Phase 4
N=20
Hydrocodone Compared to Acetaminophen and Ibuprofen for Post-nail Procedure Analgesia
Nail Diseases · Nail Abnormality
Bottom Line
View on ClinicalTrials.gov: NCT05544734 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Change From Baseline in Pain Scores on Postoperative Day 2, as Measured by the Wong-Baker 0-to-10 Pain Scale — 2.1; 2.4 score on a scale — p=0.69
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Hydrocodone 5Mg/Acetaminophen 325Mg Tab (Drug); Acetaminophen 1000mg (Drug); Ibuprofen 400 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Pain Scores on Postoperative Day 2, as Measured by the Wong-Baker 0-to-10 Pain Scale |
2.1; 2.4 | 0.69 |
| SECONDARY Change in Health-related Quality of Life Scores on Postoperative Days 3 and 6, as Measured by an Adapted APS-POQ-R Questionnaire |
12.7; 10.4 | 0.62 |
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.
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
Data sourced from ClinicalTrials.gov (NCT05544734). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.