Nail Diseases, Nail Abnormality
Conditions
Keywords
nail diseases, nail biopsy, nail procedure, pain management
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.
Interventions
5 mg/325 mg tablet
1000 mg tablet
DRUGIbuprofen 400 mg
400 mg tablet
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pain Scores on Postoperative Day 2, as Measured by the Wong-Baker 0-to-10 Pain Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Health-related Quality of Life Scores on Postoperative Days 3 and 6, as Measured by an Adapted APS-POQ-R Questionnaire | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
Hydrocodone 5Mg/Acetaminophen 325Mg Tab: 5 mg/325 mg tablet
Acetaminophen 1000mg: 1000 mg tablet
Ibuprofen 400 mg: 400 mg tablet | 10 |
| Acetaminophen 1000mg + Ibuprofen 400mg Participants receive oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 6 days
Acetaminophen 1000mg: 1000 mg tablet
Ibuprofen 400 mg: 400 mg tablet | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Hydrocodone 5mg/Acetaminophen 325mg | Acetaminophen 1000mg + Ibuprofen 400mg | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 3 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 7 Participants | 13 Participants |
| Age, Continuous | 53.3 years | 47.7 years | 50.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 7 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 6 Participants | 13 Participants |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: Baseline, 2 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydrocodone 5mg/Acetaminophen 325mg | Change From Baseline in Pain Scores on Postoperative Day 2, as Measured by the Wong-Baker 0-to-10 Pain Scale | 2.1 score on a scale | Standard Deviation 1.6 |
| Acetaminophen 1000mg + Ibuprofen 400mg | Change From Baseline in Pain Scores on Postoperative Day 2, as Measured by the Wong-Baker 0-to-10 Pain Scale | 2.4 score on a scale | Standard Deviation 1.7 |
p-value: 0.6995% CI: [-1.85, 1.25]t-test, 2 sided
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).
Time frame: 3 days, 6 days (end of study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydrocodone 5mg/Acetaminophen 325mg | 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 score on a scale | Standard Deviation 11.2 |
| Acetaminophen 1000mg + Ibuprofen 400mg | Change in Health-related Quality of Life Scores on Postoperative Days 3 and 6, as Measured by an Adapted APS-POQ-R Questionnaire | 10.4 score on a scale | Standard Deviation 9 |
p-value: 0.6295% CI: [-7.25, 11.85]t-test, 2 sided