Conditions: Hip Arthroscopy
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 100
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Acetaminophen intervention 2: Percocet
Intervention descriptions: intervention 1: acetaminophen 600 mg to be taken every 8 hours (TID) intervention 2: 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

Protocol document:
Prot_SAP_000.pdf: 
Acetaminophen vs. Narcotics After Hip Arthroscopy 
 
 
 
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Multimodal Analgesia with Acetaminophen vs. Narcotics Alone After Hip Arthroscopy 
  
 
 
 
Regulatory Sponsor: 
Department of Orthopaedic Surgery 
301 E. 17th Street 
New York, NY 10003 
Principal Investigator: 
Thomas Youm, MD 
Division of Sports Medicine 
New York University Hospital for Joint Diseases 
New York, NY 10003 
Office: (212) 348-3636 
 
 
 
Protocol Number: 
18-00167 
NCT Number: 
NCT03510910  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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I. PURPOSE OF THE STUDY AND BACKGROUND 
Purpose 
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.  
 
We hypothesize that the majority of patients, following hip arthroscopy, forego their prescribed 
narcotic medication and, instead, are able to adequately control their post-operative pain with 
acetaminophen.  
 
Rationale 
Many studies have highlighted the impact of physicians’ propensity to over-prescribe opioid 
analgesics in the United States.(1-5) While orthopaedic surgeons prescribe opioid analgesics at the 
third highest rate in the U.S.,(6) some believe these mostly go unused and end up being 
improperly stored in patients’ homes(1). This data encourages us to critically evaluate the 
necessity of these prescriptions for common outpatient procedures such as hip arthroscopy.  
 
The current standard post-operative medications for patients after hip arthroscopy consists of a 
narcotic analgesic such as oxycodone/acetaminophen (Percocet) for pain along with two non-
steroidal anti-inflammatory drugs (NSAIDs) – aspirin for DVT prophylaxis and celecoxib for 
heterotopic ossification prophylaxis. It is known that NSAIDs have the ability to reduce the 
inflammatory processes associated with the body’s physiological response to surgical trauma, 
specifically the cyclooxygenase (COX) inflammatory pathway.  
 
If surgeons can reduce the amount of narcotic analgesics prescribed after hip arthroscopy while 
effectively managing post-operative pain with acetaminophen, aspirin and celecoxib, this can 
reduce overall narcotic use and, therefore, reduce the incidence of adverse events and addiction 
commonly associated with narcotics. 
 
Study Design 
This will be a single-center, randomized prospective study. The study will compare post-
operative pain scores and narcotic consumption between two cohorts – one cohort will receive 
acetaminophen along with a reduced quantity of Percocet (to be used as needed for breakthrough 
pain) and the other cohort will receive 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.  
 
Primary Objective 
The primary objectives 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.  
 
II. CHARACTERISTICS OF THE RESEARCH POPULATION 
Number of Subjects 


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We will aim to enroll a total of 100 subjects (50 per cohort).  
 
Gender of Subjects  
Men and women will be included in this study. 
 
Age of Subjects 
Subjects included study will be at least 18 years of age, but less than 65. 
 
Racial and Ethnic Origin 
There are no enrollment restrictions based on race or ethnic origin. 
 
Inclusion Criteria 
All study subjects must meet the following inclusion criteria: 
• Must be at least 18 years of age 
• ASA class I-II 
• Patients indicated and scheduled for arthroscopic hip surgery 
 
Exclusion Criteria 
Patients meeting the following criteria will be excluded from participation in this study: 
• 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 
 
Vulnerable Subjects 
We do not intend to enroll vulnerable subjects. 
 
Subject withdrawal criteria.   
Patients are free to withdraw at any time from the study.   
 
III. METHODS AND PROCEDURES 
Methods and Procedures  
Patients indicated and scheduled for hip arthroscopy will be identified by participating 
orthopaedic surgeons at NYU Langone Orthopedic Hospital. After informed consent is obtained, 
a chart review of patients’ medications and past medical histories will be performed based on 
their electronic medical records to identify any current pain medications or exclusion criteria. 
Patients will then be randomized to one of two cohorts based on patients’ medical record number 
(MRN):  
- 
MRN ending in an EVEN #: will receive acetaminophen 600 mg to be taken every 8 
hours (TID) and oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for 
breakthrough pain. These patients should only take 3 Tylenol within a 24 hour period and 
2 Percocet within 24 hours.. 


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MRN ending in an ODD #: will receive the current standard of care postoperative pain 
management, which is Percocet 5 mg/325 mg every 6 hours PRN.  
Both pain management options are considered to be standard of care and the patient would be 
able to receive either option regardless of study participation. Immediate post-operative 
management will not be affected by this study. All patients will receive a standardized regimen 
of aspirin for DVT prophylaxis and celecoxib for heterotopic ossification prophylaxis, which is 
standard of care post-operative treatment. As the study focuses on the first week post-
operatively, both cohorts will equally experience limitations in mobility. The Acetaminophen 
cohort should not have more mobility or recovery issues than the Percocet cohort.  
 
