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

21-10024054

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.

2022-11-10

2023-05-15

2023-06-01

Completed

Early phase I

20

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}

2023-09-28