Post Operative PainNCT05571072
Opioid Use After Urogynecologic Procedures: Using a Predictive Calculator
A study testing Opioid calculator and Standard opioid prescription in people with Post Operative Pain and Opioid Use, run by David Sheyn at 1 site in United States.
Trial summary
The purpose of this study is to determine if the investigators can precisely predict how much pain medication the subjects will need after surgery using a special calculator that was developed for this purpose. Read more about this study
- Who is it for?
- Ages 18 to 89 years, women only
- Conditions the study is for
- Post Operative Pain, Opioid Use, Prolapse Genital
- What is being tested?
- Opioid calculator and Standard opioid prescription
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2023to 17 Feb 2024
- 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 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-89
- Able to provide informed consent
- Patients undergoing any of below urogynecologic procedures
- Included urogynecologic procedures:
- Sacrocolpopexy - robotic or laparoscopic
- With or without hysterectomy
Show all 26Show fewer
- With or without salpingo-oophorectomy
- With or without anterior colporrhaphy
- With or without posterior colporrhaphy/perineorrhaphy
- With or without midurethral sling
- Sacrospinous ligament fixation
- With or without hysterectomy
- With or without salpingo-oophorectomy
- With or without anterior colporrhaphy
- With or without posterior colporrhaphy/perineorrhaphy
- With or without midurethral sling
- Uterosacral ligament suspension - robotic, laparoscopic, or vaginal
- With or without hysterectomy
- With or without salpingo-oophorectomy
- With or without anterior colporrhaphy
- With or without posterior colporrhaphy/perineorrhaphy
- With or without midurethral sling
- Colpocleisis
- Lefort colpocleisis
- Complete colpectomy with colpocleisis
- Isolated anterior and/or posterior colporrhaphy
Who cannot join
- Non-English speakers
- pre-operative diagnosis of cancer
- scheduled for any concurrent non-urogynecologic procedure (ex: abdominoplasty)
- <18 years or >89 years of age
- unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
The purpose of this study is to determine if the investigators can precisely predict how much pain medication the subjects will need after surgery using a special calculator that was developed for this purpose.
- Conditions
- Post Operative Pain, Opioid Use, Prolapse Genital
- Being tested
- Opioid calculator, Standard opioid prescription
- Keywords
- post operative pain, opioid use, urogynecologic surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid calculatorOther
Our research group previously created an Opioid calculator that can be used to predict the number of opioids needed post-operatively based on patient health history and characteristics.
Standard opioid prescriptionOther
Patients will receive prescription for post-operative opioids based on what the attending surgeon usually provides.
| Study group | Role | What they receive |
|---|---|---|
| Standard Opioid Prescription | Active comparator | Patients will be given a prescription for opioid pain medication to use for acute postoperative pain as would be typical for the attending surgeon performing the surgery. Receives: Other: Standard opioid prescription |
| Opioid Calculator Prescription | Experimental | Patients will be a given a prescription for opioid pain medication based on the opioid calculator. Receives: Other: Opioid calculator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain scores measured by team-created pain questionnaires
Pain questionnaire is a 2 question survey that ask patients to rate pain on scale of 0 (no pain) to 10 (worst pain) immediately post-op and current. Baseline will be calculated by asking patient's expected post-op pain score.
Measured: baseline, 1 week post-op, 2 weeks post-op
Secondary outcomes (2)
Change in satisfaction scores measured by team-created questionnaire
Questionnaire is a 1 question survey that ask patients to rate their satisfaction with their pain control on scale of 0 (totally unsatisfied) to 10 (totally satisfied) immediately post-op and current.
Measured: 1 week post-op, 2 weeks post-op
Change in number of opioid tablets remaining measured by team-created questionnaire
Patients will be asked the number of tablets remaining from their opioid prescriptions.
Measured: 1 week post-op, 2 weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start2 Jan 2023
- Primary completion17 Feb 2024
- Study completion17 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies 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
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Sheyn
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Sheyn, University Hospitals Cleveland Medical Center
- Investigators
- David Sheyn, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571072
- Sponsor's protocol ID
- STUDY20221287
- Status last verified
- Jun 2024
- First submitted
- 4 Oct 2022
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bauer HH, Schlussel MA, Hoffberg EA, Palm KM, Rhodes SP, Wherley SD, Le Neveu M, Sears SB, Rustia GM, Hijaz AK, Mahajan ST, Sammarco AG, Sheyn D. Personalized Prediction of Opioid Demand After Surgery for Pelvic Organ Prolapse: A Randomized Controlled Trial. Obstet Gynecol. 2025 Jun 26;146(2):285-292. doi: 10.1097/AOG.0000000000005969.
PubMed 40570353
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Use After Urogynecologic Procedures: Using a Predictive Calculator
- ClinicalTrials.gov ID
- NCT05571072
- Acronym / sponsor ID
- STUDY20221287
- Conditions
- Post Operative Pain, Opioid Use, Prolapse Genital
- Keywords
- post operative pain, opioid use, urogynecologic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- David SheynUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 17 Feb 2024 (actual)
- Study completion
- 17 Feb 2024 (actual)
- First posted
- 7 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 purpose of this study is to determine if the investigators can precisely predict how much pain medication the subjects will need after surgery using a special calculator that was developed for this purpose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Opioid Prescription | Active comparator | Other: Standard opioid prescriptionPatients will be given a prescription for opioid pain medication to use for acute postoperative pain as would be typical for the attending surgeon performing the surgery. |
| Opioid Calculator Prescription | Experimental | Other: Opioid calculatorPatients will be a given a prescription for opioid pain medication based on the opioid calculator. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Age 18-89
- Able to provide informed consent
- Patients undergoing any of below urogynecologic procedures
- Sacrocolpopexy - robotic or laparoscopic
- Sacrospinous ligament fixation
Key exclusion criteria (5 listed)
- Non-English speakers
- pre-operative diagnosis of cancer
- scheduled for any concurrent non-urogynecologic procedure (ex: abdominoplasty)
- <18 years or >89 years of age
- unable to provide informed consent
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 calculatorOur research group previously created an Opioid calculator that can be used to predict the number of opioids needed post-operatively based on patient health history and characteristics. | Other | Opioid Calculator Prescription |
| Standard opioid prescriptionPatients will receive prescription for post-operative opioids based on what the attending surgeon usually provides. | Other | Standard Opioid Prescription |
Primary outcome
Change in pain scores measured by team-created pain questionnaires
Time frame: baseline, 1 week post-op, 2 weeks post-op
Pain questionnaire is a 2 question survey that ask patients to rate pain on scale of 0 (no pain) to 10 (worst pain) immediately post-op and current. Baseline will be calculated by asking patient's expected post-op pain score.
2 secondary outcomes
Change in satisfaction scores measured by team-created questionnaire
Time frame: 1 week post-op, 2 weeks post-op
Change in number of opioid tablets remaining measured by team-created questionnaire
Time frame: 1 week post-op, 2 weeks post-op
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 21 Jun 2024.
- Derived from this study: PubMed 40570353Bauer HH, Schlussel MA, Hoffberg EA, Palm KM, Rhodes SP, Wherley SD, Le Neveu M, Sears SB, Rustia GM, Hijaz AK, Mahajan ST, Sammarco AG, Sheyn D. Personalized Prediction of Opioid Demand After Surgery for Pelvic Organ Prolapse: A Randomized Controlled Trial. Obstet Gynecol. 2025 Jun 26;146(2):285-292. doi: 10.1097/AOG.0000000000005969.
- 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 Sheyn, MD principal investigator
University Hospitals Cleveland Medical Center
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 calculator and Standard opioid prescription in people with Post Operative Pain and Opioid Use, run by David Sheyn 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 26 inclusion and 5 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 Jun 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?
Change in pain scores measured by team-created pain questionnaires (time frame: baseline, 1 week post-op, 2 weeks post-op). 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 NCT05571072, 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 21 Jun 2024.