Ambulatory Gynecologic Surgery: Finding the Optimal Opioid Prescription

July 21, 2021 updated by: Kari Plewniak, Montefiore Medical Center

Ambulatory Gynecologic Surgery: Finding the Optimal Postoperative Opioid Prescription

Currently there is a nationwide epidemic in opioid abuse and overdose deaths. While the opioid epidemic is multi-factorial one major source of excess opioids may be over-prescribing in the post-operative period. There is wide variation in the prescribing practices for post-operative pain control and there is no standard of care for pain control after minor laparoscopic surgery in general or after gynecologic laparoscopy. There is also evidence to show that on average half of the opioids prescribed are unused by the patient. The aim of the study is to evaluate two opioid prescription regimens.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This will be a randomized controlled study enrolling participants scheduled for outpatient minor laparoscopic gynecologic surgery. This is a two arm study consisting of 60 subjects in each arm. The participants will be randomized at the time of enrollment. We will use computer generated blocks of four participants. Both arms of participants will receive the same non-narcotic pain medication prescriptions which will include fifty tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and twenty-five tablets ibuprofen 600mg (1 tablet every 6 hours as needed). The arms will only differ in the number of tablets of oxycodone prescribed. In one arm (experimental) subjects will receive five tablets of oxycodone 5mg (1 tablet every 6 hours as needed) and the other arm (comparator) ten tablets of oxycodone 5mg (1 tablet every 6 hours as needed). Both prescription regimens are within the range of normal clinical practice for post-operative pain control.

The participants will receive a telephone call by administrative staff, who is not directly involved in the participants care or data collection for the study subjects, on postoperative day 1 and 7. The participants will all be scheduled for a 2- week post-operative follow up with the surgeon in the office. The primary outcome to be assessed will be number of opioids used by the participants at 24 hours and 7 days post-operative. The primary hypothesis is that participants prescribed only 5 tabs of oxycodone will not require more medication. The secondary hypothesis is that the pain scores between the two groups will not be different. The other variables being studied include the following: having had a post-operative bowel movement, presence of nausea, number of ibuprofen, acetaminophen tablets remaining, calls to the office prior to the follow up visit for pain issues, and urgent or emergency department visits for pain issues. These assessments will be asked during the brief telephone calls and also at the postoperative visit.

All participants will be given the clinic phone number and advised to call with any questions or clinical concerns. The participants will be advised if possible to return to a Montefiore Emergency Department or gynecologic provider in case of an urgent issue prior to the 2 week postoperative visit, as opposed to an outside facility.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Must be over 18 years of age
  • Scheduled for outpatient gynecologic laparoscopy

Exclusion Criteria:

  • Significant renal or liver disease is present that would alter prescribing patterns
  • Chronic opioid use or abuse
  • Allergy to acetaminophen, ibuprofen, other nsaids or narcotic medications
  • Conversion of surgery to exploratory laparotomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Number of oxycodone tablets typically prescribed
Participants will receive a prescription for 10 tablets of 5 mg oxycodone (1 tablet every 6 hours as needed) as well as 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed).
Drug: Acetaminophen
50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)
Other Names:
  • Tylenol
Drug: Ibuprofen 600 mg
25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)
Other Names:
  • Motrin
Drug: Oxycodone
The number of tablets of oxycodone prescribed is the only difference between the two arms.
Experimental: Half the number of oxycodone tablets typically prescribed
Participants will receive 5 tablets of 5mg oxycodone as well as 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed).
Drug: Acetaminophen
50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)
Other Names:
  • Tylenol
Drug: Ibuprofen 600 mg
25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)
Other Names:
  • Motrin
Drug: Oxycodone
The number of tablets of oxycodone prescribed is the only difference between the two arms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Oxycodone Tablets Used Day 1
Time Frame: 24 hours post-operative
During the survey phone call on day 1, participants will be asked to report the total number of oxycodone tablets use since the surgery.
24 hours post-operative
Number of Oxycodone Tablets Used as Reported by Participants 1 Week After Surgery
Time Frame: 7 days post-operative
During the survey phone call on day 7, participants will be asked to report the total number of oxycodone tablets used since the surgery.
7 days post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self Reported Pain Score on Post Operative Day 1 (Numeric Pain Reporting Score: NRS)
Time Frame: 1 day post operative
Participants will be surveyed during the phone call survey to rate pain score on a scale from 0 (no pain), to 10 (severe pain)
1 day post operative
Self Reported Pain Score on Post Operative Day 7 (Numeric Pain Reporting Score: NRS)
Time Frame: 7 days post operative
Participants will be surveyed during the phone call survey to rate pain score on a scale from 0 (no pain), to 10 (severe pain)
7 days post operative
Additional Contacts With Provider
Time Frame: 1 week post operative
By chart review, unscheduled interactions with the healthcare system related to pain will be counted.These will include phone calls related to pain, unscheduled visits to the office or emergency department
1 week post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Ja Hyun Shin, MD, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2018

Primary Completion (Actual)

July 4, 2019

Study Completion (Actual)

August 4, 2019

Study Registration Dates

First Submitted

February 16, 2018

First Submitted That Met QC Criteria

July 15, 2018

First Posted (Actual)

July 17, 2018

Study Record Updates

Last Update Posted (Actual)

August 13, 2021

Last Update Submitted That Met QC Criteria

July 21, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-8755

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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