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

NCT05544734 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 21-10024054
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Nail Diseases; Nail Abnormality

Keywords

nail diseases; nail biopsy; nail procedure; pain management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (2)

Hydrocodone 5mg/acetaminophen 325mg

ACTIVE COMPARATOR

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; Drug: Acetaminophen 1000mg; Drug: Ibuprofen 400 mg

Acetaminophen 1000mg + Ibuprofen 400mg

ACTIVE COMPARATOR

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

Drug: Acetaminophen 1000mg; Drug: Ibuprofen 400 mg

Interventions

Hydrocodone 5Mg/Acetaminophen 325Mg Tab DRUG

5 mg/325 mg tablet

Also known as: Vicodin, Norco, Lortab

Hydrocodone 5mg/acetaminophen 325mg

Acetaminophen 1000mg DRUG

1000 mg tablet

Also known as: Tylenol

Acetaminophen 1000mg + Ibuprofen 400mg; Hydrocodone 5mg/acetaminophen 325mg

Ibuprofen 400 mg DRUG

400 mg tablet

Also known as: Advil, Motrin

Acetaminophen 1000mg + Ibuprofen 400mg; Hydrocodone 5mg/acetaminophen 325mg

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Related Publications (1)

• Hwang JK, Ricardo JW, Lipner SR. Combination of acetaminophen and ibuprofen is noninferior to acetaminophen and hydrocodone for postnail procedure analgesia: A randomized controlled trial. J Am Acad Dermatol. 2023 Dec;89(6):1300-1302. doi: 10.1016/j.jaad.2023.08.042. Epub 2023 Aug 22. No abstract available.

  PMID: 37619705 DERIVED

MeSH Terms

Conditions

Nail Diseases; Nails, Malformed; Agnosia

Interventions

Hydrocodone; Acetaminophen; acetaminophen, hydrocodone drug combination; oxycodone-acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Results Point of Contact

• Title: Dr Shari Lipner
• Organization: Weill Cornell Medicine

shl9032@med.cornell.edu

6469623376

Study Officials

• Shari Lipner, MD, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 16, 2022
• Study Start: November 10, 2022
• Primary Completion: May 15, 2023
• Study Completion: June 1, 2023
• Last Updated: September 28, 2023
• Results First Posted: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)