Information to be recorded pre-operatively includes age, sex, height, weight, BMI, and American 
Society of Anesthesiology (ASA) classification. Intra-operative information will also be 
recorded, including operative time, and intraoperative morphine-equivalent doses. Pain severity 
scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain 
imaginable) at 0.5, 1, 1.5, 2, 4, 6, 24, and 48 hours as well as 7 days after surgery. Morphine-
equivalent consumption will be recorded immediately after surgery, during phase II recovery, 
and at 24 hours, 2 days and 7 days after surgery. Incidence of narcotic-related side effects 
(nausea/vomiting, itching, constipation) in the first 24 hours will be noted. Time to discharge 
from the post-anesthesia care unit (PACU) and time to discharge from the hospital will be 
recorded.  
 
Patients will be given a journal to record their pain scores throughout their first week after 
surgery. They will record whether they used any Percocet and, if so, the daily amounts. Patients 
in the Acetaminophen cohort will be advised to take Percocet if they are experiencing distressing 
pain, a 5 on the VAS scale. Distressing pain is defined as pain that is not alleviated with 
Acetaminophen and cannot be ignored. This journal will be collected during the patient’s 
standard 1-week post-operative checkup along with their bottle of prescription medication, which 
will also be recorded. Patients will be advised to seek medical attention if they experience any 
adverse events, including nausea, vomiting, dizziness, drowsiness, and stomach disturbances, or 
continue to have uncontrolled pain.  
 
Data Analysis and Statistical Plan 
In order to determine sample size an a priori power analysis was conducted to estimate the 
minimum sample size needed to achieve 80% power (1 – b) at the .05 significance level for the 
primary outcome measure, VAS score. Variables used in the power calculation were taken from 
the literature including an assumed effect size of 2.5 and standard deviation (SD) of 2. This 
analysis suggested that a minimum of 28 patients per group would suffice. To allow room for 
potential loss to follow-up and to ensure a robust data set, we will aim to enroll a total of 100 
subjects (50 per cohort). We will use patient subjective pain and narcotic consumption data as 
statistical endpoints. 
 
Statistical analysis will be performed using t-tests for continuous variables, and chi-square tests 
for categorical ones.  If the data is not normally distributed, Mann-Whitney tests will be used.  
All protected health information will be removed prior to statistical analysis.   
 
Data and Safety Monitoring Plan 


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Data monitoring will be done by Dr. Thomas Youm, the principal investigator and individual 
medical monitor..  They will review the following points quarterly.   
They will monitor whether or not: 
1. Collection and storage of patient data was performed in a sensitive and secure 
manner, as defined in the informed consent form and protocol 
2. All study activities were conducted with primary emphasis on patient care and 
wellbeing 
3. If there were any adverse events, and if so were addressed appropriately and per 
protocol  
4. The risk/benefit to patients has remained the same throughout the course of the study 
The study will be stopped if there are unexpected severe AE’s in more than one patient. Adverse 
events will be defined as negative reactions to the NSAIDs or Percocet including a 
hypersensitivity reaction or drug dermatological eruption. We will submit summaries of data and 
safety monitoring bi-annually.   
 
Data Storage and Confidentiality 
Data recorded from this study will be organized in REDCap. Participant medical information 
will only be available to the principal investigator and research staff as necessary for data 
analysis. All patient health information will be de-identified and assigned a code. Information 
linking participants’ names, social security numbers and medical record numbers will be stored 
in a secure location separate from the medical information. No data will be shared to anyone 
outside of the study team.  
 
Adverse Event Reporting 
Information about any breach of confidentiality will be documented in the electronic data 
collection system and/or on the paper CRFs, as appropriate. It will be the responsibility of the 
Principal Investigator to report any Serious Adverse Event (SAE) that occurs during the course 
of the retrospective data collection to the Institutional Review Board (IRB) within the timeframe 
specified by NYU SoM.   
 
Adverse events will be defined as negative reactions to the NSAIDs or Percocet including a 
hypersensitivity reaction or drug dermatological eruption.  Patients will be instructed to call 
immediately if they have an issue.  Additionally, they will be coming to the hospital the day after 
taking the drug when they will be further evaluated.  Subjects will be evaluated by the operating 
physician prior to the procedure.  After the procedure, patients will have post-operative visits 
(standard of care) when they may be further evaluated for AEs.  Given the immediacy of AEs in 
this case, the timeframe will be limited to the first post-op visit (10-14 days after initial 
medication ingestion).   
 
