Postoperative PainNCT04277975
Liberal vs. Restricted Post-discharge Opioid Prescribing Following Midurethral Sling
A study testing Liberal post-discharge opioid prescribing and Restricted post-discharge opioid prescribing in people with Postoperative Pain and Opioid Use, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The specific objective of this proposal is to evaluate pain and opioid use following a midurethral sling (MUS) under two different opioid prescribing schemes. The central hypothesis is that, in spite of the fact that opioids are often routinely prescribed by many surgeons following this procedure, most patients do not… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Opioid Use
- What is being tested?
- Liberal post-discharge opioid prescribing and Restricted post-discharge opioid prescribing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 1 Jul 2022
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Scheduled to undergo isolated midurethral sling after evaluation and discussion with surgeon
- Consent to participate in this study
Who cannot join
- Pregnant or breast feeding
- Cognitively impaired women
- Pre-existing diagnosis of opioid use disorder
- Patients with chronic daily opioid use
- Prisoners
- Non-English speaking or inability to read, as a result of the need to read and report daily results in English
- Allergy to oral opioids used in this study (oxycodone)
- Significant contraindications (allergy, severe hepatic or renal compromise, or other medical conditions deemed by surgeon) to the use of both NSAIDs (ibuprofen, naproxen) and acetaminophen
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State College of Medicine
Hershey, Pennsylvania, 17033
About this study
Official title: A Randomized Trial of Liberal vs. Restricted Post-discharge Opioid Prescribing Following Midurethral Sling
The specific objective of this proposal is to evaluate pain and opioid use following a midurethral sling (MUS) under two different opioid prescribing schemes. The central hypothesis is that, in spite of the fact that opioids are often routinely prescribed by many surgeons following this procedure, most patients do not require them for pain control, and patients who are not prescribed postoperative will have similar pain scores and pain control satisfaction compared with patients who are routinely prescribed a standard amount of opioids for postoperative pain control.
Read the detailed description
The investigators have 3 specific aims:
Specific Aim #1: Compare patients' postoperative pain experience and satisfaction with pain control using two different opioid prescribing schemes.
The investigators' working hypothesis is that postoperative pain control and satisfaction will be non-inferior between patients routinely prescribed opioids vs. those not routinely prescribed opioids prior to surgery.
Participants will be asked to complete a pain diary and assessment of their pain control satisfaction postoperatively. Pain control will be assessed by Likert scores (0-10) and satisfaction with pain control will be queried using an integer scale of 0-5 using REDCap or paper survey for the first 7 days postoperatively.
Specific Aim #2: Examine the opioid use of patients following midurethral sling.
The investigators will test the hypothesis that most patients who undergo MUS do not use prescribed opioid regardless of prescription scheme.
Given the investigators' standard of care preoperative education, including detailed instruction on non-opioid related pain management, they will prospectively examine the use of opioids after MUS under two different opioid prescribing routines. Women who agree to participation will be randomized to either be discharged home from surgery with a standard opioid prescription vs. only prescribed opioids if requested. The amount of opioid used will be collected via REDCap or paper survey for the first 7 days postoperatively. Investigators will also assess the subsequent requests for opioid prescription (among those not routinely given opioid prescription at discharge) or refill (among those who are initially given a standard amount of opioid upon discharge).
Specific Aim #3: Predict postoperative pain and opioid use after MUS with a brief psychometric questionnaire.
The investigators will leverage brief psychometric survey instruments in combination with individual demographic and clinical factors to predict postoperative pain and opioid use following MUS. They will seek to identify patients at risk for higher opioid needs or other pain interventions preoperatively, with a view to target education, prevention, and interventions on this population.
The project is original in comparing current clinical prescribing patterns with restrictive opioid prescribing. It capitalizes on providers' new ability to electronically prescribe opioids for patients who require them after discharge from the hospital, thereby decreasing the potential impact on patients and providers if prescribed opioid is requested once the patient has been discharged. The proposed work is innovative, because it examines recently developed psychometric survey instruments to identify patients at risk of postoperative pain. At the completion of this project, it is the investigators' expectation that the combination of work proposed in aims 1 -3 will optimize prescribing of opioids following this common MUS procedure, reducing the potential for both excessive opioid use (and adverse sequelae) postoperatively as well as unused opioid for subsequent misuse.
- Conditions
- Postoperative Pain, Opioid Use
- Being tested
- Liberal post-discharge opioid prescribing, Restricted post-discharge opioid prescribing
- Keywords
- midurethral sling, opioid
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liberal post-discharge opioid prescribingOther
Opioid prescribed all patients opioids 'in case they are needed' prior to surgery
Restricted post-discharge opioid prescribingOther
Opioid only if needed after discharge
| Study group | Role | What they receive |
|---|---|---|
| A: liberal post-discharge opioid prescribing | Active comparator | Standardized postoperative instructions on non-opioid pain control + liberal opioid prescription provided prior to surgery (standard prescription for opioid prescribed prior to surgery) Receives: Other: Restricted post-discharge opioid prescribing |
| B: restricted post-discharge opioid prescribing | Experimental | Standardized postoperative instructions on non-opioid pain control + opioid prescribed only 'as needed' after discharge Receives: Other: Liberal post-discharge opioid prescribing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score on postoperative day 1
Numeric score of pain at end of day (0-10 with 10 being the worst imaginable pain)
Measured: postoperative day 1
Secondary outcomes (4)
Satisfaction with pain control
scale of 1-5
Measured: postoperative day 7 daily scores will be assessed
The number of opioid pills used by those to whom they were prescribed
Count of opioid pills used after surgery
Measured: postoperative day 7 daily scores will be assessed
Calls for new opioid prescriptions or refills postoperatively
Phone calls or office visits to obtain pain medication prescription
Measured: postoperative day 7 daily outcome will be assessed
Psychometric survey and clinical/demographic factors associated with opioid use postoperatively
Validated survey scores
Measured: Upon enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start1 Jun 2020
- Primary completion3 Jan 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Long, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277975
- Sponsor's protocol ID
- STUDY13951
- Status last verified
- Jul 2022
- First submitted
- 18 Feb 2020
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
As-Sanie S, Till SR, Mowers EL, Lim CS, Skinner BD, Fritsch L, Tsodikov A, Dalton VK, Clauw DJ, Brummett CM. Opioid Prescribing Patterns, Patient Use, and Postoperative Pain After Hysterectomy for Benign Indications. Obstet Gynecol. 2017 Dec;130(6):1261-1268. doi: 10.1097/AOG.0000000000002344.
PubMed 29112660Howard R, Fry B, Gunaseelan V, Lee J, Waljee J, Brummett C, Campbell D Jr, Seese E, Englesbe M, Vu J. Association of Opioid Prescribing With Opioid Consumption After Surgery in Michigan. JAMA Surg. 2019 Jan 1;154(1):e184234. doi: 10.1001/jamasurg.2018.4234. Epub 2019 Jan 16.
PubMed 30422239Bartels K, Mayes LM, Dingmann C, Bullard KJ, Hopfer CJ, Binswanger IA. Opioid Use and Storage Patterns by Patients after Hospital Discharge following Surgery. PLoS One. 2016 Jan 29;11(1):e0147972. doi: 10.1371/journal.pone.0147972. eCollection 2016.
PubMed 26824844Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.
PubMed 28403427Bateman BT, Cole NM, Maeda A, Burns SM, Houle TT, Huybrechts KF, Clancy CR, Hopp SB, Ecker JL, Ende H, Grewe K, Raposo Corradini B, Schoenfeld RE, Sankar K, Day LJ, Harris L, Booth JL, Flood P, Bauer ME, Tsen LC, Landau R, Leffert LR. Patterns of Opioid Prescription and Use After Cesarean Delivery. Obstet Gynecol. 2017 Jul;130(1):29-35. doi: 10.1097/AOG.0000000000002093.
PubMed 28594763Hill MV, McMahon ML, Stucke RS, Barth RJ Jr. Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures. Ann Surg. 2017 Apr;265(4):709-714. doi: 10.1097/SLA.0000000000001993.
PubMed 27631771Morgan BM, Long JB, Boyd SS, Davies MF, Kunselman AR, Stetter CM, Andreae MH. Liberal vs. restricted opioid prescribing following midurethral sling dataset. Data Brief. 2023 Apr 12;48:109144. doi: 10.1016/j.dib.2023.109144. eCollection 2023 Jun.
