Multimodal Pain Therapy After Hernia Repair

Sponsor

Khashayar Vaziri (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03792295

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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

Anticipated Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

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 Names: 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 Names: OxyContin

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 Names:

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 Names:

OxyContin

Outcome Measures

Primary Outcome Measures

Post operative pain scores at rest and during movement [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

Narcotic use [1-14 days after surgery]
Amount of oxycodone pills taken

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

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