Abuses Over-The-Counter/Prescription MedicationsREPAIRNCT03726476
Expectations and Pain Control Advancement In surgeRy: The REPAIR Trial
A study testing Patient centered pre-op education and routine preop education in people with Abuses Over-The-Counter/Prescription Medications and Pain, Postoperative, run by University of New Mexico at 2 sites in United States.
Trial summary
This is a randomized control trial that aims to evaluate whether patient-centered education, compared to routine education, decreases narcotic consumption without interfering with return to physical activity following hospital discharge. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abuses Over-The-Counter/Prescription Medications, Pain, Postoperative, Opioid Use
- What is being tested?
- Patient centered pre-op education and routine preop education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Sep 2019to 6 Dec 2021
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are ≥ 18 years of age
- English or Spanish speaking
- Patient scheduled for pelvic floor surgery
Who cannot join
- Unable to speak English or Spanish
- Using long acting opioids (e.g. MS Contin, Fentanyl patch)
- Primary or Pain Healthcare Provider recommends against study participation (eg. If the patient has a history of opioid use disorder or other confounding problems, we will contact the Primary Care Provider or Pain Healthcare Provider for their recommendations regarding study participation)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UNMH Women's Care Clinic
Albuquerque, New Mexico, 87112
UNM Sandoval Regional Medical Center
Rio Rancho, New Mexico, 87144
About this study
Official title: Randomized Trial on Expectations and Pain Control Advancement In surgeRy: The REPAIR Trial
This is a randomized control trial that aims to evaluate whether patient-centered education, compared to routine education, decreases narcotic consumption without interfering with return to physical activity following hospital discharge. In addition, it will test whether patient-centered education decreases the quantity of narcotics prescribed and/or increases patient satisfaction and preparedness.
Read the detailed description
Opioid use disorder is a national health emergency. Opioid prescribing practices to treat post-operative pain have contributed to the problem. This study seeks to explore the effects of changing pre-operative education \& increasing patient input regarding post-operative receipt of opioids. The study will explore the effects that change in pre-operative education may have on post-operative opioid consumption juxtaposed upon return to physical activity using a randomized trial design. Women undergoing pelvic floor reconstructive surgery will be randomized to either (i) standard pre-operative education (ii) modified, patient-centered pre-operative education. The investigators will monitor both post-operative opioid consumption and return to physical activity. The investigators hypothesize that investigation of patient's post-operative pain experiences and their inclusion in the educational and the shared decision-making process will likely decrease post-operative narcotic use without affecting return to function. Our long-term goal is to develop a pragmatic and balanced approach to address pain concerns, decreasing the medical community's contribution to the opioid epidemic.
- Conditions
- Abuses Over-The-Counter/Prescription Medications, Pain, Postoperative, Opioid Use, Physical Activity, Patient Dependence on
- Being tested
- Patient centered pre-op education, routine preop education
- Medical subject headings
- Pain, Postoperative, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient centered pre-op educationBehavioural
To implement a patient centered education intervention to evaluate post-op narcotic use.
routine preop educationBehavioural
To implement routine patient education intervention to evaluate post-op narcotic use.
| Study group | Role | What they receive |
|---|---|---|
| Patient Centered pre-op education | Experimental | Patient centered pre-operative education and patient centered post-operative care. Receives: Behavioral: Patient centered pre-op education |
| Routine Pre-op education | Active comparator | Participants will receive routine pre-operative education and post-op will receive a standardized number of narcotics Receives: Behavioral: routine preop education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Use at Approximately Two Weeks Post-op
Morphine milligram equivalents at the two weeks post-op
Measured: 2 weeks
Secondary outcomes (1)
Opioid Use at Approximately Six to Eight Weeks Post-op
Morphine milligram equivalents at the six to eight weeks post-op
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start10 Sep 2019
- Primary completion6 Dec 2021
- Study completion6 Dec 2021
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abuses Over-The-Counter/Prescription MedicationsStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter C Jeppson, University of New Mexico
- Investigators
- Yuko Komesu, MD, Study director, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726476
- Sponsor's protocol ID
- 18-262
- Acronym
- REPAIR
- Status last verified
- Feb 2024
- First submitted
- 13 Jul 2018
- Last updated
- 18 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Serna-Gallegos TR, Komesu YM, Dunivan GC, Meriwether KV, Ninivaggio CS, Petersen TR, Jeppson PC. Randomized Trial on Expectations and Pain Control Advancement in Surgery: The REPAIR Study. Urogynecology (Phila). 2024 Jan 1;30(1):7-16. doi: 10.1097/SPV.0000000000001387. Epub 2023 Jun 27.
