Reduced Opioid Prescription After Laparoscopic Hysterectomy

Not Applicable

Active, not recruiting

• Conditions: Pain, Postoperative; Opioid Misuse; Opioid Use; Pain
• Interventions: Drug: OxyCODONE 5 mg Oral Tablet; Drug: Acetaminophen 500 mg Tab; Drug: Ibuprofen 600 mg

• Registration Number: NCT05548582
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study First Submitted: 2022-09-16
• Study First Submitted QC: 2022-09-16
• Study First Posted: 2022-09-21
• Study Start: 2023-01-12
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-09
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 120

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
• Malignancy as the indication for surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Post-operative opioid prescription	OxyCODONE 5 mg Oral Tablet	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)
Post-operative opioid prescription	Ibuprofen 600 mg	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)
Post-operative opioid prescription	Acetaminophen 500 mg Tab	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)
No Opioid prescription	Ibuprofen 600 mg	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)
No Opioid prescription	Acetaminophen 500 mg Tab	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)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Mobility on postoperative day seven	7 days	Satisfaction with mobility on postoperative day seven (binary question - Yes/No)
Satisfaction of pain control on postoperative day one	1 day	Overall satisfaction of pain control on postoperative day one (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)
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)
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)

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States