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

Nail Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05544734
• Other study ID #: 21-10024054
• Status: Completed
• Phase: Phase 4
• Start date: November 10, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: September 2023
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 1, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Nail Abnormality
• Nail Diseases

Intervention

Drug:
• Hydrocodone 5Mg/Acetaminophen 325Mg Tab
5 mg/325 mg tablet
• Acetaminophen 1000mg
1000 mg tablet
• Ibuprofen 400 mg
400 mg tablet

Locations

Country	Name	City	State
United States	Weill Medical College of Cornell University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	3 days, 6 days (end of study)