Reduced Opioid Prescription After Laparoscopic Hysterectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Postoperative, Opioid Misuse, Opioid Use, Pain

Intervention / Treatment
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* Drug: OxyCODONE 5 mg Oral Tablet
* Drug: Acetaminophen 500Mg Tab
* Drug: Ibuprofen 600 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Post-operative opioid prescription<br>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<br>* No opioid prescription after laparoscopic hysterectomy<br>Drug: Acetaminophen 500Mg Tab<br>* Standard prescription<br>Drug: Ibuprofen 600 mg<br>* Standard prescription<br>|
| Active Comparator: No Opioid prescription<br>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<br>* Standard prescription<br>Drug: Ibuprofen 600 mg<br>* Standard prescription<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

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