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

Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05544734
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Hydrocodone 5Mg/Acetaminophen 325Mg Tab
  • Drug: Acetaminophen 1000mg
  • Drug: Ibuprofen 400 mg
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Analysis of Hydrocodone Compared to Acetaminophen and Ibuprofen for Post-nail Procedure Analgesia
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Hydrocodone 5mg/acetaminophen 325mg

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
5 mg/325 mg tablet
Other Names:
  • Vicodin
  • Norco
  • Lortab

    • Drug: Acetaminophen 1000mg
    1000 mg tablet
    Other Names:
  • Tylenol

    • Drug: Ibuprofen 400 mg
    400 mg tablet
    Other Names:
  • Advil
  • Motrin

    		•
    Active Comparator: Acetaminophen 1000mg + Ibuprofen 400mg

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

    Drug: Acetaminophen 1000mg
    1000 mg tablet
    Other Names:
  • Tylenol

    • Drug: Ibuprofen 400 mg
    400 mg tablet
    Other Names:
  • Advil
  • Motrin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    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)]

      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 item ranging from 0 to 10 or 0% to 100%, and higher scores indicating greater severity of impact on quality of life.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 95 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Weill Medical College of Cornell University New York New York United States 10021

    Sponsors and Collaborators

    • Weill Medical College of Cornell University

    Investigators

    • Principal Investigator: Shari Lipner, MD, PhD, Weill Medical College of Cornell University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Weill Medical College of Cornell University
    ClinicalTrials.gov Identifier:
    NCT05544734
    Other Study ID Numbers:
    • 21-10024054
    First Posted:
    Sep 16, 2022
    Last Update Posted:
    Sep 16, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Weill Medical College of Cornell University
    nail diseases
    nail biopsy
    nail procedure
    pain management
    Additional relevant MeSH terms:
    Nail Diseases
    Nails, Malformed
    Acetaminophen
    Ibuprofen
    Hydrocodone

    Study Results

    No Results Posted as of Sep 16, 2022