Liberal vs. Restricted Post-discharge Opioid Prescribing Following Midurethral Sling
Primary Purpose
Postoperative Pain, Opioid Use
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Liberal post-discharge opioid prescribing
Restricted post-discharge opioid prescribing
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring midurethral sling, opioid
Eligibility Criteria
Inclusion Criteria:
- Scheduled to undergo isolated midurethral sling after evaluation and discussion with surgeon
- Consent to participate in this study
Exclusion Criteria:
- 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
Sites / Locations
- Penn State College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
A: liberal post-discharge opioid prescribing
B: restricted post-discharge opioid prescribing
Arm Description
Standardized postoperative instructions on non-opioid pain control + liberal opioid prescription provided prior to surgery (standard prescription for opioid prescribed prior to surgery)
Standardized postoperative instructions on non-opioid pain control + opioid prescribed only 'as needed' after discharge
Outcomes
Primary Outcome Measures
Pain score on postoperative day 1
Numeric score of pain at end of day (0-10 with 10 being the worst imaginable pain)
Secondary Outcome Measures
Satisfaction with pain control
scale of 1-5
The number of opioid pills used by those to whom they were prescribed
Count of opioid pills used after surgery
Calls for new opioid prescriptions or refills postoperatively
Phone calls or office visits to obtain pain medication prescription
Psychometric survey and clinical/demographic factors associated with opioid use postoperatively
Validated survey scores
Full Information
NCT ID
NCT04277975
First Posted
February 18, 2020
Last Updated
July 25, 2022
Sponsor
Milton S. Hershey Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04277975
Brief Title
Liberal vs. Restricted Post-discharge Opioid Prescribing Following Midurethral Sling
Official Title
A Randomized Trial of Liberal vs. Restricted Post-discharge Opioid Prescribing Following Midurethral Sling
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
January 3, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Opioid Use
Keywords
midurethral sling, opioid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A: liberal post-discharge opioid prescribing
Arm Type
Active Comparator
Arm Description
Standardized postoperative instructions on non-opioid pain control + liberal opioid prescription provided prior to surgery (standard prescription for opioid prescribed prior to surgery)
Arm Title
B: restricted post-discharge opioid prescribing
Arm Type
Experimental
Arm Description
Standardized postoperative instructions on non-opioid pain control + opioid prescribed only 'as needed' after discharge
Intervention Type
Other
Intervention Name(s)
Liberal post-discharge opioid prescribing
Intervention Description
Opioid prescribed all patients opioids 'in case they are needed' prior to surgery
Intervention Type
Other
Intervention Name(s)
Restricted post-discharge opioid prescribing
Intervention Description
Opioid only if needed after discharge
Primary Outcome Measure Information:
Title
Pain score on postoperative day 1
Description
Numeric score of pain at end of day (0-10 with 10 being the worst imaginable pain)
Time Frame
postoperative day 1
Secondary Outcome Measure Information:
Title
Satisfaction with pain control
Description
scale of 1-5
Time Frame
postoperative day 7 daily scores will be assessed
Title
The number of opioid pills used by those to whom they were prescribed
Description
Count of opioid pills used after surgery
Time Frame
postoperative day 7 daily scores will be assessed
Title
Calls for new opioid prescriptions or refills postoperatively
Description
Phone calls or office visits to obtain pain medication prescription
Time Frame
postoperative day 7 daily outcome will be assessed
Title
Psychometric survey and clinical/demographic factors associated with opioid use postoperatively
Description
Validated survey scores
Time Frame
Upon enrollment
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Scheduled to undergo isolated midurethral sling after evaluation and discussion with surgeon
Consent to participate in this study
Exclusion Criteria:
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
Facility Information:
Facility Name
Penn State College of Medicine
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29112660
Citation
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.
Results Reference
result
PubMed Identifier
30422239
Citation
Howard 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. Erratum In: JAMA Surg. 2019 Apr 1;154(4):368.
Results Reference
result
PubMed Identifier
26824844
Citation
Bartels 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 Reference
result
PubMed Identifier
28403427
Citation
Brummett 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. Erratum In: JAMA Surg. 2019 Mar 1;154(3):272.
Results Reference
result
PubMed Identifier
28594763
Citation
Bateman 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 Reference
result
PubMed Identifier
27631771
Citation
Hill 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.
Results Reference
result
PubMed Identifier
35550371
Citation
Long 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.
Results Reference
derived
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Liberal vs. Restricted Post-discharge Opioid Prescribing Following Midurethral Sling
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