Ambulatory Gynecologic Surgery: Finding the Optimal Opioid Prescription

Phase 2

Completed

Conditions: Surgery

Interventions: Drug: Acetaminophen
Drug: Ibuprofen 600 mg
Drug: Oxycodone

Registration Number: NCT03588910

Lead Sponsor: Montefiore Medical Center

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 120

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Number of oxycodone tablets typically prescribed	Ibuprofen 600 mg	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).
Half the number of oxycodone tablets typically prescribed	Ibuprofen 600 mg	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).
Number of oxycodone tablets typically prescribed	Acetaminophen	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).
Number of oxycodone tablets typically prescribed	Oxycodone	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).
Half the number of oxycodone tablets typically prescribed	Acetaminophen	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).
Half the number of oxycodone tablets typically prescribed	Oxycodone	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).

Primary Outcome Measures

Name	Time	Method
Number of Oxycodone Tablets Used Day 1	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.
Number of Oxycodone Tablets Used as Reported by Participants 1 Week After Surgery	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.

Secondary Outcome Measures

Name	Time	Method
Self Reported Pain Score on Post Operative Day 1 (Numeric Pain Reporting Score: NRS)	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)
Additional Contacts With Provider	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
Self Reported Pain Score on Post Operative Day 7 (Numeric Pain Reporting Score: NRS)	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)