Ambulatory Gynecologic Surgery: Finding the Optimal Opioid Prescription

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-08

Study Completion Date

2019-08-04

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients are randomized to receive one of two prescription regimens.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The treating provider and the patient know their prescription. The outcomes assessor will be blinded when administering the postoperative surveys.

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)

Ibuprofen 600 mg

Intervention Type DRUG

25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)

Oxycodone

Intervention Type DRUG

The number of tablets of oxycodone prescribed is the only difference between the two arms.

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).

Group Type EXPERIMENTAL

Acetaminophen

Intervention Type DRUG

50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)

Ibuprofen 600 mg

Intervention Type DRUG

25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)

Oxycodone

Intervention Type DRUG

The number of tablets of oxycodone prescribed is the only difference between the two arms.

Interventions

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Acetaminophen

50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)

Intervention Type DRUG

Ibuprofen 600 mg

25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)

Intervention Type DRUG

Oxycodone

The number of tablets of oxycodone prescribed is the only difference between the two arms.

Intervention Type DRUG

Other Intervention Names

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Tylenol Motrin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes