD) 60
Patients will be asked if they have refilled their opioid prescription and the number of opioid refills.
7 secondary outcomes
Hospital length of stay
Time frame: From the time patient enters the post-anesthesia care unit (PACU entry) until the time patient is discharged from the hospital (discharge time), assessed up to 168 hours (1 week)
Patient's health and recovery status following their surgery
Time frame: Pre-operative (when patient is in the holding area being prepped for surgery), Post-operative day 1, Post-operative day 7, Post-operative day 14
Numerical Rating Scale
Time frame: Post-operative day 0, Post-operative day 1, Post-operative day 7, Post-operative day 14
Opioid consumption
Time frame: Post-operative day 0, Post-operative day 1, Post-operative day 7, Post-operative day 14
Rates of compliance with multimodal regimen
Time frame: Post-operative day 1, Post-operative day 7, Post-operative day 14
Rates of proper opioid storage
Time frame: Post-operative day 7
Rates of proper opioid disposal
Time frame: Post-operative day 21
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 27 Dec 2024.
- Results publication: PubMed 31567320Lee BH, Wu CL. Educating Patients Regarding Pain Management and Safe Opioid Use After Surgery: A Narrative Review. Anesth Analg. 2020 Mar;130(3):574-581. doi: 10.1213/ANE.0000000000004436.
- Results publication: PubMed 29599038Syed UAM, Aleem AW, Wowkanech C, Weekes D, Freedman M, Tjoumakaris F, Abboud JA, Austin LS. Neer Award 2018: the effect of preoperative education on opioid consumption in patients undergoing arthroscopic rotator cuff repair: a prospective, randomized clinical trial. J Shoulder Elbow Surg. 2018 Jun;27(6):962-967. doi: 10.1016/j.jse.2018.02.039. Epub 2018 Mar 26.
- Results publication: PubMed 32285282Egan KG, De Souza M, Muenks E, Nazir N, Korentager R. Opioid Consumption Following Breast Surgery Decreases with a Brief Educational Intervention: A Randomized, Controlled Trial. Ann Surg Oncol. 2020 Sep;27(9):3156-3162. doi: 10.1245/s10434-020-08432-7. Epub 2020 Apr 13.
- Results publication: PubMed 31335400Horn A, Kaneshiro K, Tsui BCH. Preemptive and Preventive Pain Psychoeducation and Its Potential Application as a Multimodal Perioperative Pain Control Option: A Systematic Review. Anesth Analg. 2020 Mar;130(3):559-573. doi: 10.1213/ANE.0000000000004319.
- Results publication: PubMed 29498951Memtsoudis SG, Poeran J, Zubizarreta N, Cozowicz C, Morwald EE, Mariano ER, Mazumdar M. Association of Multimodal Pain Management Strategies with Perioperative Outcomes and Resource Utilization: A Population-based Study. Anesthesiology. 2018 May;128(5):891-902. doi: 10.1097/ALN.0000000000002132.
- Results publication: PubMed 33235041Stepan JG, Sacks HA, Verret CI, Wessel LE, Kumar K, Fufa DT. Standardized Perioperative Patient Education Decreases Opioid Use after Hand Surgery: A Randomized Controlled Trial. Plast Reconstr Surg. 2021 Feb 1;147(2):409-418. doi: 10.1097/PRS.0000000000007574.
- Results publication: PubMed 32251139Nahhas CR, Hannon CP, Yang J, Gerlinger TL, Nam D, Della Valle CJ. Education Increases Disposal of Unused Opioids After Total Joint Arthroplasty: A Cluster-Randomized Controlled Trial. J Bone Joint Surg Am. 2020 Jun 3;102(11):953-960. doi: 10.2106/JBJS.19.01166.
- Results publication: PubMed 16079372Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.
- Derived from this study: PubMed 39327049Sheetz M, Puglisi A, Trentalange M, Reichel J, Chalmers B, Gonzalez Della Valle A, Sideris A, Lee BH. Comparing modalities of opioid education in patients undergoing total knee arthroplasty: a randomized pilot trial. Reg Anesth Pain Med. 2026 Jan 5;51(1):60-68. doi: 10.1136/rapm-2024-105701.
- Individual participant dataSharing planned: No. There is no plan to make IPD available to other researchers.
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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.
Bradley H Lee, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid education in person and Opioid education via video in people with Arthropathy of Knee and Post Operative Pain, run by Hospital for Special Surgery, New York 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 3 inclusion and 10 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 27 Dec 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. 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?
Opioid refill at POD 30 (time frame: Post operative day (POD) 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05593341, which also lists 9 linked publications.
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 27 Dec 2024.