Clinical trial NCT03588910: Ambulatory Gynecologic Surgery: Finding the Optimal Opioid Prescription
Official title: Ambulatory Gynecologic Surgery: Finding the Optimal Postoperative Opioid Prescription
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Surgery
Keywords: ambulatory
narcotics
opioids
postoperative
gynecology
laparoscopy
pain
surgery
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomized to receive one of two prescription regimens.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Oxycodone Tablets Used Day 1
timeFrame: 24 hours post-operative
measure: Number of Oxycodone Tablets Used as Reported by Participants 1 Week After Surgery
timeFrame: 7 days post-operative
Secondary outcomes:
measure: Self Reported Pain Score on Post Operative Day 1 (Numeric Pain Reporting Score: NRS)
timeFrame: 1 day post operative
measure: Self Reported Pain Score on Post Operative Day 7 (Numeric Pain Reporting Score: NRS)
timeFrame: 7 days post operative
measure: Additional Contacts With Provider
timeFrame: 1 week post operative
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Ja Hyun Shin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thomazeau J, Rouquette A, Martinez V, Rabuel C, Prince N, Laplanche JL, Nizard R, Bergmann JF, Perrot S, Lloret-Linares C. Acute pain Factors predictive of post-operative pain and opioid requirement in multimodal analgesia following knee replacement. Eur J Pain. 2016 May;20(5):822-32. doi: 10.1002/ejp.808. Epub 2015 Oct 30.
citation: De Oliveira GS Jr, Ahmad S, Fitzgerald PC, Marcus RJ, Altman CS, Panjwani AS, McCarthy RJ. Dose ranging study on the effect of preoperative dexamethasone on postoperative quality of recovery and opioid consumption after ambulatory gynaecological surgery. Br J Anaesth. 2011 Sep;107(3):362-71. doi: 10.1093/bja/aer156. Epub 2011 Jun 13.
citation: As-Sanie S, Till SR, Mowers EL, Lim CS, Skinner BD, Fritsch L, Tsodikov A, Dalton VK, Clauw DJ, Brummett CM. Opioid Prescribing Patterns, Patient Use, and Postoperative Pain After Hysterectomy for Benign Indications. Obstet Gynecol. 2017 Dec;130(6):1261-1268. doi: 10.1097/AOG.0000000000002344.
citation: Baruch AD, Morgan DM, Dalton VK, Swenson C. Opioid Prescribing Patterns by Obstetrics and Gynecology Residents in the United States. Subst Use Misuse. 2018 Jan 2;53(1):70-76. doi: 10.1080/10826084.2017.1323928. Epub 2017 Sep 1.
citation: Darnall B, Li H. Hysterectomy and predictors for opioid prescription in a chronic pain clinic sample. Pain Med. 2011 Feb;12(2):196-203. doi: 10.1111/j.1526-4637.2010.01038.x. Epub 2011 Jan 11.
citation: Hill MV, McMahon ML, Stucke RS, Barth RJ Jr. Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures. Ann Surg. 2017 Apr;265(4):709-714. doi: 10.1097/SLA.0000000000001993.