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Active, Not Recruiting

NCT Number: NCT05548582

Reduced Opioid Prescription After Laparoscopic Hysterectomy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pain, Postoperative Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Neurologic Manifestations Opioid Misuse Opioid Use Opioid-Related Disorders Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OxyCODONE 5 Mg Oral Tablet

Drug

No opioid prescription after laparoscopic hysterectomy

Acetaminophen 500 mg Tab

Drug

Standard prescription

Ibuprofen 600 mg

Drug

Standard prescription

Primary outcomes

  1. 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

  2. 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

  1. Satisfaction of pain control on postoperative day one

    Time frame: 1 day

    Overall satisfaction of pain control on postoperative day one (binary question - Yes/No)

  2. Satisfaction of pain control on postoperative day seven

    Time frame: 7 days

    Overall satisfaction of pain control on postoperative day seven (binary question - Yes/No)

  3. Mobility on postoperative day one

    Time frame: 1 day

    Satisfaction with mobility on postoperative day one (binary question - Yes/No)

  4. Mobility on postoperative day seven

    Time frame: 7 days

    Satisfaction with mobility on postoperative day seven (binary question - Yes/No)

  5. Total opioid consumption on postoperative day one

    Time frame: 1 day

    Total narcotic consumption by postoperative day one (in morphine milligram equivalent)

  6. Total opioid consumption on postoperative day seven

    Time frame: 7 days

    Total narcotic consumption by postoperative day seven (in morphine milligram equivalent)

  7. Opioid related side effects on postoperative day one

    Time frame: 1 day

    Presence of opioid related side effects such as nausea, vomiting, constipation, dizziness, abdominal distention, and itchiness on postoperative day one (binary question - Yes/No)

  8. Opioid related side effects on postoperative day seven

    Time frame: 7 days

    Presence of opioid related side effects such as nausea, vomiting, constipation, dizziness, abdominal distention, and itchiness on postoperative day seven (binary question - Yes/No)

  9. Unplanned calls/visits

    Time frame: 7 days

    Unplanned visits to the emergency room or clinic and unexpected patient initiated phone call related to pain control postoperatively (binary question - Yes/No)

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 21, 2022
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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