Multimodal Pain Therapy After Hernia Repair

NCT03792295 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: MultimodalHernia
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Investigating the effect of multimodal pain treatment after hernia repair

Conditions

Hernia, Abdominal; Pain

Outcome Measures

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.

  1-14 days after surgery

Secondary Outcomes (1)

• Narcotic use

  1-14 days after surgery

Study Arms (2)

Multimodal Therapy

EXPERIMENTAL

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

Classic/standard opiod Therapy

ACTIVE COMPARATOR

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

Drug: Oxycodone

Interventions

acetominophen, ibuprofen, oxycodone DRUG

Multimodal pain treatment group

Also known as: Tylenol, Advil, OxyContin

Multimodal Therapy

Oxycodone DRUG

Classic opiod pain treatment group

Also known as: OxyContin

Classic/standard opiod Therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Khashayar Vaziri: lead

Study Sites (1)

George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

Location

Related Publications (6)

• 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.

  PMID: 28033313 BACKGROUND

• 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.

  PMID: 28403427 BACKGROUND

• 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.

  PMID: 25707723 BACKGROUND

• 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.

  PMID: 28808868 BACKGROUND

• 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.

  PMID: 27049780 BACKGROUND

• 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.

  PMID: 25254998 BACKGROUND

MeSH Terms

Conditions

Hernia, Abdominal; Pain

Interventions

Acetaminophen; Ibuprofen; Oxycodone

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: January 3, 2019
• Study Start: July 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: July 1, 2022
• Last Updated: August 4, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)