The Effect of Multimodal Pain Therapy After Hernia Repair
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- Post operative pain scores at rest and during movement
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
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.
Intervention: acetominophen, ibuprofen, oxycodone (Drug)
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.
Intervention: Oxycodone (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Narcotic use(1-14 days after surgery)
Investigators
Khashayar Vaziri
Associate Professor of Surgery
George Washington University