Hip Arthroscopy
Conditions
Brief summary
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.
Interventions
DRUGAcetaminophen
acetaminophen 600 mg to be taken every 8 hours (TID)
DRUGPercocet
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
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* ASA class I-II * Patients indicated and scheduled for arthroscopic hip surgery
Exclusion criteria
* Contraindication to acetaminophen or oxycodone/acetaminophen (e.g. hypersensitivity, history of GI or bleeding disorder) * Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.) * Younger than 18 years of age or older than 65 * Any patient considered a vulnerable subject * Patients on pain medication prior to surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 7 days post-surgery | Satisfaction was reported on a Likert-type scale of 1-10 (the higher the score, the higher the satisfaction) |
| Morphine-equivalent Consumption | 7 days post-surgery | Amount of oxycodone/acetaminophen (Percocet) in 5mg/325mg doses will be recorded in number of pills |
| Score on Visual Analog Scale (VAS) of Pain | 24 hours post-surgery | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 40 |
| 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 | 40 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Incomplete Survey | 2 | 3 |
Baseline characteristics
| Characteristic | Percocet Only | Total | Acetaminophen Along With a Reduced Quantity of Percocet |
|---|---|---|---|
| Age, Continuous | 40.2 years STANDARD_DEVIATION 16.5 | 39.82 years STANDARD_DEVIATION 14.8 | 39.43 years STANDARD_DEVIATION 13.1 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 40 participants | 80 participants | 40 participants |
| Sex: Female, Male Female | 22 Participants | 46 Participants | 24 Participants |
| Sex: Female, Male Male | 18 Participants | 34 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Morphine-equivalent Consumption
Amount of oxycodone/acetaminophen (Percocet) in 5mg/325mg doses will be recorded in number of pills
Time frame: 7 days post-surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acetaminophen Along With a Reduced Quantity of Percocet | Morphine-equivalent Consumption | 6.33 pills | Standard Deviation 7.1 |
| Percocet Only | Morphine-equivalent Consumption | 5.69 pills | Standard Deviation 5.8 |
Primary
Patient Satisfaction
Satisfaction was reported on a Likert-type scale of 1-10 (the higher the score, the higher the satisfaction)
Time frame: 7 days post-surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acetaminophen Along With a Reduced Quantity of Percocet | Patient Satisfaction | 8.48 score on a scale | Standard Deviation 1.52 |
| Percocet Only | Patient Satisfaction | 8.83 score on a scale | Standard Deviation 1.55 |
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.
Time frame: 24 hours post-surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acetaminophen Along With a Reduced Quantity of Percocet | Score on Visual Analog Scale (VAS) of Pain | 5.30 score on a scale | Standard Deviation 2.02 |
| Percocet Only | Score on Visual Analog Scale (VAS) of Pain | 4.98 score on a scale | Standard Deviation 2.24 |
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.
Time frame: 4 days post-surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acetaminophen Along With a Reduced Quantity of Percocet | Score on Visual Analog Scale (VAS) of Pain | 3.55 score on a scale | Standard Deviation 1.68 |
| Percocet Only | Score on Visual Analog Scale (VAS) of Pain | 3.20 score on a scale | Standard Deviation 1.98 |
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.
Time frame: 7 days post-surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acetaminophen Along With a Reduced Quantity of Percocet | Score on Visual Analog Scale (VAS) of Pain | 3.20 score on a scale | Standard Deviation 1.79 |
| Percocet Only | Score on Visual Analog Scale (VAS) of Pain | 2.83 score on a scale | Standard Deviation 2.11 |