Skip to main content
OpenTrials
Completed

NCT Number: NCT05544734

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nail Diseases Agnosia Nail Abnormality Nails, Malformed Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Weill Medical College of Cornell University

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrocodone 5Mg/Acetaminophen 325Mg Tab

Drug

5 mg/325 mg tablet

Other names: Vicodin, Norco, Lortab

Acetaminophen 1000mg

Drug

1000 mg tablet

Other names: Tylenol

Ibuprofen 400 mg

Drug

400 mg tablet

Other names: Advil, Motrin

Primary outcomes

  1. 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.

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

    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).

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 16, 2022
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.