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Multimodal Pain Therapy After Hernia Repair

K

Khashayar Vaziri

Status and phase

Withdrawn
Phase 2

Conditions

Hernia, Abdominal
Pain

Treatments

Drug: acetominophen, ibuprofen, oxycodone
Drug: Oxycodone

Study type

Interventional

Funder types

Other

Identifiers

NCT03792295
MultimodalHernia

Details and patient eligibility

About

Investigating the effect of multimodal pain treatment after hernia repair

Full 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.

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Multimodal Therapy
Experimental group
Description:
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.
Treatment:
Drug: acetominophen, ibuprofen, oxycodone
Classic/standard opiod Therapy
Active Comparator group
Description:
Patients will receive oxycodone 5mg po q 4 to 6 hours as needed during their post operative phase for pain control.
Treatment:
Drug: Oxycodone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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