PubMed 37383763Long JB, Morgan BM, Boyd SS, Davies MF, Kunselman AR, Stetter CM, Andreae MH. A randomized trial of standard vs restricted opioid prescribing following midurethral sling. Am J Obstet Gynecol. 2022 Aug;227(2):313.e1-313.e9. doi: 10.1016/j.ajog.2022.05.010. Epub 2022 May 10.
PubMed 35550371
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Liberal vs. Restricted Post-discharge Opioid Prescribing Following Midurethral Sling
- ClinicalTrials.gov ID
- NCT04277975
- Acronym / sponsor ID
- STUDY13951
- Conditions
- Postoperative Pain, Opioid Use
- Keywords
- midurethral sling, opioid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 3 Jan 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 20 Feb 2020 (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 specific objective of this proposal is to evaluate pain and opioid use following a midurethral sling (MUS) under two different opioid prescribing schemes. The central hypothesis is that, in spite of the fact that opioids are often routinely prescribed by many surgeons following this procedure, most patients do not require them for pain control, and patients who are not prescribed postoperative will have similar pain scores and pain control satisfaction compared with patients who are routinely prescribed a standard amount of opioids for postoperative pain control.
Detailed description
The investigators have 3 specific aims:
Specific Aim #1: Compare patients' postoperative pain experience and satisfaction with pain control using two different opioid prescribing schemes.
The investigators' working hypothesis is that postoperative pain control and satisfaction will be non-inferior between patients routinely prescribed opioids vs. those not routinely prescribed opioids prior to surgery.
Participants will be asked to complete a pain diary and assessment of their pain control satisfaction postoperatively. Pain control will be assessed by Likert scores (0-10) and satisfaction with pain control will be queried using an integer scale of 0-5 using REDCap or paper survey for the first 7 days postoperatively.
Specific Aim #2: Examine the opioid use of patients following midurethral sling.
The investigators will test the hypothesis that most patients who undergo MUS do not use prescribed opioid regardless of prescription scheme.
Given the investigators' standard of care preoperative education, including detailed instruction on non-opioid related pain management, they will prospectively examine the use of opioids after MUS under two different opioid prescribing routines. Women who agree to participation will be randomized to either be discharged home from surgery with a standard opioid prescription vs. only prescribed opioids if requested. The amount of opioid used will be collected via REDCap or paper survey for the first 7 days postoperatively. Investigators will also assess the subsequent requests for opioid prescription (among those not routinely given opioid prescription at discharge) or refill (among those who are initially given a standard amount of opioid upon discharge).
Specific Aim #3: Predict postoperative pain and opioid use after MUS with a brief psychometric questionnaire.
The investigators will leverage brief psychometric survey instruments in combination with individual demographic and clinical factors to predict postoperative pain and opioid use following MUS. They will seek to identify patients at risk for higher opioid needs or other pain interventions preoperatively, with a view to target education, prevention, and interventions on this population.
The project is original in comparing current clinical prescribing patterns with restrictive opioid prescribing. It capitalizes on providers' new ability to electronically prescribe opioids for patients who require them after discharge from the hospital, thereby decreasing the potential impact on patients and providers if prescribed opioid is requested once the patient has been discharged. The proposed work is innovative, because it examines recently developed psychometric survey instruments to identify patients at risk of postoperative pain. At the completion of this project, it is the investigators' expectation that the combination of work proposed in aims 1 -3 will optimize prescribing of opioids following this common MUS procedure, reducing the potential for both excessive opioid use (and adverse sequelae) postoperatively as well as unused opioid for subsequent misuse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: liberal post-discharge opioid prescribing | Active comparator | Other: Restricted post-discharge opioid prescribingStandardized postoperative instructions on non-opioid pain control + liberal opioid prescription provided prior to surgery (standard prescription for opioid prescribed prior to surgery) |
| B: restricted post-discharge opioid prescribing | Experimental | Other: Liberal post-discharge opioid prescribingStandardized postoperative instructions on non-opioid pain control + opioid prescribed only 'as needed' after discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled to undergo isolated midurethral sling after evaluation and discussion with surgeon
- Consent to participate in this study
Key exclusion criteria (8 listed)
- Pregnant or breast feeding
- Cognitively impaired women
- Pre-existing diagnosis of opioid use disorder
- Patients with chronic daily opioid use
- Prisoners
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 |
|---|---|---|
| Liberal post-discharge opioid prescribingOpioid prescribed all patients opioids 'in case they are needed' prior to surgery | Other | B: restricted post-discharge opioid prescribing |
| Restricted post-discharge opioid prescribingOpioid only if needed after discharge | Other | A: liberal post-discharge opioid prescribing |
Primary outcome
Pain score on postoperative day 1
Time frame: postoperative day 1
Numeric score of pain at end of day (0-10 with 10 being the worst imaginable pain)
4 secondary outcomes
Satisfaction with pain control
Time frame: postoperative day 7 daily scores will be assessed
The number of opioid pills used by those to whom they were prescribed
Time frame: postoperative day 7 daily scores will be assessed
Calls for new opioid prescriptions or refills postoperatively
Time frame: postoperative day 7 daily outcome will be assessed
Psychometric survey and clinical/demographic factors associated with opioid use postoperatively
Time frame: Upon enrollment
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 26 Jul 2022.