IV. RISK/BENEFIT ASSESSMENT 
Risk 
Because this study involves the standard of care for post-operative hip arthroscopy pain 
management, the risks are minimal and include a risk of breach of confidentiality. Together, 
acetaminophen and Percocet have not shown to have an adverse drug interaction. However, each 
medication carries its’ own side effects. Acetaminophen may cause an allergic reaction. 
Symptoms may include: itching or hives, swelling or tingling in your mouth or throat, swelling 


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of your face or hands, tightness of the chest, trouble breathing. Other serious side effects of 
acetaminophen may include: nausea, vomiting, loss of appetite, or severe stomach pain, trouble 
passing urine or change in the amount of urine, light-headedness, sweating, fainting, or 
weakness, unusual bruising or bleeding, yellowing of the skin or whites of your eyes. Percocet 
may cause side effects such as constipation, nausea, vomiting, upset stomach, sleepiness, 
drowsiness, dizziness, lightheadedness, itching, headache, blurred vision, dry mouth, and 
sweating. Percocet contains oxycodone, which is an opioid. There is a less than 5% chance 
patients who take opioids for a short period of time (<2 weeks) have a risk of developing a 
physical dependence or of becoming addicted. 
 
These side effects are more likely if Acetaminophen or Percocet are if taken with alcohol or 
grapefruit juice. The risks and side effects of the medications will be discussed with the patients 
prior to surgery and the standard post-operative follow up visits.   
 
Protection against Risks  
Patients will be screened for any contraindication to acetaminophen or Percocet use. 
 
Additionally, all patients will be de-identified and given a code. Information linking the patient 
codes to the participants’ names and medical record numbers will be stored in a secure location 
separate from the medical information.  Access to the information linking the linkage codes with 
participant identifiers shall be restricted.   
 
Potential Benefits to the Subjects  
Patients may experience less pain post-operatively, and may require less narcotics use, which has 
a steeper side-effect profile. However, these benefits cannot be guaranteed. 
 
Additionally, it is the hope of the research team that results of this study will benefit future 
patients and their physicians by providing more information regarding the use of acetaminophen 
after surgery.  This will allow for a more open and informed dialogue, and possibly a change in 
treatment.  
 
V. INVESTIGATOR’S QUALIFICATIONS AND EXPERIENCE 
The CV, medical license, and human subjects’ tutorial completion report are attached for all 
investigators who are participating in this study.  All research personnel have medical research 
experience and are qualified to participate in this quality study. Most importantly, staff have been 
properly educated and certified with CITI training to conduct research in a matter that will 
maintain full patient confidentiality. The research coordinator for this study is trained in GCP 
principles and practices and will be responsible for compliance with GCP guidelines for all study 
investigators and research assistants. 
 
VI. SUBJECT IDENTIFICATION, RECRUITMENT AND CONSENT/ASSENT 
Method of Subject Identification and Recruitment 
Appropriate patients, who meet all of the inclusion criteria and none of the exclusion criteria, 
who require a hip arthroscopy, will be identified from the clinical offices of the investigator 
surgeons.  
 


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Process of Consent 
Written consent will be obtained from subjects who are eligible candidates for hip arthroscopy 
based upon their medical condition (as determined by their physician). The consent process will 
take place during the office visit when it is determined necessary to perform the procedure—at 
which time the investigator has determined subject’s voluntary participation has been upheld. 
Subjects will be informed about the study and the intended purpose. They will be given the 
opportunity to ask questions and receive thorough explanations. They will be made aware of the 
possible risks and anticipated benefits. They will also be informed of alternative procedures. 
Subjects will then be given another opportunity to ask questions and agree or disagree to consent. 
 
Subject Capacity 
All subjects enrolled in this study will have capacity to provide informed consent. 
 
Consent Forms 
Written consent will be obtained from the patient. 
 
Documentation of Consent 
Signed consent forms will be kept in a binder and stored in a locked file cabinet.   
 
Costs to the Subject 
Subjects will not incur any additional financial costs as a participant in this study. 
 
Payment for Participation  
No payments/reimbursements will be provided to subjects for their participation in this study. 
 
Clinical Trial 
 A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This 
Web site will not include information that can identify you. At most, the Web site will include a summary of the 
results. You can search this Web site at any time. 
 
VII. References 
 
1. 
Morris BJ, Mir HR. The opioid epidemic: impact on orthopaedic surgery. J Am Acad 
Orthop Surg. 2015;23(5):267-71. 
2. 
O'Neill DF, Webb Thomas C. Less is more: limiting narcotic prescription quantities for 
common orthopedic procedures. Phys Sportsmed. 2014;42(4):100-5. 
3. 
Paulozzi LJ, Budnitz DS, Xi Y. Increasing deaths from opioid analgesics in the United 
States. Pharmacoepidemiol Drug Saf. 2006;15(9):618-27. 
4. 
Paulozzi LJ, Xi Y. Recent changes in drug poisoning mortality in the United States by 
urban-rural status and by drug type. Pharmacoepidemiol Drug Saf. 2008;17(10):997-1005. 
5. 
Rodgers J, Cunningham K, Fitzgerald K, Finnerty E. Opioid consumption following 
outpatient upper extremity surgery. J Hand Surg Am. 2012;37(4):645-50. 
6. 
Volkow ND, McLellan TA, Cotto JH, Karithanom M, Weiss SR. Characteristics of opioid 
prescriptions in 2009. JAMA. 2011;305(13):1299-301.