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Ambulatory Gynecologic Surgery: Finding the Optimal Opioid Prescription

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ClinicalTrials.gov Identifier: NCT03588910
Recruitment Status : Recruiting
First Posted : July 17, 2018
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Ja hyun Shin, 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.

Condition or disease Intervention/treatment Phase
Surgery Drug: Acetaminophen Drug: Ibuprofen 600 mg Drug: Oxycodone Phase 2

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 Oxcodone 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients are randomized to receive one of two prescription regimens.
Masking: Single (Outcomes Assessor)
Masking Description: The treating provider and the patient know their prescription. The outcomes assessor will be blinded when administering the postoperative surveys.
Primary Purpose: Treatment
Official Title: Ambulatory Gynecologic Surgery: Finding the Optimal Postoperative Opioid Prescription
Actual Study Start Date : August 8, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : October 1, 2019


Arm Intervention/treatment
Active Comparator: 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).
Drug: Acetaminophen
50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)
Other Name: Tylenol

Drug: Ibuprofen 600 mg
25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)
Other Name: Motrin

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

Experimental: 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).
Drug: Acetaminophen
50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)
Other Name: Tylenol

Drug: Ibuprofen 600 mg
25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)
Other Name: Motrin

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




Primary Outcome Measures :
  1. Number of oxycodone tablets used as reported by participants 1 day after surgery [ Time Frame: 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.

  2. Number of oxycodone tablets used as reported by participants 1 week after surgery [ Time Frame: 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 :
  1. Self reported pain score on post operative day 1 [ Time Frame: 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)

  2. Self reported pain score on post operative day 7 [ Time Frame: 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)

  3. Additional contacts with provider [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03588910


Contacts
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Contact: Kari M Plewniak, MD BS 716-909-6976 kmplewniak@gmail.com
Contact: Ja Hyun Shin, MD (718) 920-7294 jashin@montefiore.org

Locations
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United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Ja Hyun Shin, MD    718-920-7294      
Contact: Giselle Tatis    718-920-8382      
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Ja Hyun Shin, MD Montefiore Medical Center

Additional Information:
Publications:

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Responsible Party: Ja hyun Shin, Director, Pelvic Pain clinic. Associate Fellowship Director. Assistant professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03588910     History of Changes
Other Study ID Numbers: 2018-8755
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ja hyun Shin, Montefiore Medical Center:
ambulatory
narcotics
opioids
postoperative
gynecology
laparoscopy
pain
surgery

Additional relevant MeSH terms:
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Analgesics, Opioid
Oxycodone
Acetaminophen
Ibuprofen
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action