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

Weill Medical College of Cornell University20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nail Diseases Nail Abnormality

Interventions

Hydrocodone 5Mg/Acetaminophen 325Mg TabDRUG

5 mg/325 mg tablet

Acetaminophen 1000mgDRUG

1000 mg tablet

Ibuprofen 400 mgDRUG

400 mg tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 Years

Medical Language ↔ Plain English

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

Locations (1)

Weill Medical College of Cornell University

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 2 days

Secondary Outcomes

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).

Time frame: 3 days, 6 days (end of study)

Data from ClinicalTrials.gov

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