Liberal vs. Restricted Post-discharge Opioid Prescribing Following Midurethral Sling

July 25, 2022 updated by: Jaime Long, Milton S. Hershey Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: A: liberal post-discharge opioid prescribing
Standardized postoperative instructions on non-opioid pain control + liberal opioid prescription provided prior to surgery (standard prescription for opioid prescribed prior to surgery)
Other: Restricted post-discharge opioid prescribing
Opioid only if needed after discharge
EXPERIMENTAL: B: restricted post-discharge opioid prescribing
Standardized postoperative instructions on non-opioid pain control + opioid prescribed only 'as needed' after discharge
Other: Liberal post-discharge opioid prescribing
Opioid prescribed all patients opioids 'in case they are needed' prior to surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
postoperative day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with pain control
Time Frame: postoperative day 7 daily scores will be assessed
scale of 1-5
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
Count of opioid pills used after surgery
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
Phone calls or office visits to obtain pain medication prescription
postoperative day 7 daily outcome will be assessed
Psychometric survey and clinical/demographic factors associated with opioid use postoperatively
Time Frame: Upon enrollment
Validated survey scores
Upon enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2020

Primary Completion (ACTUAL)

January 3, 2022

Study Completion (ACTUAL)

July 1, 2022

Study Registration Dates

First Submitted

February 18, 2020

First Submitted That Met QC Criteria

February 18, 2020

First Posted (ACTUAL)

February 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 25, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY13951

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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