Ambulatory Gynecologic Surgery: Finding the Optimal Opioid Prescription

Study Overview
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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.

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.

Official Title
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Ambulatory Gynecologic Surgery: Finding the Optimal Postoperative Opioid Prescription

Conditions
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Surgery

Intervention / Treatment
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* Drug: Acetaminophen
* Drug: Ibuprofen 600 mg
* Drug: Oxycodone


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients are randomized to receive one of two prescription regimens.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Number of oxycodone tablets typically prescribed<br>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<br>* 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)<br>* Other names: Tylenol;Drug: Ibuprofen 600 mg<br>* 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)<br>* Other names: Motrin;Drug: Oxycodone<br>* The number of tablets of oxycodone prescribed is the only difference between the two arms.<br>|
| Experimental: Half the number of oxycodone tablets typically prescribed<br>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<br>* 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)<br>* Other names: Tylenol;Drug: Ibuprofen 600 mg<br>* 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)<br>* Other names: Motrin;Drug: Oxycodone<br>* The number of tablets of oxycodone prescribed is the only difference between the two arms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Oxycodone Tablets Used Day 1 | 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 | 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) | 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) | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ambulatory, narcotics, opioids, postoperative, gynecology, laparoscopy, pain, surgery