- Results publication: PubMed 29112660As-Sanie S, Till SR, Mowers EL, Lim CS, Skinner BD, Fritsch L, Tsodikov A, Dalton VK, Clauw DJ, Brummett CM. Opioid Prescribing Patterns, Patient Use, and Postoperative Pain After Hysterectomy for Benign Indications. Obstet Gynecol. 2017 Dec;130(6):1261-1268. doi: 10.1097/AOG.0000000000002344.
- Results publication: PubMed 30422239Howard R, Fry B, Gunaseelan V, Lee J, Waljee J, Brummett C, Campbell D Jr, Seese E, Englesbe M, Vu J. Association of Opioid Prescribing With Opioid Consumption After Surgery in Michigan. JAMA Surg. 2019 Jan 1;154(1):e184234. doi: 10.1001/jamasurg.2018.4234. Epub 2019 Jan 16.
- Results publication: PubMed 26824844Bartels K, Mayes LM, Dingmann C, Bullard KJ, Hopfer CJ, Binswanger IA. Opioid Use and Storage Patterns by Patients after Hospital Discharge following Surgery. PLoS One. 2016 Jan 29;11(1):e0147972. doi: 10.1371/journal.pone.0147972. eCollection 2016.
- Results publication: PubMed 28403427Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.
- Results publication: PubMed 28594763Bateman BT, Cole NM, Maeda A, Burns SM, Houle TT, Huybrechts KF, Clancy CR, Hopp SB, Ecker JL, Ende H, Grewe K, Raposo Corradini B, Schoenfeld RE, Sankar K, Day LJ, Harris L, Booth JL, Flood P, Bauer ME, Tsen LC, Landau R, Leffert LR. Patterns of Opioid Prescription and Use After Cesarean Delivery. Obstet Gynecol. 2017 Jul;130(1):29-35. doi: 10.1097/AOG.0000000000002093.
- Results publication: PubMed 27631771Hill MV, McMahon ML, Stucke RS, Barth RJ Jr. Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures. Ann Surg. 2017 Apr;265(4):709-714. doi: 10.1097/SLA.0000000000001993.
- Derived from this study: PubMed 37383763Morgan BM, Long JB, Boyd SS, Davies MF, Kunselman AR, Stetter CM, Andreae MH. Liberal vs. restricted opioid prescribing following midurethral sling dataset. Data Brief. 2023 Apr 12;48:109144. doi: 10.1016/j.dib.2023.109144. eCollection 2023 Jun.
- Derived from this study: PubMed 35550371Long JB, Morgan BM, Boyd SS, Davies MF, Kunselman AR, Stetter CM, Andreae MH. A randomized trial of standard vs restricted opioid prescribing following midurethral sling. Am J Obstet Gynecol. 2022 Aug;227(2):313.e1-313.e9. doi: 10.1016/j.ajog.2022.05.010. Epub 2022 May 10.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liberal post-discharge opioid prescribing and Restricted post-discharge opioid prescribing in people with Postoperative Pain and Opioid Use, run by Milton S. Hershey Medical Center 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 2 inclusion and 8 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 26 Jul 2022. 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?
Pain score on postoperative day 1 (time frame: postoperative day 1). 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 NCT04277975, which also lists 8 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 26 Jul 2022.