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

September 25, 2023 updated by: Weill Medical College of Cornell University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Weill Medical College of Cornell University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Pain Scores on Postoperative Day 2, as Measured by the Wong-Baker 0-to-10 Pain Scale
Time Frame: 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.
Baseline, 2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Health-related Quality of Life Scores on Postoperative Days 3 and 6, as Measured by an Adapted APS-POQ-R Questionnaire
Time Frame: 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 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).
3 days, 6 days (end of study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2022

Primary Completion (Actual)

May 15, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

September 13, 2022

First Submitted That Met QC Criteria

September 13, 2022

First Posted (Actual)

September 16, 2022

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-10024054

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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