Hydrocodone Compared to Acetaminophen and Ibuprofen for Post-nail Procedure Analgesia

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and efficacy of ropivacaine and hydrocodone for nail-procedure associated pain management. The investigators hypothesize that ropivacaine with hydrocodone will be superior to ropivacaine with acetaminophen and ibuprofen for managing pain.

Official Title
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Analysis of Hydrocodone Compared to Acetaminophen and Ibuprofen for Post-nail Procedure Analgesia

Conditions
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Nail Diseases, Nail Abnormality

Intervention / Treatment
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* Drug: Hydrocodone 5Mg/Acetaminophen 325Mg Tab
* Drug: Acetaminophen 1000mg
* Drug: Ibuprofen 400 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing fingernail or toenail, excision, or shave biopsy Must understand and voluntarily sign an informed consent form Must be male or female and aged 18-95 years at time of consent Must be able to adhere to the study visit schedule and other protocol requirements Exclusion Criteria: Subject is unable to provide written informed consent for any reason Subject has peripheral vascular disease, arterial insufficiency, peripheral neuropathy Subject is on Aspirin, NSAIDs, or consumes a chronic medication for control of any other chronic pain Subject has a history of opioid or alcohol use disorder Subject has a history of peptic ulcer disease, gastritis, chronic renal insufficiency or a history of kidney disease, or has underlying liver disease Subject has a history of severe constipation Subject is sensitive or allergic to any of the elements included in this study Subject is unable to complete the required pain dairy Subject is pregnant, planning pregnancy, or nursing

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hydrocodone 5mg/acetaminophen 325mg<br>Participants receive oral hydrocodone 5 mg/acetaminophen 325 mg every 4 hours for 2 days, followed by oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 4 days | Drug: Hydrocodone 5Mg/Acetaminophen 325Mg Tab<br>* 5 mg/325 mg tablet<br>* Other names: Lortab;Drug: Acetaminophen 1000mg<br>* 1000 mg tablet<br>* Other names: Tylenol;Drug: Ibuprofen 400 mg<br>* 400 mg tablet<br>* Other names: Motrin;|
| Active Comparator: Acetaminophen 1000mg + Ibuprofen 400mg<br>Participants receive oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 6 days | Drug: Acetaminophen 1000mg<br>* 1000 mg tablet<br>* Other names: Tylenol;Drug: Ibuprofen 400 mg<br>* 400 mg tablet<br>* Other names: Motrin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Pain Scores on Postoperative Day 2, as Measured by the Wong-Baker 0-to-10 Pain Scale | Change in pain scores obtained with the Wong-Baker 0-to-10 pain scale between the 2 groups on postoperative day 2. The Wong-Baker 0-to-10 pain scale is used for rating the severity of pain, with scores ranging from 0 to 10, and higher scores indicating greater severity of pain. | Baseline, 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Health-related Quality of Life Scores on Postoperative Days 3 and 6, as Measured by an Adapted APS-POQ-R Questionnaire | Change in health-related quality of life associated with pain obtained with an adapted version of the APS-POQ-R (APS Patient Outcome Questionnaire) between the 2 groups on postoperative days 3 and 6. The APS-POQ-R is a questionnaire used for rating health-related quality of life associated with pain, with scores of each domain ranging from 0 to 10 or 0% to 100%, and higher scores indicating greater severity of impact on quality of life (12 domains summed up for total score range of minimum 0 to maximum 120). | 3 days, 6 days (end of study) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nail diseases, nail biopsy, nail procedure, pain management