GynecologyPhase 2/3NCT03805386
Patient-Directed Postoperative Opioid Prescribing for Gynecologic Surgery
A Phase 2/3 study testing Physician directed opioid prescribing and Patient directed opioid prescribing in people with Gynecology and Surgery, run by Mayo Clinic at 1 site in United States.
Trial summary
We would like to evaluate and optimize opioid prescribing after minimally invasive hysterectomy. Currently, our standard prescribing is 150 oral morphine equivalents. However, recent studies show that half of the opioids prescribed are not used. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecology, Surgery, Opioid Use
- What is being tested?
- Physician directed opioid prescribing and Patient directed opioid prescribing
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2019to 15 Apr 2020
- Phase
- Phase 2/3
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients >18 years old
- Ability to provide informed consent
- Planned minimally invasive hysterectomy with the Department of Gynecology o Concomitant minimally invasive surgeries performed by Gynecology will be allowed
Who cannot join
- Non-English speaking
- Combined surgical cases with other surgical departments
- Planned laparotomy
- Surgery planned to last >4 hours
- Postoperative hospitalization planned for >7 days
- Planned use of oral opioids other than oxycodone postoperatively
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- Pre-existing chronic pain conditions including: chronic pelvic pain, migraines, temporomandibular joint dysfunction syndrome, fibromyalgia, and interstitial cystitis
- Preoperative diagnosis of pelvic pain
- Chronic preoperative opioid use
- History of or current diagnosis of narcotic or alcohol dependence
- o Screening question asked at preoperative appointment: Have you or are you currently dependent on narcotic medications or alcohol?
- Desire for more opioids than standard therapy
- Postoperative decision of surgeon to prescribed more than standard therapy
- Allergy or contraindication to taking opioids, ibuprofen, or acetaminophen
Trial locations and contacts
1 site in 1 country.
About this study
We would like to evaluate and optimize opioid prescribing after minimally invasive hysterectomy. Currently, our standard prescribing is 150 oral morphine equivalents. However, recent studies show that half of the opioids prescribed are not used. We would like to include the patient in the decision making of the opioid prescribing.
We have designed a randomized controlled trial to prescribe standard (150 oral morphine equivalents) or patient directed (less than or equal to 150 oral morphine equivalents) for pain control.
Read more
We hypothesize that with patient input, there will be a higher utilization of the opioids prescribed. Also, we anticipate a lower number of opioids used overall.
This study will help us optimize opioid prescribe and evaluate whether patient input can help in this important measure.
Read the detailed description
There is an emphasis in patient centered care in medicine and part of this effort has evaluated the success of shared decision making in the care of the patient. Currently, there is strong research and clinical emphasis trying to determine how, as surgeons, we can assist in minimizing the misuse of opioid medications. Several studies have shown significant over-prescribing and under-utilizing of the pain medications that are prescribed to patients after surgery. One such study by As-Sanie et al showed that about half of medications were utilized for pain after surgery, with typically 200 oral morphine equivalents prescribed.
A recent prospective cohort study by Prabhu et al showed that shared decision making in the prescription of narcotic pain medications after cesarean section decreased opioid use without impacting patient satisfaction.
We propose a randomized controlled trial evaluating the impact of shared decision making in the prescribing of pain medications after minimally invasive gynecologic surgery. For adult female patients who are undergoing minimally invasive hysterectomy, we will randomize them to either standard care or patient directed treatment. Our standard arm will receive 150 oral morphine equivalents, or 30 tablets of oxycodone, whereas our patient directed arm will receive a prescription with as many pills is determined after discussion with the patient.
We hope to contribute to identifying the optimized opioid prescription for post surgical patients.
- Conditions
- Gynecology, Surgery, Opioid Use
- Being tested
- Physician directed opioid prescribing, Patient directed opioid prescribing
- Keywords
- patient directed postoperative opioid prescribing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician directed opioid prescribingDrug
Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.
Patient directed opioid prescribingDrug
Oxycodone 5mg amount ranging from 0 tablets to as much as 30 tablets as described in the standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Subjects will be prescribed the standard amount of opioids that are typically prescribed by our practice after surgery. Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided. Receives: Drug: Physician directed opioid prescribing |
| Patient Directed Care | Experimental | Subject directed arm will be prescribed the number of opioids that the patient decides to be appropriate after discussion with the surgeon. This can be as low as 0 pills and as much as 30 pills as described in the standard care. Receives: Drug: Patient directed opioid prescribing |
What is being measured
The primary outcome is the main question the study is designed to answer.
