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

Weill Cornell Medicine (WCM)

Status and phase: Completed; Phase 4

Conditions: Nail Abnormality; Nail Diseases

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05544734

21-10024054

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Hydrocodone 5mg/acetaminophen 325mg

Active Comparator group

Description:

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

Treatment:

Drug: Hydrocodone 5Mg/Acetaminophen 325Mg Tab

Drug: Ibuprofen 400 mg

Drug: Acetaminophen 1000mg

Acetaminophen 1000mg + Ibuprofen 400mg

Active Comparator group

Description:

Participants receive oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 6 days

Treatment:

Drug: Ibuprofen 400 mg

Drug: Acetaminophen 1000mg