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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Self Reported Pain Score on Post Operative Day 1 (Numeric Pain Reporting Score: NRS) | Participants will be surveyed during the phone call survey to rate pain score on a scale from 0 (no pain), to 10 (severe pain) | 1 day post operative |
| Self Reported Pain Score on Post Operative Day 7 (Numeric Pain Reporting Score: NRS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ja Hyun Shin, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26517014 | Background | 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. | |
| 21669954 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). Acetaminophen: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) Ibuprofen 600 mg: 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed) Oxycodone: The number of tablets of oxycodone prescribed is the only difference between the two arms. |
| FG001 | 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). Acetaminophen: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) Ibuprofen 600 mg: 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed) Oxycodone: The number of tablets of oxycodone prescribed is the only difference between the two arms. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients were excluded who withdrew consent, failed the protocol (did not undergo the planned surgery).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). Acetaminophen: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) Ibuprofen 600 mg: 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed) Oxycodone: The number of tablets of oxycodone prescribed is the only difference between the two arms. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants answering Day 1 Survey | Posted | Median | Inter-Quartile Range | Oxycodone Tablets | 24 hours post-operative |
|
The follow up time included 6 weeks post operative
We used the same definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). Acetaminophen: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) Ibuprofen 600 mg: 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed) Oxycodone: The number of tablets of oxycodone prescribed is the only difference between the two arms. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kari Plewniak | Montefiore Medical Center | 718-920-5157 | kplewnia@montefiore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 19, 2018 | Sep 24, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D007052 | Ibuprofen |
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Patients are randomized to receive one of two prescription regimens.
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The treating provider and the patient know their prescription. The outcomes assessor will be blinded when administering the postoperative surveys.
|
| Ibuprofen 600 mg | Drug | 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed) |
|
|
| Oxycodone | Drug | The number of tablets of oxycodone prescribed is the only difference between the two arms. |
|
Participants will be surveyed during the phone call survey to rate pain score on a scale from 0 (no pain), to 10 (severe pain) |
| 7 days post operative |
| Additional Contacts With Provider | 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 | 1 week post operative |
| 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. |
| 29112660 | 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. |
| 28862884 | 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. |
| 21223499 | 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. |
| 27631771 | 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. |
| Protocol Violation |
|
| Did not complete Day 1 Survey |
|
| Did not complete Day 7 Survey |
|
| BG001 | 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). Acetaminophen: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) Ibuprofen 600 mg: 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed) Oxycodone: The number of tablets of oxycodone prescribed is the only difference between the two arms. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| OG001 | 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). Acetaminophen: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) Ibuprofen 600 mg: 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed) Oxycodone: The number of tablets of oxycodone prescribed is the only difference between the two arms. |
|
|
|
| Primary | 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. | Participants who answered survey on Day 7. Not all participants answered each question on follow up surveys. | Posted | Median | Inter-Quartile Range | Oxycodone Tablets | 7 days post-operative |
|
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|
|
| Secondary | Self Reported Pain Score on Post Operative Day 1 (Numeric Pain Reporting Score: NRS) | Participants will be surveyed during the phone call survey to rate pain score on a scale from 0 (no pain), to 10 (severe pain) | Participants completing Day 1 Survey | Posted | Median | Inter-Quartile Range | Score on Numeric Pain Scale | 1 day post operative |
|
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|
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| Secondary | Self Reported Pain Score on Post Operative Day 7 (Numeric Pain Reporting Score: NRS) | Participants will be surveyed during the phone call survey to rate pain score on a scale from 0 (no pain), to 10 (severe pain) | Participants completing Day 7 Survey | Posted | Median | Inter-Quartile Range | Score on Numeric Pain Scale | 7 days post operative |
|
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|
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| Secondary | Additional Contacts With Provider | 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 | Posted | Number | Unscheduled patient contacts | 1 week post operative |
|
|
|
|
| 0 |
| 57 |
| 0 |
| 57 |
| 0 |
| 57 |
| EG001 | 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). Acetaminophen: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) Ibuprofen 600 mg: 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed) Oxycodone: The number of tablets of oxycodone prescribed is the only difference between the two arms. | 0 | 57 | 0 | 57 | 0 | 57 |
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| Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |