Randomized Control Trial of the Impact of a Virtual Psychological Intervention on the Outcomes of ACLR
Phase: NA
Conditions: Depression, Anterior Cruciate Ligament Injuries, Mental Health Issue
Sponsor: Henry Ford Health System

Protocol Version #1   
Date: 9/19/2023 
 
 
 
 
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy: A 
Prospective Randomized Controlled Trial 
 
NCT05965310 
Date: 03/17/2024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol Version #1   
Date: 9/19/2023 
 
STUDY TITLE: Efficacy of Ketorolac for Postoperative Pain Management in Hip 
Arthroscopy: A Prospective Randomized Controlled Trial 
 
1. STUDY AIM, BACKGROUND, AND DESIGN ABSTRACT  
 
The purpose of this study is to investigate the use of alternative pain management protocols for 
controlling post-operative pain in patients undergoing hip arthroscopy. Hip arthroscopy (HA) is commonly used 
to treat patients with femoroacetabular impingement (FAI), trochanteric pain syndrome, snapping hip disorders, 
and young adult hip disorders 1. Previous protocols for perioperative pain management of hip arthroscopy have 
included opioids for pain management, however, with the increasing severity of the opioid epidemic in the 
United States, it is important to find other means for treating pain post-operation. The use of opioids have been 
shown to subject patients to a greater chance of addiction, depression, and anxiety and it has been found that 
patients who required one refill on their post-operative opioid medication were likely to have a lower baseline 
patient recorded outcomes and achieved patient acceptable symptomatic state (PASS) at lower rates 
compared to those who did not. 2It is important to find alternatives to opioid pain treatment for pre/post-
operative hip arthroscopy to improve patient outcomes. 
 
Current alternative pain treatments for HA include multimodal strategies combining NSAIDs with 
opioids. 3 Kahlenburg et al found that patients who were administered 400mg of celecoxib (NSAID) 1 hour 
before surgery had significantly lower VAS pain scores after surgery as well as reduced opioid consumption 
and hospital stay compared to those who were not. Gabapentin and acetaminophen have also been found to 
reduce opioid consumption post-surgery 4. There has been success with entirely non-opioid pain protocols for 
arthroscopic surgeries. 5 Jildeh et al found that a multimodal non-opioid pain protocol post-operatively was 
better or equivalent at pain control than the traditional opioid protocol which used oxycodone for arthroscopic 
rotator cuff surgery. 6 Moutzouros et al also found that a multimodal pain protocol without opioids was 
equivalent to or better than an opioid-only postoperative pain plan in anterior cruciate ligament (ACL) 
reconstruction. Previous studies have assessed the impact of ketorolac on rotator cuff repair and ACL 
reconstruction and found improved pain scores postoperatively4, 5,6,7. 
We propose testing the efficacy of ketorolac-based multimodal pain management protocol in patients at 
one institution undergoing hip arthroscopy and comparing the results to the current facility protocols. Variables 
for comparison will be a 5-day pain journal assessment, VAS, PROMIS scores collected at follow-up 
appointments, and postoperative opioid consumption. Subjects will be randomly assigned to a control group 
and a non-opioid pain group. The control group will be given the typical regimen of hydrocodone-
acetaminophen and diazepam while the study cohort will receive ketorolac in addition. We hypothesize that the 
ketorolac pain management protocol will be just as effective as or better than the current standard of care in 
reducing immediate post-operative pain and opioid consumption. Finding an alternative to opioid pain relief is 
vital to providing the best patient care and outcomes post hip arthroscopy. 
 
2. SUBJECT POPULATION AND ELIGIBILITY 
 
    
Subject Population 
 
The participants will be selected from those who are undergoing hip arthroscopy at Henry Ford Health 
System in Detroit, Michigan. Participants will include males and females over the age of 18.  
 
 
Exclusion Criteria 
Inclusion Criteria 
Patients with inability to consent and/or do not 
speak English  
Patients undergoing hip arthroscopy over the 
age of 18 with Dr. T. Sean Lynch 

Protocol Version #1   
Date: 9/19/2023 
 
Patients with conditions contraindicated with 
NSAIDs (medication allergy, peptic ulcer disease, 
bleeding diathesis, and renal disease)  
 
 
Patients with history of drug and alcohol use 
disorder 
 
Patients with chronic analgesia (filled two opioid 
prescriptions within 6 months of the surgery) 
 
Patients with psychotropic medication usage 
 
Patients who take pentoxifylline, probonecid, 
aspirin, and/or NSAIDs who cannot stop taking it 
for the study 
 
Patients who are not discharged same day after 
surgery 
 
 
 
Enrollment and/or Screening 
• 
Consecutive patients on Dr. T. Sean Lynch’s clinic schedule will be reviewed for qualifying patients 
as well as potential study participant medical records to ensure inclusion and exclusion criteria are 
met. This will be performed by study personnel only.  
• 
In order to ensure criteria is met and potential participants have no contraindications to ketorolac 
their medical history and medical chart will need to be reviewed 
• 
Criteria will be reviewed beforehand for prospective patients and then with the patient to ensure 
they are appropriate for the study.  
• 
Only patients from Dr. T Sean Lynch’s clinic will be included 
• 
If patients were to fail screening they will not be eligible for the study and will not be enrolled. They 
will continue with the standard of care medications. If the patient decides not to have surgery or are 
not discharged home POD0 after surgery will be removed from the study.  
 
 
 
3. STUDY PROCEDURES 
 
A prospective randomized controlled trial to study the effects of ketorolac as an adjunct for 
postoperative pain management after hip arthroscopy. Eligible participants will be randomly assigned to 
two groups. At discharge, the control group will receive the standard of care pain protocol at our 
institution. The ketorolac group (experimental group) will receive the standard of care pain protocol 
along with an intraoperative loading dose of IV ketorolac, a prescription of ketorolac (10mg by mouth 
every 6 hours for 3 days, and omeprazole (20 mg by mouth once daily for 3 days) for gastrointestinal 
prophylaxis on discharge. The standard of care pain protocol is hydrocodone-acetaminophen 
5mg/325mg and diazepam 5mg. On POD0 both groups will be given a journal to record their pain levels 
during the 5 days after surgery as well as adverse effects to medication such as nausea, abdominal 
pain, allergic reaction, dark stool, dry mouth, fever, headaches, cough, gastritis, drowsiness, and 
insomnia. VAS and narcotic consumption will be measured for 5 days via the journal as well as 2 and 6 
weeks post-operative. PROMIS PF and PI scores will be recorded preoperatively, 2 weeks, 6 weeks, 
and 3 months post-operatively. 
 
Our primary outcome is VAS at POD4. Based on previous studies using visual analog scale pain 
scores for hip arthroscopy, a difference of 1-3 was considered significant for most patients3,7. Therefore, 
we determined via a priori analysis that we needed to enroll 80 patients (40 patients in each cohort) to 
detect a VAS difference of 2 assuming standard deviation of 3, alpha of 0.05, power of 0.8, and drop 
out of 10%.  
 
Randomization after consent will be performed by a research assistant with a 1:1 allocation ratio using 

Protocol Version #1   
Date: 9/19/2023 
 
adaptive randomization computer software (Adaptive Randomization; MD Anderson Cancer Center). At 
1 week before surgery, appropriate surgeon, physician assistant, anesthesiologist, and/or resident 
physician will be notified by secure email of the patient’s group designation.  
 
Summary statistics using mean and standard deviation for continuous variables and frequency 
(percentage) for categorical variables. Mann-Whitney U tests will be used to correct for any non-
normality. Statistical differences in patients’ characteristics will be examined with univariate analysis. 
Chi square tests for categorical variables and Student t-tests for continuous variables will be used to 
compare the control and experimental cohort. Statistical significance will be defined with a P value of 
0.05, and all tests will be two-sided tests using statistical software SPSS. 
 
 
 
Control 
hydrocodone-
acetaminophen 
5mg/325mg 1 
tablet q6hrs 
PRN to start on 
POD0 
 
30 tablets 
indomethacin 
75mg 1 tablet 
QD to start on 
POD0 
 
 
 
10 tablets 
diazepam 
5mg 1-2 
tablets q8hrs 
PRN to start 
on POD0 
 
 
15 tablets 
 
 
Experimental 
hydrocodone-
acetaminophen 
5mg/325mg 1 
tablet q6hrs 
PRN to start on 
POD0 
 
 
 
30 tablets 
indomethacin 
75mg 1 tablet 
QD to start on 
POD4 after 
completion of 
ketorolac  
 
 
 
10 tablets 
diazepam 
5mg 1-2 
tablets q8hrs 
PRN to start 
on POD0 
 
 
 
 
15 tablets 
IV ketorolac 
intraoperative 
loading dose 
 
Ketorolac 
10mg 1 tablet 
q6hrs to start 
on POD0 
 
12 tablets 
Omeprazole 
20 mg qd  
 
 
 
 
 
 
 
3 tablets 
 
 
4. ANTICIPATED RISKS  
 
A known risk to participants could be the side effects of the postoperative pain management medications and 
specifically ketorolac. Patients will be monitored post operatively and will be kept in contact with once they 
have returned home. Patients are also given the typical standard of care pain medications to ensure 
appropriate postoperative pain management. If an adverse side effect occurs, the medication will be 
discontinued, a new course of pain management will be explored for these individuals, and the patient will be 
removed from the study.  
 
