Reduced Opioid Prescription After Laparoscopic Hysterectomy

Sponsor

Johns Hopkins University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05548582

Collaborator

(none)

120

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative Opioid Misuse Opioid Use Pain	Drug: OxyCODONE 5 mg Oral Tablet Drug: Acetaminophen 500Mg Tab Drug: Ibuprofen 600 mg	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

A Randomized Controlled Trial to Study Reduced Opioid Prescription After Laparoscopic Hysterectomy

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Post-operative opioid prescription 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 Tablet No opioid prescription after laparoscopic hysterectomy Drug: Acetaminophen 500Mg Tab Standard prescription Drug: Ibuprofen 600 mg Standard prescription
Active Comparator: No Opioid prescription 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 500Mg Tab Standard prescription Drug: Ibuprofen 600 mg Standard prescription

Arm

Intervention/Treatment

Other: Post-operative opioid prescription

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 Tablet

No opioid prescription after laparoscopic hysterectomy

Drug: Acetaminophen 500Mg Tab

Standard prescription

Drug: Ibuprofen 600 mg

Standard prescription

Active Comparator: No Opioid prescription

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 500Mg Tab

Standard prescription

Drug: Ibuprofen 600 mg

Standard prescription

Outcome Measures

Primary Outcome Measures

Pain score on post-operative day one [1 day]
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 [7 days]
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 [1 day]
Overall satisfaction of pain control on postoperative day one (binary question - Yes/No)
Satisfaction of pain control on postoperative day seven [7 days]
Overall satisfaction of pain control on postoperative day seven (binary question - Yes/No)
Mobility on postoperative day one [1 day]
Satisfaction with mobility on postoperative day one (binary question - Yes/No)
Mobility on postoperative day seven [7 days]
Satisfaction with mobility on postoperative day seven (binary question - Yes/No)
Total opioid consumption on postoperative day one [1 day]
Total narcotic consumption by postoperative day one (in morphine milligram equivalent)
Total opioid consumption on postoperative day seven [7 days]
Total narcotic consumption by postoperative day seven (in morphine milligram equivalent)
Opioid related side effects on postoperative day one [1 day]
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 [7 days]
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 [7 days]
Unplanned visits to the emergency room or clinic and unexpected patient initiated phone call related to pain control postoperatively (binary question - Yes/No)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator: Mostafa Borahay, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT05548582

Other Study ID Numbers:

IRB00345074

First Posted:

Sep 21, 2022

Last Update Posted:

Sep 21, 2022

Last Verified:

Sep 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Opioid-Related Disorders

Acetaminophen

Ibuprofen

Oxycodone

Study Results

No Results Posted as of Sep 21, 2022