Multimodal Pain Therapy After Hernia Repair

Phase 2

Withdrawn

• Conditions: Hernia, Abdominal; Pain
• Interventions: Drug: Oxycodone; Drug: acetominophen, ibuprofen, oxycodone

• Registration Number: NCT03792295
• Lead Sponsor: Khashayar Vaziri

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.

Study Timeline

• Study First Submitted: 2018-12-27
• Study First Submitted QC: 2018-12-31
• Study First Posted: 2019-01-03
• Status Verified: 2021-07
• Study Start: 2021-07-01
• Last Update Submitted: 2021-07-28
• Last Update Posted: 2021-08-04
• Primary Completion: 2021-12-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Classic/standard opiod Therapy	Oxycodone	Patients will receive oxycodone 5mg po q 4 to 6 hours as needed during their post operative phase for pain control.
Multimodal Therapy	acetominophen, ibuprofen, oxycodone	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Narcotic use	1-14 days after surgery	Amount of oxycodone pills taken

Trial Locations

Locations (1)

George Washington University Hospital; 🇺🇸 Washington, District of Columbia, United States