A Randomized Controlled Trial to Study Reduced Opioid Prescription After Laparoscopic Hysterectomy
Overview
- Phase
- Not Applicable
- Intervention
- Acetaminophen 500 mg Tab
- Conditions
- Pain, Postoperative
- Sponsor
- Johns Hopkins University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Pain score on post-operative day one
- Status
- Active, not recruiting
- Last Updated
- 3 months ago
Overview
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.
Investigators
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
- •Malignancy as the indication for surgery
Arms & Interventions
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)
Intervention: Acetaminophen 500 mg Tab
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)
Intervention: OxyCODONE 5 mg Oral Tablet
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)
Intervention: Acetaminophen 500 mg Tab
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)
Intervention: Ibuprofen 600 mg
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)
Intervention: Ibuprofen 600 mg
Outcomes
Primary Outcomes
Pain score on post-operative day one
Time Frame: 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
Time Frame: 7 days
Numeric pain score on post-operative day seven: patient reported pain using the Likert pain scale from 0 to 10
Secondary Outcomes
- Mobility on postoperative day seven(7 days)
- Total opioid consumption on postoperative day one(1 day)
- Satisfaction of pain control on postoperative day one(1 day)
- Total opioid consumption on postoperative day seven(7 days)
- Opioid related side effects on postoperative day one(1 day)
- Satisfaction of pain control on postoperative day seven(7 days)
- Mobility on postoperative day one(1 day)
- Opioid related side effects on postoperative day seven(7 days)
- Unplanned calls/visits(7 days)