NCT05548582

Brief Summary

Given the nationwide epidemic of opioid use and abuse (in part due to over prescription), this study aims at addressing the need for opioid prescription after laparoscopic hysterectomy.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress84%
Jan 2023Dec 2026

First Submitted

Initial submission to the registry

September 16, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

January 12, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

4 years

First QC Date

September 16, 2022

Last Update Submit

January 9, 2026

Conditions

Pain, PostoperativeOpioid MisuseOpioid UsePain

Outcome Measures

Primary Outcomes (2)

  • Pain score on post-operative day one

    Numeric pain score on post-operative day one: patient reported pain using the Likert pain scale from 0 to 10

    1 day

  • Pain score on post-operative day seven

    Numeric pain score on post-operative day seven: patient reported pain using the Likert pain scale from 0 to 10

    7 days

Secondary Outcomes (9)

  • Satisfaction of pain control on postoperative day one

    1 day

  • Satisfaction of pain control on postoperative day seven

    7 days

  • Mobility on postoperative day one

    1 day

  • Mobility on postoperative day seven

    7 days

  • Total opioid consumption on postoperative day one

    1 day

  • +4 more secondary outcomes

Study Arms (2)

Post-operative opioid prescription

OTHER

Ibuprofen 600mg every 6 hours x 48 hours then as needed (total 30 tablets). If allergy or contraindication to ibuprofen, then will receive Meloxicam 15mg daily x 48 hours then as needed Acetaminophen 500mg every 6 hours x 48 hours then as needed (total 30 tablets) Oxycodone 5mg every 4 hours as needed (total 12 tablets)

Drug: OxyCODONE 5 mg Oral TabletDrug: Acetaminophen 500 mg TabDrug: Ibuprofen 600 mg

No Opioid prescription

ACTIVE COMPARATOR

Ibuprofen 600mg every 6 hours x 48 hours then as needed (total 30 tablets). If allergy or contraindication to ibuprofen, will receive Meloxicam 15mg daily x 48 hours then as needed Acetaminophen 500mg every 6 hours x 48 hours then as needed (total 30 tablets)

Drug: Acetaminophen 500 mg TabDrug: Ibuprofen 600 mg

Interventions

OxyCODONE 5 mg Oral TabletDRUG

No opioid prescription after laparoscopic hysterectomy

Post-operative opioid prescription
Acetaminophen 500 mg TabDRUG

Standard prescription

No Opioid prescriptionPost-operative opioid prescription
Ibuprofen 600 mgDRUG

Standard prescription

No Opioid prescriptionPost-operative opioid prescription

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over the age of 18 undergoing outpatient laparoscopic (conventional or robotic) hysterectomy for benign indications

You may not qualify if:

  • Allergy or other contraindication to the prescribed medications such as acetaminophen, ibuprofen, or oxycodone
  • Known opioid use or abuse (defined as reported use or treatment for abuse within the last 3 months)
  • Chronic pain patients
  • Conversion to laparotomy
  • Malignancy as the indication for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Pain, PostoperativeOpioid-Related DisordersPain

Interventions

OxycodoneTabletsAcetaminophenIbuprofen

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsDosage FormsPharmaceutical PreparationsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPhenylpropionatesAcids, CarbocyclicCarboxylic Acids

Study Officials

  • Mostafa Borahay

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2022

First Posted

September 21, 2022

Study Start

January 12, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 12, 2026

Record last verified: 2026-01

Locations

US(1)