Reduced Opioid Prescription After Laparoscopic Hysterectomy

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05548582
• Other study ID #: IRB00345074
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Johns Hopkins University
• Contact: Marie-Claire Leaf, MD
• Phone: 4105020512
• Email: mleaf1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Misuse
• Opioid Use
• Opioid-Related Disorders
• Pain
• Pain, Postoperative

Intervention

Drug:
• OxyCODONE 5 mg Oral Tablet
No opioid prescription after laparoscopic hysterectomy
• Acetaminophen 500Mg Tab
Standard prescription
• Ibuprofen 600 mg
Standard prescription

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Satisfaction of pain control on postoperative day one	Overall satisfaction of pain control on postoperative day one (binary question - Yes/No)	1 day
Secondary	Satisfaction of pain control on postoperative day seven	Overall satisfaction of pain control on postoperative day seven (binary question - Yes/No)	7 days
Secondary	Mobility on postoperative day one	Satisfaction with mobility on postoperative day one (binary question - Yes/No)	1 day
Secondary	Mobility on postoperative day seven	Satisfaction with mobility on postoperative day seven (binary question - Yes/No)	7 days
Secondary	Total opioid consumption on postoperative day one	Total narcotic consumption by postoperative day one (in morphine milligram equivalent)	1 day
Secondary	Total opioid consumption on postoperative day seven	Total narcotic consumption by postoperative day seven (in morphine milligram equivalent)	7 days
Secondary	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)	1 day
Secondary	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)	7 days
Secondary	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)	7 days