Another known risk that is part of any study is a breach of confidentiality. All actions will be taken to minimize 
the risk of breach of confidentiality. More information on how patient data will be protected and stored can be 
read in the Privacy and Confidentiality section and the Data and Safety Monitoring Plan section of the 
document.  
 
There is also the risk of patients becoming uncomfortable or tired of answering the survey or pain journal 
questions. These questions were minimized to take only up to 10 minutes daily for 5 days during the post-
operative period.  
 
 
 
5. ANTICIPATED BENEFITS 

Protocol Version #1   
Date: 9/19/2023 
 
 
Participants of the study could receive adequate or improved pain management with less risk of adverse 
effects and potential abuse of narcotics if ketorolac provides similar or better pain relief to narcotics alone. 
Future patients and society could benefit from these results as addiction to opioids is a global health concern 
and an alternative could reduce the prevalence of opioid drug abuse after hip arthroscopy.  
 
 
6. RENUMERATION/COMPENSATION 
 
There is no compensation offered for taking part in this study. 
 
7. COSTS 
Ketorolac is a commonly-used and affordable postoperative pain medication, commonly covered by insurance 
and it is unlikely to incur additional cost to the patient. However, potential for increased cost will be disclosed to 
the patient in the consent process. 
 
8. ALTERNATIVES 
An alternative treatment to the one discussed in this study is to adhere to the current postoperative pain 
management protocol for hip arthroscopy set by Dr. Lynch. The patient will be provided all standard of care 
medications in addition to the study treatment if he/she chooses to drop out of the study. 
 
9. CONSENT PROCESS AND DOCUMENTATION 
 
Subjects will be screened for eligibility by a research assistant or other research personnel at a routine clinic 
appointment during which they are scheduled for a hip arthroscopy. Following consent for surgery, a member 
of the research team will approach the potential subject and asses their interest. Informed consent will be 
thoroughly reviewed with the patient.  
 
Consents will be kept in a locked area, only accessible to study personnel. This will be kept in folders so there 
is no visible identifying information. The information pulled from the EMR will be kept on a password protected 
HF computer and there will be no identifying information aside from MRN kept on these forms. All data will be 
destroyed following publication of this study or after six months of inactivity.  
  
 
10. WITHDRAWAL OF SUBJECTS 
 
Patients who opt out from the study will have their information deleted. Additionally, subjects who do not 
undergo hip arthroscopy will be excluded. Patients who do not attend their postoperative follow-up 
appointments with their surgeon and/or deviate from study protocol will also be withdrawn.  
 
11. PRIVACY AND CONFIDENTIALITY  
Confidentiality Agreements: All users of the data will sign confidentiality agreements and receive 
training on proper procedures for how to handle patient level data. 
 
System Controls to Limit Data Access: Only authorized personal will be given permission to access 
study data. 
 
Computer System Security Plan: A security plan exists within the organization to provide protection for 
patient level data. 
 
Virus Protection Software: A virus protection software is in place within the organization to protect 
patient level data. 
 
Firewall: The organization’s network system is protected by a firewall. The computer systems in place 
will have the operating system firewall in place. 

Protocol Version #1   
Date: 9/19/2023 
 
 
Computer Locking: The computer(s) have automatic locking after 20 minutes of inactivity. Computer 
System are password protected with duo activation. 
 
Physical Security: Physical access to servers and computers are restricted to only authorized 
personnel. The computer system is in a room which is inaccessible to the public.  
 
Secure Electronic Copies: All electronic copies of patient level data will be secured to a room for 
authorized personnel only. 
 
Secure Paper Copies: All paper copies of patient data will be kept under lock and key in a room 
accessible to only authorized individuals. 
 
HIPAA authorization will be obtained for all patients.  
 
 
12. DATA AND SAFETY MONITORING PLAN 
 
All electronic data will be stored on a secure, encrypted server with a second secure document 
decoding the unique patient identity number associated with this study to their medical record number.  
Patient data will be kept in a locked spreadsheet that contains no patient identification aside from a 
unique patient ID associated with their MRN. This will only be accessible to the investigators. Patients 
will be de-identified following data collection. Data will be destroyed following publication or six months 
of inactivity, whichever occurs first. All non-electronic documents will be kept in the PI's office in a 
locked drawer that only members of the research team will have access to.  
  
Unanticipated Problems and Adverse Events  
The PI or research coordinator will report any problems or adverse events to the IRB via email  
 
 
13. QUALIFICATIONS OF THE INVESTIGATOR(S) 
Briefly summarize investigators prior experience and/or history relevant to the research.  Student 
qualifications should include any relevant work, volunteer or research experience. Sometimes the 
addition of investigator qualifications makes the difference in getting approval for participant contact 
that may otherwise be too risky, for either the subjects or the student investigator.  Staff qualifications 
should be stated concisely and clearly. 
 
Dr. Thomas S. Lynch, MD Senior Staff Surgeon and Vice Chairmen of Academic Affairs in the 
Department of Orthopaedic Surgery at HFHS. Board Certified in Orthopaedic Surgery and Sports 
Medicine 
 
Dr. Michael A Gaudiani, MD PGY3 Orthopaedic Surgery Henry Ford Health System 
 
Brittaney Pratt Research Assistant, MD Candidate  
 
Neil Garg RA, 2nd year MD Candidate Wayne State University School of Medicine 
 
14. REFERENCES 
Be sure that any sources cited in the Study Aim, Background and Design section are included in your 
bibliography. Conversely, make sure that you have included references in this section that support your 
hypothesis or research purpose. 
 
1. 
Jamil M, Dandachli W, Noordin S, Witt J. Hip arthroscopy: Indications, outcomes and 
complications. International Journal of Surgery. 2018;54:341-344. doi:10.1016/j.ijsu.2017.08.557 

Protocol Version #1   
Date: 9/19/2023 
 
2. 
Beck EC, Nwachukwu BU, Jan K, et al. The Effect of Postoperative Opioid Prescription Refills on 
Achieving Meaningful Clinical Outcomes After Hip Arthroscopy for Femoroacetabular Impingement 
Syndrome. Arthroscopy - Journal of Arthroscopic and Related Surgery. 2020;36(6):1599-1607. 
doi:10.1016/j.arthro.2020.02.007 
3. 
Kahlenberg CA, Patel RM, Knesek M, Tjong VK, Sonn K, Terry MA. Efficacy of Celecoxib for Early 
Postoperative Pain Management in Hip Arthroscopy: A Prospective Randomized Placebo-Controlled 
Study. Arthroscopy - Journal of Arthroscopic and Related Surgery. 2017;33(6):1180-1185. 
doi:10.1016/j.arthro.2017.01.016 
4. 
LaPorte C, Rahl MD, Ayeni OR, Menge TJ. Postoperative Pain Management Strategies in Hip 
Arthroscopy. Curr Rev Musculoskelet Med. 2019;12(4):479-485. doi:10.1007/s12178-019-09579-x 
5. 
Jildeh TR, Abbas MJ, Hasan L, Moutzouros V, Okoroha KR. Multimodal Nonopioid Pain Protocol Provides 
Better or Equivalent Pain Control Compared to Opioid Analgesia Following Arthroscopic Rotator Cuff 
Surgery: A Prospective Randomized Controlled Trial. Arthroscopy - Journal of Arthroscopic and Related 
Surgery. 2022;38(4):1077-1085. doi:10.1016/j.arthro.2021.11.028 
6. 
Moutzouros V, Jildeh TR, Tramer JS, et al. Can We Eliminate Opioids After Anterior Cruciate Ligament 
Reconstruction? A Prospective, Randomized Controlled Trial. American Journal of Sports Medicine. 
2021;49(14):3794-3801. doi:10.1177/03635465211045394 
7. 
Bloom DA, Kirby DJ, Thompson K, Baron SL, Chee C, Youm T. Effect of Acetaminophen on Postoperative 
Percocet Use In Hip Arthroscopy: A Randomized Controlled Trial. Arthroscopy - Journal of Arthroscopic 
and Related Surgery. 2021;37(2):530-536. doi:10.1016/j.arthro.2020.09.046