NCT04277975

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

1.6 years

First QC Date

February 18, 2020

Last Update Submit

July 25, 2022

Conditions

Postoperative PainOpioid Use

Keywords

midurethral slingopioid

Outcome Measures

Primary Outcomes (1)

  • Pain score on postoperative day 1

    Numeric score of pain at end of day (0-10 with 10 being the worst imaginable pain)

    postoperative day 1

Secondary Outcomes (4)

  • Satisfaction with pain control

    postoperative day 7 daily scores will be assessed

  • The number of opioid pills used by those to whom they were prescribed

    postoperative day 7 daily scores will be assessed

  • Calls for new opioid prescriptions or refills postoperatively

    postoperative day 7 daily outcome will be assessed

  • Psychometric survey and clinical/demographic factors associated with opioid use postoperatively

    Upon enrollment

Study Arms (2)

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)

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

Other: Liberal post-discharge opioid prescribing

Interventions

Liberal post-discharge opioid prescribingOTHER

Opioid prescribed all patients opioids 'in case they are needed' prior to surgery

B: restricted post-discharge opioid prescribing
Restricted post-discharge opioid prescribingOTHER

Opioid only if needed after discharge

A: liberal post-discharge opioid prescribing

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled to undergo isolated midurethral sling after evaluation and discussion with surgeon
  • Consent to participate in this study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (8)

  • 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.

    PMID: 29112660RESULT

  • 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.

    PMID: 30422239RESULT

  • 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.

    PMID: 26824844RESULT

  • 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.

    PMID: 28403427RESULT

  • 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.

    PMID: 28594763RESULT

  • 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.

    PMID: 27631771RESULT

  • Morgan 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.

    PMID: 37383763DERIVED

  • 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.

    PMID: 35550371DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

February 18, 2020

First Posted

February 20, 2020

Study Start

June 1, 2020

Primary Completion

January 3, 2022

Study Completion

July 1, 2022

Last Updated

July 26, 2022

Record last verified: 2022-07

Locations

US(1)