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Multimodal Pain Therapy After Hernia Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03792295
Recruitment Status : Withdrawn (no enrollment, reallocation of resources)
First Posted : January 3, 2019
Last Update Posted : August 4, 2021
Information provided by (Responsible Party):
Khashayar Vaziri, George Washington University

Brief Summary:
Investigating the effect of multimodal pain treatment after hernia repair

Condition or disease Intervention/treatment Phase
Hernia, Abdominal Pain Drug: acetominophen, ibuprofen, oxycodone Drug: Oxycodone Phase 2

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Multimodal Pain Therapy After Hernia Repair
Estimated Study Start Date : July 1, 2021
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : July 1, 2022

Arm Intervention/treatment
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
Multimodal pain treatment group
Other Name: Tylenol, Advil, OxyContin

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
Classic opiod pain treatment group
Other Name: OxyContin

Primary Outcome Measures :
  1. Post operative pain scores at rest and during movement [ Time Frame: 1-14 days after surgery ]

    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.

Secondary Outcome Measures :
  1. Narcotic use [ Time Frame: 1-14 days after surgery ]
    Amount of oxycodone pills taken

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03792295

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United States, District of Columbia
George Washington University Hospital
Washington, District of Columbia, United States, 20037
Sponsors and Collaborators
Khashayar Vaziri

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Responsible Party: Khashayar Vaziri, Associate Professor of Surgery, George Washington University Identifier: NCT03792295    
Other Study ID Numbers: MultimodalHernia
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: August 4, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hernia, Abdominal
Internal Hernia
Pathological Conditions, Anatomical
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Central Nervous System Depressants