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Reduced Opioid Prescription After Laparoscopic Hysterectomy

Primary Purpose

Pain, Postoperative, Opioid Misuse, Opioid Use

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OxyCODONE 5 mg Oral Tablet
Acetaminophen 500Mg Tab
Ibuprofen 600 mg
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • Overnight admissions
  • Malignancy as the indication for surgery

Sites / Locations

  • Johns Hopkins HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Post-operative opioid prescription

No Opioid prescription

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Satisfaction of pain control on postoperative day one
Overall satisfaction of pain control on postoperative day one (binary question - Yes/No)
Satisfaction of pain control on postoperative day seven
Overall satisfaction of pain control on postoperative day seven (binary question - Yes/No)
Mobility on postoperative day one
Satisfaction with mobility on postoperative day one (binary question - Yes/No)
Mobility on postoperative day seven
Satisfaction with mobility on postoperative day seven (binary question - Yes/No)
Total opioid consumption on postoperative day one
Total narcotic consumption by postoperative day one (in morphine milligram equivalent)
Total opioid consumption on postoperative day seven
Total narcotic consumption by postoperative day seven (in morphine milligram equivalent)
Opioid related side effects on postoperative day one
Presence of opioid related side effects such as nausea, vomiting, constipation, dizziness, abdominal distention, and itchiness on postoperative day one (binary question - Yes/No)
Opioid related side effects on postoperative day seven
Presence of opioid related side effects such as nausea, vomiting, constipation, dizziness, abdominal distention, and itchiness on postoperative day seven (binary question - Yes/No)
Unplanned calls/visits
Unplanned visits to the emergency room or clinic and unexpected patient initiated phone call related to pain control postoperatively (binary question - Yes/No)

Full Information

First Posted
September 16, 2022
Last Updated
January 12, 2023
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT05548582
Brief Title
Reduced Opioid Prescription After Laparoscopic Hysterectomy
Official Title
A Randomized Controlled Trial to Study Reduced Opioid Prescription After Laparoscopic Hysterectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Currently, there is a nationwide epidemic of opioid abuse and overdose deaths. One source of excess opioids is overprescribing in the postoperative period. Given the increasing opioid abuse and over-prescription post-operatively, an effort must be made to determine whether non-opioid multimodal medications are adequate in treating postoperative pain after laparoscopic hysterectomy and would not increase the need for additional prescriptions or unscheduled patient contacts. This study aims to find the optimal prescriptions for pain after laparoscopic hysterectomy in an attempt to eliminate opioid use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Opioid Misuse, Opioid Use, Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Post-operative opioid prescription
Arm Type
Other
Arm Description
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)
Arm Title
No Opioid prescription
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
OxyCODONE 5 mg Oral Tablet
Intervention Description
No opioid prescription after laparoscopic hysterectomy
Intervention Type
Drug
Intervention Name(s)
Acetaminophen 500Mg Tab
Intervention Description
Standard prescription
Intervention Type
Drug
Intervention Name(s)
Ibuprofen 600 mg
Intervention Description
Standard prescription
Primary Outcome Measure Information:
Title
Pain score on post-operative day one
Description
Numeric pain score on post-operative day one: patient reported pain using the Likert pain scale from 0 to 10
Time Frame
1 day
Title
Pain score on post-operative day seven
Description
Numeric pain score on post-operative day seven: patient reported pain using the Likert pain scale from 0 to 10
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Satisfaction of pain control on postoperative day one
Description
Overall satisfaction of pain control on postoperative day one (binary question - Yes/No)
Time Frame
1 day
Title
Satisfaction of pain control on postoperative day seven
Description
Overall satisfaction of pain control on postoperative day seven (binary question - Yes/No)
Time Frame
7 days
Title
Mobility on postoperative day one
Description
Satisfaction with mobility on postoperative day one (binary question - Yes/No)
Time Frame
1 day
Title
Mobility on postoperative day seven
Description
Satisfaction with mobility on postoperative day seven (binary question - Yes/No)
Time Frame
7 days
Title
Total opioid consumption on postoperative day one
Description
Total narcotic consumption by postoperative day one (in morphine milligram equivalent)
Time Frame
1 day
Title
Total opioid consumption on postoperative day seven
Description
Total narcotic consumption by postoperative day seven (in morphine milligram equivalent)
Time Frame
7 days
Title
Opioid related side effects on postoperative day one
Description
Presence of opioid related side effects such as nausea, vomiting, constipation, dizziness, abdominal distention, and itchiness on postoperative day one (binary question - Yes/No)
Time Frame
1 day
Title
Opioid related side effects on postoperative day seven
Description
Presence of opioid related side effects such as nausea, vomiting, constipation, dizziness, abdominal distention, and itchiness on postoperative day seven (binary question - Yes/No)
Time Frame
7 days
Title
Unplanned calls/visits
Description
Unplanned visits to the emergency room or clinic and unexpected patient initiated phone call related to pain control postoperatively (binary question - Yes/No)
Time Frame
7 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients over the age of 18 undergoing outpatient laparoscopic (conventional or robotic) hysterectomy for benign indications Exclusion Criteria: 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 Overnight admissions Malignancy as the indication for surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Claire Leaf, MD
Phone
4105020512
Email
mleaf1@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mostafa Borahay
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Claire Leaf
Email
mleaf1@jhmi.edu

12. IPD Sharing Statement

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Reduced Opioid Prescription After Laparoscopic Hysterectomy

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