Ambulatory Gynecologic Surgery: Finding the Optimal Opioid Prescription

NCT03588910 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 2018-8755
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Keywords

ambulatory; narcotics; opioids; postoperative; gynecology; laparoscopy; pain; surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Self Reported Pain Score on Post Operative Day 1 (Numeric Pain Reporting Score: NRS)

  1 day post operative

• Self Reported Pain Score on Post Operative Day 7 (Numeric Pain Reporting Score: NRS)

  7 days post operative

• Additional Contacts With Provider

  1 week post operative

Study Arms (2)

Number of oxycodone tablets typically prescribed

ACTIVE COMPARATOR

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; Drug: Ibuprofen 600 mg; Drug: Oxycodone

Half the number of oxycodone tablets typically prescribed

EXPERIMENTAL

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; Drug: Ibuprofen 600 mg; Drug: Oxycodone

Interventions

Acetaminophen DRUG

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

Also known as: Tylenol

Half the number of oxycodone tablets typically prescribed; Number of oxycodone tablets typically prescribed

Ibuprofen 600 mg DRUG

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

Also known as: Motrin

Half the number of oxycodone tablets typically prescribed; Number of oxycodone tablets typically prescribed

Oxycodone DRUG

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

Half the number of oxycodone tablets typically prescribed; Number of oxycodone tablets typically prescribed

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (6)

• 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.

  PMID: 26517014 BACKGROUND

• 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.

  PMID: 21669954 BACKGROUND

• 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.

  PMID: 29112660 BACKGROUND

• 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.

  PMID: 28862884 BACKGROUND

• 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.

  PMID: 21223499 BACKGROUND

• 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.

  PMID: 27631771 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Acetaminophen; Ibuprofen; Oxycodone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Kari Plewniak
• Organization: Montefiore Medical Center

kplewnia@montefiore.org

718-920-5157

Study Officials

• Ja Hyun Shin, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The treating provider and the patient know their prescription. The outcomes assessor will be blinded when administering the postoperative surveys.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pelvic Pain clinic. Associate Fellowship Director. Assistant professor

Model Details: Patients are randomized to receive one of two prescription regimens.

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: July 17, 2018
• Study Start: August 8, 2018
• Primary Completion: July 4, 2019
• Study Completion: August 4, 2019
• Last Updated: August 13, 2021
• Results First Posted: August 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)