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WithdrawnNCT03792295Updated Aug 4, 2021

Multimodal Pain Therapy After Hernia Repair

A Phase 2 interventional study of acetominophen, ibuprofen, oxycodone and Oxycodone in Hernia, Abdominal and Pain, sponsored by Khashayar Vaziri. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-04.

Sponsored by Khashayar Vaziri · Phase 2, Interventional, and Treatment

Why this study was withdrawn
no enrollment, reallocation of resources
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

Investigating the effect of multimodal pain treatment after hernia repair

Read the detailed description

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.

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Conditions studied

  • Hernia, Abdominal
  • Pain
03

In context

Hernia, Abdominal

82 studies on the registry are indexed under Hernia, Abdominal; 19 are open to participants now.

Browse Hernia, Abdominal studies →

Lead sponsor

This is the only study on the registry with Khashayar Vaziri as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    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.

    Drug: acetominophen, ibuprofen, oxycodone

  • Active comparator
    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.

    Drug: Oxycodone

Interventions

  • Drugacetominophen, ibuprofen, oxycodone

    Drug pages: Acetaminophen · Ibuprofen · Oxycodone

    Multimodal pain treatment group

    Also known as: Tylenol, Advil, OxyContin

  • Classic opiod pain treatment group

    Also known as: OxyContin

06

What researchers measure

Primary outcomes

  1. Post operative pain scores at rest and during movement

    Patients will be called on post operative days 1-3 and asked to rate their pain while at rest and during movement using the following scales: On a scale of 1-10, with 1=no pain and 10= the worst pain, what has been your average pain level since surgery during REST? 1 2 3 4 5 6 7 8 9 10 On a scale of 1-10, with 1=no pain and 10= the worst pain, what has been your average pain level since surgery during MOVEMENT (such as walking across the room)? 1 2 3 4 5 6 7 8 9 10 Patients will also be asked the same two pain scales (pain at rest and during movement) at the first post-operative appointment, which will occur within 14 days of their surgery. The scores for pain at rest and during movement will not be summed or averaged together, so that the maximum score on each scale is 10 (worst pain), and the minimum score is 1 (no pain). Scores will not be summed across days. Lower scores are considered a better outcome, and higher scores are considered a worse outcome.

    Time frame: 1-14 days after surgery

Secondary outcomes

  1. Narcotic use

    Amount of oxycodone pills taken

    Time frame: 1-14 days after surgery

07

Study locations

1 site
  • George Washington University Hospital
    Washington, District of Columbia 20037, United States
08

References and documents

Publications

  • 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. PubMed 28033313 ↗
  • 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. Erratum In: JAMA Surg. 2019 Mar 1;154(3):272. doi: 10.1001/jamasurg.2018.5476. PubMed 28403427 ↗
  • 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. PubMed 25707723 ↗
  • 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. PubMed 28808868 ↗
  • 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. PubMed 27049780 ↗
  • 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. PubMed 25254998 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03792295
Lead sponsor
Khashayar Vaziri
Responsible party
Khashayar Vaziri (Associate Professor of Surgery, George Washington University) — Sponsor-investigator
First posted
Jan 3, 2019
Start date
Jul 1, 2021 (estimated)
Primary completion
Dec 1, 2021 (estimated)
Completion
Jul 1, 2022 (estimated)
Last update
Aug 4, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Acetaminophen · Ibuprofen · Oxycodone

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