Hernia, AbdominalPhase 2NCT03792295
Multimodal Pain Therapy After Hernia Repair
A Phase 2 study testing acetominophen, ibuprofen, oxycodone and Oxycodone in people with Hernia, Abdominal and Pain, run by Khashayar Vaziri at 1 site in United States.
Trial summary
Investigating the effect of multimodal pain treatment after hernia repair Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hernia, Abdominal, Pain
- What is being tested?
- acetominophen, ibuprofen, oxycodone and Oxycodone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 1 Jul 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
George Washington University Hospital
Washington D.C., District of Columbia, 20037
About this study
Official title: The Effect of Multimodal Pain Therapy After Hernia Repair
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.
- Conditions
- Hernia, Abdominal, Pain
- Being tested
- acetominophen, ibuprofen, oxycodone, Oxycodone
- Medical subject headings
- Hernia, Abdominal, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetominophen, ibuprofen, oxycodoneDrug
Also called Tylenol, Advil, OxyContin
Multimodal pain treatment group
OxycodoneDrug
Also called OxyContin
Classic opiod pain treatment group
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-14 days after surgery
Secondary outcomes (1)
Narcotic use
Amount of oxycodone pills taken
Measured: 1-14 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start1 Jul 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Jul 2022 (estimated)
Why it stopped: no enrollment, reallocation of resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hernia, AbdominalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khashayar Vaziri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Khashayar Vaziri, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792295
- Sponsor's protocol ID
- MultimodalHernia
- Status last verified
- Jul 2021
- First submitted
- 27 Dec 2018
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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 28033313Brummett 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.
PubMed 28403427Manworren 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 25707723Warren 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 28808868Majumder 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 27049780Fayezizadeh 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Multimodal Pain Therapy After Hernia Repair
- ClinicalTrials.gov ID
- NCT03792295
- Acronym / sponsor ID
- MultimodalHernia
- Conditions
- Hernia, Abdominal, Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no enrollment, reallocation of resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Khashayar VaziriUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 3 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal Therapy | Experimental | Drug: acetominophen, ibuprofen, oxycodonePatients 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. |
| Classic/standard opiod Therapy | Active comparator | Drug: OxycodonePatients will receive oxycodone 5mg po q 4 to 6 hours as needed during their post operative phase for pain control. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acetominophen, ibuprofen, oxycodoneAlso: Tylenol, Advil, OxyContinMultimodal pain treatment group | Drug | Multimodal Therapy |
| OxycodoneAlso: OxyContinClassic opiod pain treatment group | Drug | Classic/standard opiod Therapy |
Primary outcome
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.
1 secondary outcome
Narcotic use
Time frame: 1-14 days after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Background: PubMed 28033313Rudd 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.
- Background: PubMed 28403427Brummett 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.
- Background: PubMed 25707723Manworren 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.
- Background: PubMed 28808868Warren 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.
- Background: PubMed 27049780Majumder 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.
- Background: PubMed 25254998Fayezizadeh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing acetominophen, ibuprofen, oxycodone and Oxycodone in people with Hernia, Abdominal and Pain, run by Khashayar Vaziri at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative pain scores at rest and during movement (time frame: 1-14 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03792295, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.