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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

Tracking Information
First Submitted Date  ICMJE February 16, 2018
First Posted Date  ICMJE July 17, 2018
Last Update Posted Date February 20, 2019
Actual Study Start Date  ICMJE August 8, 2018
Estimated Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03588910 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2018)
  • 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)
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ambulatory Gynecologic Surgery: Finding the Optimal Opioid Prescription
Official Title  ICMJE Ambulatory Gynecologic Surgery: Finding the Optimal Postoperative Opioid Prescription
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Surgery
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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).
    Interventions:
    • Drug: Acetaminophen
    • Drug: Ibuprofen 600 mg
    • Drug: Oxycodone
  • 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).
    Interventions:
    • Drug: Acetaminophen
    • Drug: Ibuprofen 600 mg
    • Drug: Oxycodone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 15, 2018)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2019
Estimated Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Kari M Plewniak, MD BS 716-909-6976 kmplewniak@gmail.com
Contact: Ja Hyun Shin, MD (718) 920-7294 jashin@montefiore.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03588910
Other Study ID Numbers  ICMJE 2018-8755
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ja hyun Shin, Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ja Hyun Shin, MD Montefiore Medical Center
PRS Account Montefiore Medical Center
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP