Multimodal Pain Therapy After Hernia Repair

NCT ID: NCT03792295

Last Updated: 2021-08-04

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-07-01

Brief Summary

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Investigating the effect of multimodal pain treatment after hernia repair

Detailed Description

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This is a randomized, non-blinded study comparing the effects of multimodal pain management (ibuprofen, tylenol, and narcotics/oxycodone as needed) for relief of post-operative pain in patients who undergo hernia repair. Patients who present for elective hernia surgery will be randomized in a 1:1 fashion by pre-operative pain score into a multimodal pain treatment group or conventional opiod treatment group for post-operative pain management. They will be followed up after their surgery to evaluate their pain scores and narcotic use.

Conditions

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Hernia, Abdominal Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

acetominophen, ibuprofen, oxycodone

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Oxycodone

Intervention Type DRUG

Classic opiod pain treatment group

Interventions

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acetominophen, ibuprofen, oxycodone

Multimodal pain treatment group

Intervention Type DRUG

Oxycodone

Classic opiod pain treatment group

Intervention Type DRUG

Other Intervention Names

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Tylenol, Advil, OxyContin OxyContin

Eligibility Criteria

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Inclusion Criteria

* Healthy adult patients \>18 years of age to 90 years of age who are eligible for a hernia repair (ventral or inguinal) by a surgeon in the Medical Faculty Associates Department of General Surgery at the George Washington University Hospital.

Exclusion Criteria

* Patients with allergies to sulfa or any of the medications being evaluated in this study (ibuprofen, tylenol, oxycodone)
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Khashayar Vaziri

OTHER

Sponsor Role lead

Responsible Party

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Khashayar Vaziri

Associate Professor of Surgery

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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George Washington University Hospital

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 28033313 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28403427 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25707723 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28808868 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27049780 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25254998 (View on PubMed)

Other Identifiers

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MultimodalHernia

Identifier Type: -

Identifier Source: org_study_id

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