Reduced Opioid Prescription After Laparoscopic Hysterectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-12

Study Completion Date

2026-12-31

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.

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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.

Conditions

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Pain, Postoperative Opioid Misuse Opioid Use Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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)

Group Type OTHER

OxyCODONE 5 mg Oral Tablet

Intervention Type DRUG

No opioid prescription after laparoscopic hysterectomy

Acetaminophen 500 mg Tab

Intervention Type DRUG

Standard prescription

Ibuprofen 600 mg

Intervention Type DRUG

Standard prescription

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)

Group Type ACTIVE_COMPARATOR

Acetaminophen 500 mg Tab

Intervention Type DRUG

Standard prescription

Ibuprofen 600 mg

Intervention Type DRUG

Standard prescription

Interventions

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OxyCODONE 5 mg Oral Tablet

No opioid prescription after laparoscopic hysterectomy

Intervention Type DRUG

Acetaminophen 500 mg Tab

Standard prescription

Intervention Type DRUG

Ibuprofen 600 mg

Standard prescription

Intervention Type DRUG

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
* Malignancy as the indication for surgery

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes