How Many Opiates Should be Prescribed for Pain in Patients Undergoing Hip Arthroscopy?
Phase: NA
Conditions: Hip Injuries
Sponsor: Northwestern University

 
Hip Arthroscopy RCT study 
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Official title: How Many Opiates Should be Prescribed for Pain in Patients 
Undergoing Hip Arthroscopy?  
NCT number: NCT04169113 
Document date: 03Jun2019 
 

 
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PROTOCOL TITLE: 
How many opiates should we prescribe for pain in patients undergoing hip arthroscopy? 
 
PRINCIPAL INVESTIGATOR: 
Vehniah Tjong, MD Northwestern University 
Department of Orthopaedic Surgery 676 N. St. Clair, Suite 1350 
Chicago, IL 60611  
Vehniah.tjong@northwestern.edu 
 
VERSION NUMBER: 
2.0 
 
VERSION DATE: 
6/3/2019 
 
STUDY SUMMARY: 
 
Investigational Agent(s)  
(Drugs or Devices) 
N/A 
IND / IDE / HDE #  N/A 
Indicate 
Special Population(s) 
Children  
 Children who are wards of the state  
 Adults Unable to Consent   
 Cognitively Impaired Adults  
 Neonates of Uncertain Viability  
 Pregnant Women  
 Prisoners (or other detained/paroled individuals)  
 Students/Employees  
Sample Size 120, 60 in each arm 
Funding Source Department of Orthopaedic Surgery 
Indicate the type of consent 
to be obtained 
Written  
Verbal/Waiver of Documentation of Informed Consent 
Waiver of HIPAA Authorization  
Waiver/Alteration of Consent Process   
Site 
 Lead Site ( For A Multiple Site Research Study) 
 Data Coordinating Center (DCC) 
Research Related Radiation 
Exposure 
Yes  
 No  
DSMB / DMC / IDMC 
Yes  
No 
 
 

 
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OBJECTIVES 
 
The purpose of the study is to determine if opiates are required to achieve adequate 
analgesia after hip arthroscopy in outpatient surgery. 
 
We hypothesize that patients are frequently prescribed more opiates than are needed 
after surgery, resulting in excess medications that are at risk for misuse, diversion and 
contribution to the opioid epidemic. 
 
BACKGROUND 
Perioperative pain management is an important aspect of quality patient care. Opioid pain 
medications are increasingly being used for pain control, with the United States writing over 
250 million prescriptions for painkillers per year[1]. Increased usage has led to unintended 
negative consequences for individuals and society. It is estimated that 46 people die each day 
from an overdose of prescription painkillers, and individual use can lead to the development of 
tolerance and worse treatment outcomes [1, 2]. Further issues arise when opioids are misused, 
it is estimated that nontherapeutic use has increased three fold in recent years[3]. In the United 
States alone in 2006 the estimated total cost of opioid prescription misuse was $53.4 billion, of 
which $42 billion was attributed to lost productivity, $8.2 billion to criminal justice cost and the 
remainder drug abuse treatment and medical complications[4]. The federal government has 
recognized this epidemic and raised a call for clinicians to more responsibly prescribe opiate 
pain medications[5]. 
 
Opiate use has increased in recent years, from 2000-2010 the use of opiates in office based 
visits nearly doubled from 11.3% to 19.6% whereas there was no change in the prescribing of 
non-opioid pharmacotherapies. Further, when specifically looking at new musculoskeletal pain 
visits, one half resulted in pharmacologic treatment, with the prescribing of non-opioid 
pharmacotherapies decreasing from 38% to 29% from 2000 to 2010, respectively[6]. The 
clinical use of opioids for post-operative pain control has also been linked to the opioid 
epidemic and risk of future abuse[7]. Legitimate opioid use before high school graduation is 
independently associated with a 33% increased risk of future misuse after high school[8]. 
 
It has been estimated that orthopedic surgeons prescribe 7.7% of all opioids in the United 
States[9].Special attention needs to be paid to the amount of opioid pain medications 
orthopedic surgeons prescribe to patients after ambulatory surgery, there is considerable 
variability among surgeon and procedure in regards to the amount of opioids to prescribe with 
many patients left with excess unused medication[10].An analysis of 250 patients undergoing 
outpatient upper extremity surgery found that on average patients consumed 10 opioid pills, 
with 19 pills left over and a total of 4,639 pills going unused in the cohort[10]. Leftover 
prescription opioids are at risk for diversion to family and friends for nonmedical use[11]. 
Further studies are needed to quantify the amount of opioids to prescribe for specific 
orthopedic procedures to limit excess narcotic use, misuse, diversion and contribution to the 
opioid epidemic. 
 
STUDY ENDPOINTS: 
This study is observational in nature. The study will end once we have collected data for 60 
patients for each arm. 
 
STUDY INTERVENTION(S)/INVESTIGATIONAL AGENT(S): 
N/A 
 
PROCEDURES INVOLVED: 
This study will be a pilot randomized control trial to establish non-inferiority in opiate prescribing 
patterns. 
 
Eligible patients will be identified in clinic by the treating attending physician. Patients will 
subsequently be approached by research personnel at that time. In the event that a patient 

 
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determines that they wish to pursue surgery and this is discussed by phone without an 
additional clinic visit they will be approached on the day of surgery by our research staff. 
 
All patients will fill out a preoperative questionnaire asking them the questions below related to 
specific risk factors for opiate use/abuse in addition to the iHOT-12, the NPRS, and the PCS. 
 
 
Age 
 
Sex 
 
BMI 
 
Do you actively smoke cigarettes? 
 
If no, have you ever consistently smoked cigarettes (daily for > 1 month)? 
 
What is your employment status? 
 
Is this injury part of a workers’ compensation claim? 
 
Are you actively participating in organized sporting activities? If so, at what level (ie 
professional, college, recreational) 
 
Are you currently using narcotic pain medications? 
 
Do you have a personal hx of substance abuse (ex. prescription or illicit drugs, 
alcohol)? 
 
Do you have a family history of substance abuse (ex. prescription or illicit drugs, 
alcohol)? 
 
What is the highest level of education you attained? 
 
What is your average yearly household income? 
 
The patients undergoing hip arthroscopy will be randomized into two groups prior to surgery by 
the research staff. The surgeons’ physician assistants will be responsible for prescribing the 
appropriate medications. 
 
 
Group 1: Will be prescribed 60 opiate tablets in addition to other routine post- operative 
pain medication regimens. 
 
Group 2: Will be prescribed 30 opiate tablets in addition to other routine post- operative 
pain medication regimens. 
 
In order to limit potential variability in sample size, block randomization will be utilized with the 
following parameters: 12 blocks with 5 patients in each block. The blocks will be as follows: 
 
Block 1/7/13 
22112 
 
Block 2/8/14 
11221 
 
Block 3/9/15 
21121 
 
Block 4/10/16 
21122 
 
Block 5/11/17 
21211 
 
Block 6/12/18 
22121 
 
A computer program will randomly select a block number. Once a block is selected patients will 

 
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be enrolled in the order listed in the block. For example, if block 6 is selected initially Patient 1 
will be enrolled in Group 2, Patient 2 will be enrolled in group 2, Patient 3 will be enrolled in 
group 1, etc. After every 5th patient is randomized to a group a new block will be randomly 
selected. 
 
The surgeons’ physician assistants will be responsible for prescribing the appropriate 
medications. To clarify, we do not electronically prescribe C2 medications as a routine part of 
practice and do not intend to as part of the study. 
 
All patients will be provided the same counseling regardless of the amount of narcotics they are 
prescribed. In the event that a patient requires additional narcotics on top of the original 
prescription the treating surgeon will need to be notified in order to accurately assess the 
amount already consumed and appropriately prescribe additional medications. 
 
Please note that there is considerable variability in opiate prescribing between practitioners. 
Patient's that undergo hip arthroscopy typically are prescribed between 30- 60 Norco 
depending on the practitioner. Our randomization falls within the variability of the current 
standard for which there is no evidence based literature. Additionally, we are attempting to 
discern if 30 opiate tablets would be sufficient for patients undergoing hip arthroscopy. We 
suspect that the majority of patients prescribed 60 tablets do not take greater than 50% of what 
they are prescribed. We are interested in determining the number of opiates left over after hip 
arthroscopy and if the amount prescribed affects the total amount consumed. 
 
Following their operation, all patients will have Pain -Numeric Pain Rating Scale (NPRS) 
assessed at 2 hours post-surgery by the authorized co-investigators or research staff while the 
patient is recovering in the post-anesthesia care unit (PACU). 
 
Additionally, a phone call will be placed at 24 hours, 48 hours and between 7-14 days after 
surgery and asked a Numeric Pain Rating Score (NPRS), how many opiate pain medications 
they took, how many are left over and when the date they stopped taking them. 
 
NPRS scores can be performed verbally. The following statement will be provided to patients: 
 
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. “no pain”) to 
'10' representing the other pain extreme (e.g. “pain as bad as you can imagine” or “worst pain 
imaginable”), please rate your pain on a scale of 0-10. 
 
If they are still taking pain medications at that point, an additional follow-up call will be placed at 
21 days (+1-3 days) after surgery asking the same questions. We will allow 4 total phone calls 
(24 hours, 48 hours, 7-14 days, and 21 (+ 1 to 3) days post-surgery. If patients continue to take 
narcotics 21 days after surgery they will be listed as >3 weeks of narcotic use) 
 
Refill requests will also be recorded. 
Maximum total length of the study will be 21 days post-surgery. 
 
Pre-Operative - All Patients 
 
Pre-operative Questionnaire 
 
iHOT-12 
 
Numeric Pain Rating Scale (NPRS) 
 
Pain Catastrophizing Scale (PCS) 
Randomization – Two Groups 

 
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Group 1, n=60 
Group 2, n=60 
Post-Operative Medication Regimen: 
-Hydrocodone/acetaminophen 10- 
325mg 1-2 tabs q 6 hrs PRN (60 tablets) 
-Naprosyn 500mg BID for 4 weeks (60 
tablets) 
-Aspirin 325mg BID for 4 weeks (60 
tablets) 
Post-Operative Medication Regimen: 
-Hydrocodone/acetaminophen 10- 
325mg 1-2 tabs q 6 hrs PRN (30 tablets) 
-Naprosyn 500mg BID for 4 weeks (60 
tablets) 
-Aspirin 325mg BID for 4 weeks (60 
tablets) 
Postoperative Follow-Up – All Patients 
2 hours – NPRS Pain Scores 
24 hours – NPRS Pain Scores, Opiate Count, Side Effects, Still Taking?, Refill 
Requests 
48 hours – NPRS Pain Scores, Opiate Count, Side Effects, Still Taking?, Refill 
Requests 
7 -14 days – NPRS Pain Scores, Opiate Count, Side Effects, Still Taking?, Refill 
Requests 
 
The following data will also be retrieved from each study subject’s EMR: 
 
• 
Preoperative medications 
• 
Date, Side, duration of surgery and procedures performed 
• 
Medications prescribed upon discharge from the surgery center 
• 
X-rays 
• 
Perioperative data (pain scores before and after surgery, drugs given, anesthesia 
blocks) 
 
DATA AND SPECIMEN BANKING 
Identifiable data will be collected and transcribed into NU SharePoint in Excel format. All survey 
data will be collected through REDCap. There will only be one copy of the coded identifier 
Excel datasheet, which will be password protected and stored on NU SharePoint as well on our 
department shared drive. Access to both these databases will only be available to members of 
Dr. Tjong’s research team. Identifying information will be kept separately. Subjects’ privacy 
interest will be maintained as they will only interact with or provide sensitive information to 
members of Dr. Tjong’s research team after they have confirmed interest in enrolling in the 
study. 
 
Research data will be stored electronically, password-protected, and encrypted on NU 
SharePoint and REDCap. Only members of the research team will have access to the data. 
Recorded data will be retained for a period of 5 years following completion of the study’s 
primary endpoint(s) per NU policy regarding compliant retention of data for Human Subject 
research. The recorded data will thereafter be permanently deleted. 
 
SHARING RESULTS WITH PARTICIPANTS 
N/A 
 
STUDY TIMELINES 
This study will be observational in nature. Patients will fill out a preoperative questionnaire 
related to specific risk factors for opiate use/abuse. Additionally, they will fill out several patient 
reported outcome instruments including the International Hip Outcome Tool (iHOT-12, hip 
functional measure), Numeric Pain Rating Scale (NPRS), and Pain Catastrophizing Scale 
(PCS) prior to surgery. Following their operation a phone call will be placed at 24 hours, 48 
hours and between 7-14 days after surgery and asked how many opiate pain medications they 

 
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took, how many are left over and when the date they stopped taking them. Additionally, an 
NPRS value will be obtained at those phone calls. If they are still taking pain medications at 
that point 1 follow-up call will be placed at 21 days again asking the same questions. Maximum 
total length of the study will be 21 days post-surgery. 
 
