Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2021-07-01
2022-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Multimodal Therapy
Patients will receive scheduled ibuprofen 400mg po q 4 hours and acetominophen 1gram po q 8 hours during the post operative phase and oxycodone 5mg po q 4 to 6 hours as needed for pain control.
acetominophen, ibuprofen, oxycodone
Multimodal pain treatment group
Classic/standard opiod Therapy
Patients will receive oxycodone 5mg po q 4 to 6 hours as needed during their post operative phase for pain control.
Oxycodone
Classic opiod pain treatment group
Interventions
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acetominophen, ibuprofen, oxycodone
Multimodal pain treatment group
Oxycodone
Classic opiod pain treatment group
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* patients with a history of gastric ulcer or gastrointestinal bleeding
* patients with kidney disease
* patients with cardiovascular disease
* patients with a co-morbid condition that would prohibit them from taking narcotics
* patients with known or suspected narcotic abuse
* patients who do not wish to participate
18 Years
90 Years
ALL
Yes
Sponsors
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Khashayar Vaziri
OTHER
Responsible Party
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Khashayar Vaziri
Associate Professor of Surgery
Locations
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George Washington University Hospital
Washington D.C., District of Columbia, United States
Countries
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References
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Rudd RA, Seth P, David F, Scholl L. Increases in Drug and Opioid-Involved Overdose Deaths - United States, 2010-2015. MMWR Morb Mortal Wkly Rep. 2016 Dec 30;65(50-51):1445-1452. doi: 10.15585/mmwr.mm655051e1.
Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.
Manworren RC. Multimodal pain management and the future of a personalized medicine approach to pain. AORN J. 2015 Mar;101(3):308-14; quiz 315-8. doi: 10.1016/j.aorn.2014.12.009.
Warren JA, Stoddard C, Hunter AL, Horton AJ, Atwood C, Ewing JA, Pusker S, Cancellaro VA, Walker KB, Cobb WS, Carbonell AM, Morgan RR. Effect of Multimodal Analgesia on Opioid Use After Open Ventral Hernia Repair. J Gastrointest Surg. 2017 Oct;21(10):1692-1699. doi: 10.1007/s11605-017-3529-4. Epub 2017 Aug 14.
Majumder A, Fayezizadeh M, Neupane R, Elliott HL, Novitsky YW. Benefits of Multimodal Enhanced Recovery Pathway in Patients Undergoing Open Ventral Hernia Repair. J Am Coll Surg. 2016 Jun;222(6):1106-15. doi: 10.1016/j.jamcollsurg.2016.02.015. Epub 2016 Mar 3.
Fayezizadeh M, Petro CC, Rosen MJ, Novitsky YW. Enhanced recovery after surgery pathway for abdominal wall reconstruction: pilot study and preliminary outcomes. Plast Reconstr Surg. 2014 Oct;134(4 Suppl 2):151S-159S. doi: 10.1097/PRS.0000000000000674.
Other Identifiers
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MultimodalHernia
Identifier Type: -
Identifier Source: org_study_id
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