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Multimodal Pain Therapy After Hernia Repair

Primary Purpose

Hernia, Abdominal, Pain

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
acetominophen, ibuprofen, oxycodone
Oxycodone
Sponsored by
Khashayar Vaziri
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Abdominal

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • George Washington University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multimodal Therapy

Classic/standard opiod Therapy

Arm 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.

Patients will receive oxycodone 5mg po q 4 to 6 hours as needed during their post operative phase for pain control.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Narcotic use
Amount of oxycodone pills taken

Full Information

First Posted
December 27, 2018
Last Updated
July 28, 2021
Sponsor
Khashayar Vaziri
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1. Study Identification

Unique Protocol Identification Number
NCT03792295
Brief Title
Multimodal Pain Therapy After Hernia Repair
Official Title
The Effect of Multimodal Pain Therapy After Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Withdrawn
Why Stopped
no enrollment, reallocation of resources
Study Start Date
July 1, 2021 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Khashayar Vaziri

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Abdominal, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multimodal Therapy
Arm Type
Experimental
Arm 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.
Arm Title
Classic/standard opiod Therapy
Arm Type
Active Comparator
Arm Description
Patients will receive oxycodone 5mg po q 4 to 6 hours as needed during their post operative phase for pain control.
Intervention Type
Drug
Intervention Name(s)
acetominophen, ibuprofen, oxycodone
Other Intervention Name(s)
Tylenol, Advil, OxyContin
Intervention Description
Multimodal pain treatment group
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Other Intervention Name(s)
OxyContin
Intervention Description
Classic opiod pain treatment group
Primary Outcome Measure Information:
Title
Post operative pain scores at rest and during movement
Description
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 Outcome Measure Information:
Title
Narcotic use
Description
Amount of oxycodone pills taken
Time Frame
1-14 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
George Washington University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28033313
Citation
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.
Results Reference
background
PubMed Identifier
28403427
Citation
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.
Results Reference
background
PubMed Identifier
25707723
Citation
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.
Results Reference
background
PubMed Identifier
28808868
Citation
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.
Results Reference
background
PubMed Identifier
27049780
Citation
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.
Results Reference
background
PubMed Identifier
25254998
Citation
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.
Results Reference
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Multimodal Pain Therapy After Hernia Repair

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