Reduced Opioid Prescription After Laparoscopic Hysterectomy

Johns Hopkins University

Status: Active, not recruiting

Conditions: Pain, Postoperative; Opioid Use; Pain; Opioid Misuse

Treatments: Drug: OxyCODONE 5 mg Oral Tablet; Drug: Acetaminophen 500 mg Tab; Drug: Ibuprofen 600 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05548582

IRB00345074

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Post-operative opioid prescription

Other group

Description:

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)

Treatment:

Drug: Ibuprofen 600 mg

Drug: Acetaminophen 500 mg Tab

Drug: OxyCODONE 5 mg Oral Tablet

No Opioid prescription

Active Comparator group

Description:

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)

Treatment:

Drug: Ibuprofen 600 mg

Drug: Acetaminophen 500 mg Tab