PubMed 37428883
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial on Expectations and Pain Control Advancement In surgeRy: The REPAIR Trial
- ClinicalTrials.gov ID
- NCT03726476
- Acronym / sponsor ID
- REPAIR / 18-262
- Conditions
- Abuses Over-The-Counter/Prescription Medications, Pain, Postoperative, Opioid Use, Physical Activity, Patient Dependence on
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 6 Dec 2021 (actual)
- Study completion
- 6 Dec 2021 (actual)
- First posted
- 31 Oct 2018 (actual)
- Results
- Posted 18 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized control trial that aims to evaluate whether patient-centered education, compared to routine education, decreases narcotic consumption without interfering with return to physical activity following hospital discharge. In addition, it will test whether patient-centered education decreases the quantity of narcotics prescribed and/or increases patient satisfaction and preparedness.
Detailed description
Opioid use disorder is a national health emergency. Opioid prescribing practices to treat post-operative pain have contributed to the problem. This study seeks to explore the effects of changing pre-operative education \& increasing patient input regarding post-operative receipt of opioids. The study will explore the effects that change in pre-operative education may have on post-operative opioid consumption juxtaposed upon return to physical activity using a randomized trial design. Women undergoing pelvic floor reconstructive surgery will be randomized to either (i) standard pre-operative education (ii) modified, patient-centered pre-operative education. The investigators will monitor both post-operative opioid consumption and return to physical activity. The investigators hypothesize that investigation of patient's post-operative pain experiences and their inclusion in the educational and the shared decision-making process will likely decrease post-operative narcotic use without affecting return to function. Our long-term goal is to develop a pragmatic and balanced approach to address pain concerns, decreasing the medical community's contribution to the opioid epidemic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Centered pre-op education | Experimental | Behavioral: Patient centered pre-op educationPatient centered pre-operative education and patient centered post-operative care. |
| Routine Pre-op education | Active comparator | Behavioral: routine preop educationParticipants will receive routine pre-operative education and post-op will receive a standardized number of narcotics |
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)
- Subjects are ≥ 18 years of age
- English or Spanish speaking
- Patient scheduled for pelvic floor surgery
Key exclusion criteria (3 listed)
- Unable to speak English or Spanish
- Using long acting opioids (e.g. MS Contin, Fentanyl patch)
- Primary or Pain Healthcare Provider recommends against study participation (eg. If the patient has a history of opioid use disorder or other confounding problems, we will contact the Primary Care Provider or Pain Healthcare Provider for their recommendations regarding study participation)
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 |
|---|---|---|
| Patient centered pre-op educationTo implement a patient centered education intervention to evaluate post-op narcotic use. | Behavioural | Patient Centered pre-op education |
| routine preop educationTo implement routine patient education intervention to evaluate post-op narcotic use. | Behavioural | Routine Pre-op education |
Primary outcome
Opioid Use at Approximately Two Weeks Post-op
Time frame: 2 weeks
Morphine milligram equivalents at the two weeks post-op
1 secondary outcome
Opioid Use at Approximately Six to Eight Weeks Post-op
Time frame: 6-8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37428883Serna-Gallegos TR, Komesu YM, Dunivan GC, Meriwether KV, Ninivaggio CS, Petersen TR, Jeppson PC. Randomized Trial on Expectations and Pain Control Advancement in Surgery: The REPAIR Study. Urogynecology (Phila). 2024 Jan 1;30(1):7-16. doi: 10.1097/SPV.0000000000001387. Epub 2023 Jun 27.
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.
Yuko Komesu, MD study director
University of New Mexico
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient centered pre-op education and routine preop education in people with Abuses Over-The-Counter/Prescription Medications and Pain, Postoperative, run by University of New Mexico at 2 sites 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 3 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 18 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 2 sites 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?
Yes. Results are posted in the registry (first posted 18 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 Use at Approximately Two Weeks Post-op (time frame: 2 weeks). 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 NCT03726476, which also lists 1 linked publication.
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 18 Jul 2024.