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Completed

NCT Number: NCT03588910

Ambulatory Gynecologic Surgery: Finding the Optimal Opioid Prescription

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetaminophen

Drug

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

Other names: Tylenol

Ibuprofen 600 mg

Drug

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

Other names: Motrin

Oxycodone

Drug

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

Primary outcomes

  1. Number of Oxycodone Tablets Used Day 1

    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 outcomes

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

    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 (Numeric Pain Reporting Score: NRS)

    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

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

Ambulatory Gynecologic Surgery: Finding the Optimal Postoperative Opioid Prescription

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 17, 2018
Registry last updated
Aug 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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