Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this proposed study is to evaluate the efficacy of a multimodal approach to analgesia for patient's pain after hip arthroscopy and to also assess if this new approach will result in a reduction in post-operative narcotic use.
This study is a single-center, randomized prospective study comparing post-operative pain scores and narcotic consumption between individuals receiving acetaminophen along with a reduced quantity of Percocet (to be used as needed for breakthrough pain) and individuals receiving Percocet only. Both pain management options are considered to be standard of care. Both cohorts will receive aspirin for DVT prophylaxis and celecoxib for heterotopic ossification prophylaxis.
The primary objective of the study are to compare patients' narcotic consumption and reported pain following arthroscopic hip surgery, and determine if acetaminophen can provide adequate pain relief compared to a narcotic medication.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetaminophen along with a reduced quantity of Percocet | Experimental |
| |
| Percocet only | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | acetaminophen 600 mg to be taken every 8 hours (TID) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction | Satisfaction was reported on a Likert-type scale of 1-10 (the higher the score, the higher the satisfaction) | 7 days post-surgery |
| Morphine-equivalent Consumption | Amount of oxycodone/acetaminophen (Percocet) in 5mg/325mg doses will be recorded in number of pills | 7 days post-surgery |
| Score on Visual Analog Scale (VAS) of Pain | Pain severity scores at rest will be assessed by use of VAS. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The higher the score, the worse the pain. | 24 hours post-surgery |
| Score on Visual Analog Scale (VAS) of Pain | Pain severity scores at rest will be assessed by use of VAS. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The higher the score, the worse the pain. | 4 days post-surgery |
| Score on Visual Analog Scale (VAS) of Pain | Pain severity scores at rest will be assessed by use of VAS. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The higher the score, the worse the pain. | 7 days post-surgery |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas Youm, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Acetaminophen Along With a Reduced Quantity of Percocet | Acetaminophen: acetaminophen 600 mg to be taken every 8 hours (TID) Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group. Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN |
| FG001 | Percocet Only | Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group. Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Acetaminophen Along With a Reduced Quantity of Percocet | Acetaminophen: acetaminophen 600 mg to be taken every 8 hours (TID) Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group. Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Satisfaction | Satisfaction was reported on a Likert-type scale of 1-10 (the higher the score, the higher the satisfaction) | Posted | Mean | Standard Deviation | score on a scale | 7 days post-surgery |
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acetaminophen Along With a Reduced Quantity of Percocet | Acetaminophen: acetaminophen 600 mg to be taken every 8 hours (TID) Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group. Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Youm, MD | NYU Langone Health | 212-348-3636 | Thomas.Youm@nyulangone.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 15, 2018 | Dec 11, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| C514822 | oxycodone-acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Percocet | Drug | Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group. Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN |
|
| BG001 |
| Percocet Only |
Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group. Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Morphine-equivalent Consumption | Amount of oxycodone/acetaminophen (Percocet) in 5mg/325mg doses will be recorded in number of pills | Posted | Mean | Standard Deviation | pills | 7 days post-surgery |
|
|
|
| Primary | Score on Visual Analog Scale (VAS) of Pain | Pain severity scores at rest will be assessed by use of VAS. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The higher the score, the worse the pain. | Posted | Mean | Standard Deviation | score on a scale | 24 hours post-surgery |
|
|
|
| Primary | Score on Visual Analog Scale (VAS) of Pain | Pain severity scores at rest will be assessed by use of VAS. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The higher the score, the worse the pain. | Posted | Mean | Standard Deviation | score on a scale | 4 days post-surgery |
|
|
|
| Primary | Score on Visual Analog Scale (VAS) of Pain | Pain severity scores at rest will be assessed by use of VAS. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The higher the score, the worse the pain. | Posted | Mean | Standard Deviation | score on a scale | 7 days post-surgery |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Percocet Only | Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group. Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN | 0 | 40 | 0 | 40 | 0 | 40 |
Not provided
Not provided
Not provided
| Aniline Compounds |
| D000588 | Amines |