# of Opioid Pills Consumed
Percent utilization of opioids consumed (consumed/prescribed)
Measured: 6 weeks postop
Secondary outcomes (2)
Opioid Pills Prescribed
Number of opioids prescribed
Measured: preoperative visit
Patient Satisfaction
Patients were asked if they were satisfied with the # of oxycodone pills prescribed.
Measured: 6 weeks post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start15 Jan 2019
- Primary completion15 Apr 2020
- Study completion15 Apr 2020
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 GynecologyStudies of the same condition, open and under way.
- More trials run by Mayo 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johnny Yi, Mayo Clinic
- Investigators
- Johnny Yi, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805386
- Sponsor's protocol ID
- 18-004216
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 2019
- Last updated
- 21 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Directed Postoperative Opioid Prescribing for Gynecologic Surgery
- ClinicalTrials.gov ID
- NCT03805386
- Acronym / sponsor ID
- 18-004216
- Conditions
- Gynecology, Surgery, Opioid Use
- Keywords
- patient directed postoperative opioid prescribing
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 15 Jan 2019 (actual)
- Results
- Posted 21 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We would like to evaluate and optimize opioid prescribing after minimally invasive hysterectomy. Currently, our standard prescribing is 150 oral morphine equivalents. However, recent studies show that half of the opioids prescribed are not used. We would like to include the patient in the decision making of the opioid prescribing.
We have designed a randomized controlled trial to prescribe standard (150 oral morphine equivalents) or patient directed (less than or equal to 150 oral morphine equivalents) for pain control.
We hypothesize that with patient input, there will be a higher utilization of the opioids prescribed. Also, we anticipate a lower number of opioids used overall.
This study will help us optimize opioid prescribe and evaluate whether patient input can help in this important measure.
Detailed description
There is an emphasis in patient centered care in medicine and part of this effort has evaluated the success of shared decision making in the care of the patient. Currently, there is strong research and clinical emphasis trying to determine how, as surgeons, we can assist in minimizing the misuse of opioid medications. Several studies have shown significant over-prescribing and under-utilizing of the pain medications that are prescribed to patients after surgery. One such study by As-Sanie et al showed that about half of medications were utilized for pain after surgery, with typically 200 oral morphine equivalents prescribed.
A recent prospective cohort study by Prabhu et al showed that shared decision making in the prescription of narcotic pain medications after cesarean section decreased opioid use without impacting patient satisfaction.
We propose a randomized controlled trial evaluating the impact of shared decision making in the prescribing of pain medications after minimally invasive gynecologic surgery. For adult female patients who are undergoing minimally invasive hysterectomy, we will randomize them to either standard care or patient directed treatment. Our standard arm will receive 150 oral morphine equivalents, or 30 tablets of oxycodone, whereas our patient directed arm will receive a prescription with as many pills is determined after discussion with the patient.
We hope to contribute to identifying the optimized opioid prescription for post surgical patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Drug: Physician directed opioid prescribingSubjects will be prescribed the standard amount of opioids that are typically prescribed by our practice after surgery. Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided. |
| Patient Directed Care | Experimental | Drug: Patient directed opioid prescribingSubject directed arm will be prescribed the number of opioids that the patient decides to be appropriate after discussion with the surgeon. This can be as low as 0 pills and as much as 30 pills as described in the standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients >18 years old
- Ability to provide informed consent
- Planned minimally invasive hysterectomy with the Department of Gynecology o Concomitant minimally invasive surgeries performed by Gynecology will be allowed
Key exclusion criteria (14 listed)
- Non-English speaking
- Combined surgical cases with other surgical departments
- Planned laparotomy
- Surgery planned to last >4 hours
- Postoperative hospitalization planned for >7 days
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 |
|---|---|---|
| Physician directed opioid prescribingOxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided. | Drug | Standard of Care |
| Patient directed opioid prescribingOxycodone 5mg amount ranging from 0 tablets to as much as 30 tablets as described in the standard of care. | Drug | Patient Directed Care |
Primary outcome
# of Opioid Pills Consumed
Time frame: 6 weeks postop
Percent utilization of opioids consumed (consumed/prescribed)
2 secondary outcomes
Opioid Pills Prescribed
Time frame: preoperative visit
Patient Satisfaction
Time frame: 6 weeks post-operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Johnny Yi principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Physician directed opioid prescribing and Patient directed opioid prescribing in people with Gynecology and Surgery, run by Mayo 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 3 inclusion and 14 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 21 Feb 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2021). 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?
# of Opioid Pills Consumed (time frame: 6 weeks postop). 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 21 Feb 2021.