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

Primary Purpose

Nail Diseases, Nail Abnormality

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Hydrocodone 5Mg/Acetaminophen 325Mg Tab

Acetaminophen 1000mg

Ibuprofen 400 mg

About this trial

This is an interventional treatment trial for Nail Diseases focused on measuring nail diseases, nail biopsy, nail procedure, pain management

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Weill Medical College of Cornell University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Hydrocodone 5mg/acetaminophen 325mg

Acetaminophen 1000mg + Ibuprofen 400mg

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT05544734

First Posted

September 13, 2022

Last Updated

September 25, 2023

Sponsor

Weill Medical College of Cornell University

1. Study Identification

Unique Protocol Identification Number

NCT05544734

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

November 10, 2022 (Actual)

Primary Completion Date

May 15, 2023 (Actual)

Study Completion Date

June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nail Diseases, Nail Abnormality

Keywords

nail diseases, nail biopsy, nail procedure, pain management

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hydrocodone 5mg/acetaminophen 325mg

Arm Type

Active Comparator

Arm Description

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

Arm Title

Acetaminophen 1000mg + Ibuprofen 400mg

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Hydrocodone 5Mg/Acetaminophen 325Mg Tab

Other Intervention Name(s)

Vicodin, Norco, Lortab

Intervention Description

5 mg/325 mg tablet

Intervention Type

Drug

Intervention Name(s)

Acetaminophen 1000mg

Other Intervention Name(s)

Tylenol

Intervention Description

1000 mg tablet

Intervention Type

Drug

Intervention Name(s)

Ibuprofen 400 mg

Other Intervention Name(s)

Advil, Motrin

Intervention Description

400 mg tablet

Primary Outcome Measure Information:

Title

Change From Baseline in Pain Scores on Postoperative Day 2, as Measured by the Wong-Baker 0-to-10 Pain Scale

Description

Time Frame

Baseline, 2 days

Secondary Outcome Measure Information:

Title

Change in Health-related Quality of Life Scores on Postoperative Days 3 and 6, as Measured by an Adapted APS-POQ-R Questionnaire

Description

Time Frame

3 days, 6 days (end of study)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shari Lipner, MD, PhD

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Weill Medical College of Cornell University

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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