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Given the nationwide epidemic of opioid use and abuse (in part due to over prescription), this study aims at addressing the need for opioid prescription after laparoscopic hysterectomy.
Currently, there is a nationwide epidemic of opioid abuse and overdose deaths. One source of excess opioids is overprescribing in the postoperative period. Given the increasing opioid abuse and over-prescription post-operatively, an effort must be made to determine whether non-opioid multimodal medications are adequate in treating postoperative pain after laparoscopic hysterectomy and would not increase the need for additional prescriptions or unscheduled patient contacts. This study aims to find the optimal prescriptions for pain after laparoscopic hysterectomy in an attempt to eliminate opioid use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-operative opioid prescription | Other | Ibuprofen 600mg every 6 hours x 48 hours then as needed (total 30 tablets). If allergy or contraindication to ibuprofen, then will receive Meloxicam 15mg daily x 48 hours then as needed Acetaminophen 500mg every 6 hours x 48 hours then as needed (total 30 tablets) Oxycodone 5mg every 4 hours as needed (total 12 tablets) |
|
| No Opioid prescription | Active Comparator | Ibuprofen 600mg every 6 hours x 48 hours then as needed (total 30 tablets). If allergy or contraindication to ibuprofen, will receive Meloxicam 15mg daily x 48 hours then as needed Acetaminophen 500mg every 6 hours x 48 hours then as needed (total 30 tablets) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OxyCODONE 5 mg Oral Tablet | Drug | No opioid prescription after laparoscopic hysterectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain score on post-operative day one | Numeric pain score on post-operative day one: patient reported pain using the Likert pain scale from 0 to 10 | 1 day |
| Pain score on post-operative day seven | Numeric pain score on post-operative day seven: patient reported pain using the Likert pain scale from 0 to 10 | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction of pain control on postoperative day one | Overall satisfaction of pain control on postoperative day one (binary question - Yes/No) | 1 day |
| Satisfaction of pain control on postoperative day seven |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mostafa Borahay | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D009293 | Opioid-Related Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| D013607 | Tablets |
| D000082 | Acetaminophen |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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| Acetaminophen 500 mg Tab | Drug | Standard prescription |
|
| Ibuprofen 600 mg | Drug | Standard prescription |
|
Overall satisfaction of pain control on postoperative day seven (binary question - Yes/No)
| 7 days |
| Mobility on postoperative day one | Satisfaction with mobility on postoperative day one (binary question - Yes/No) | 1 day |
| Mobility on postoperative day seven | Satisfaction with mobility on postoperative day seven (binary question - Yes/No) | 7 days |
| Total opioid consumption on postoperative day one | Total narcotic consumption by postoperative day one (in morphine milligram equivalent) | 1 day |
| Total opioid consumption on postoperative day seven | Total narcotic consumption by postoperative day seven (in morphine milligram equivalent) | 7 days |
| Opioid related side effects on postoperative day one | Presence of opioid related side effects such as nausea, vomiting, constipation, dizziness, abdominal distention, and itchiness on postoperative day one (binary question - Yes/No) | 1 day |
| Opioid related side effects on postoperative day seven | Presence of opioid related side effects such as nausea, vomiting, constipation, dizziness, abdominal distention, and itchiness on postoperative day seven (binary question - Yes/No) | 7 days |
| Unplanned calls/visits | Unplanned visits to the emergency room or clinic and unexpected patient initiated phone call related to pain control postoperatively (binary question - Yes/No) | 7 days |
| D012816 | Signs and Symptoms |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| 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 |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |