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

Phase 4

Completed

Interventions: Drug: Hydrocodone 5Mg/Acetaminophen 325Mg Tab
Drug: Acetaminophen 1000mg
Drug: Ibuprofen 400 mg

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Hydrocodone 5mg/acetaminophen 325mg	Acetaminophen 1000mg	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
Hydrocodone 5mg/acetaminophen 325mg	Ibuprofen 400 mg	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
Acetaminophen 1000mg + Ibuprofen 400mg	Acetaminophen 1000mg	Participants receive oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 6 days
Acetaminophen 1000mg + Ibuprofen 400mg	Ibuprofen 400 mg	Participants receive oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 6 days
Hydrocodone 5mg/acetaminophen 325mg	Hydrocodone 5Mg/Acetaminophen 325Mg Tab	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

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Pain Scores on Postoperative Day 2, as Measured by the Wong-Baker 0-to-10 Pain Scale	Baseline, 2 days	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.

Secondary Outcome Measures

Name	Time	Method
Change in Health-related Quality of Life Scores on Postoperative Days 3 and 6, as Measured by an Adapted APS-POQ-R Questionnaire	3 days, 6 days (end of study)	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).