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Multimodal Pain Therapy After Hernia Repair

The Effect of Multimodal Pain Therapy After Hernia Repair

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03792295
Enrollment
0
Registered
2019-01-03
Start date
2021-07-01
Completion date
2022-07-01
Last updated
2021-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hernia, Abdominal, Pain

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.

Interventions

DRUGacetominophen, ibuprofen, oxycodone

Multimodal pain treatment group

DRUGOxycodone

Classic opiod pain treatment group

Sponsors

Khashayar Vaziri
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Post operative pain scores at rest and during movement1-14 days after surgeryPatients 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

MeasureTime frameDescription
Narcotic use1-14 days after surgeryAmount of oxycodone pills taken

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026