INCLUSION AND EXCLUSION CRITERIA 
Inclusion Criteria: 
 
All patients presenting to Northwestern Memorial Hospital (NMH) or to a Northwestern 
orthopaedic surgery faculty member’s clinic undergoing hip arthroscopy 
 
18 years old or greater 
 
Ability to read and speak English 
Exclusion Criteria: 
 
Revision surgery 
 
Oncologic surgery 
 
Arthroscopic hip surgery that involves procedures other than labral repair, 
acetabuloplasty, CAM plasty, IT band windowing, Iliopsoas lengthening 
 
Adults unable to consent 
o Individuals who are not yet adults (infants, children, teenagers) 
o Pregnant women 
o Prisoners 
o Patients currently taking narcotics, chronic pain management patients, 
history of substance abuse 
VULNERABLE POPULATIONS 
N/A 
 
RECRUITMENT METHODS 
Eligible patients will be identified in clinic by the treating attending physician. Patients will 
subsequently be approached by research personnel at that time. In the event that a patient 
determines that they wish to pursue surgery and this is discussed by phone without an 
additional clinic visit they will be approached on the day of surgery by our research staff. 
 
Each patient will be provided with a paper copy of the consent form at their pre- operative 
assessment to review and sign for their participation in the study. 
 
COMPENSATION FOR PARTICIPATION IN RESEARCH ACTIVITIES 
N/A 
 
WITHDRAWAL OF PARTICIPANTS 
N/A 
 
RISKS TO PARTICIPANTS 
No identifiable physical risks to the patient are foreseen. Some of the preoperative 
questionnaire questions may be upsetting to patients. Specifically questions about personal or 
family history of substance abuse. 
 
There are no procedures included in this study that have risks that are currently unknown. Our 
planned opiate prescription amounts fall within the normal variability of current practice at 
Northwestern. 
 
There are no risks to others who are not subjects of the study. 
 
POTENTIAL BENEFITS TO PARTICIPANTS 
The participants are not likely to receive any benefit from the proposed research; however, 
future patients and society at large will benefit from the knowledge gained. 
 

 
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DATA MANAGEMENT AND CONFIDENTIALITY 
The above data will be collected for each patient. Mean opiate use and left over opiates will be 
reported. Demographic data will be recorded, linear regression will be performed to determine 
risk for prolonged opiate us. Study is observational with reporting of means as the main outcome 
measure, no power analysis is necessary. 
 
Each member of Dr. Tjong’s research team has been CITI certified for human subjects’ 
research. Only members of Dr. Tjong’s research team will have access to study data, which will 
be encrypted on a secure server with separations of identifiers and subject data. 
 
Research data will be stored electronically, password-protected, and encrypted on a 
Northwestern Medicine secure server. Only members of the research team will have access to 
the data. Recorded data will be deleted at study completion and transcripts stored in a locked 
file drawer at Northwestern Memorial Hospital for future studies. 
 
PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF PARTICIPANTS 
N/A 
 
PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF PARTICIPANTS 
Confidentiality of patient information will be maintained using a secure, password-protected 
web portal (REDCap) and database. This database will be de-identified. Access to this 
database will only be available to members of Dr. Tjong’s research team. Identifying 
information will be kept separately in a password-protected desktop database or locked-file 
drawer. Subjects’ privacy interest will be maintained as they will only interact with or provide 
sensitive information to members of Dr. Tjong’s research team after they have confirmed 
interest in enrolling in the study. 
 
Efforts will be made to make subjects feel at ease with the research by explaining risks and 
benefits of participation in the study. A member of Dr. Tjong’s research team will explain the 
preoperative questionnaire and the post-operative phone calls. 
 
Dr. Tjong’s team only has permission to access the subjects’ medical records for research 
purposes after they have provided informed consent to enroll in the study. 
 
COMPENSATION FOR RESEARCH-RELATED INJURY 
N/A 
 
ECONOMIC BURDEN TO PARTICIPANTS 
There may be the possibility that there will be a greater expense to subjects who are in HIP-
Group 1 as they will be required to pay for two times the number of pain pills. 
 
However, for patient's paying cash, the cost for 30 and 60 Norco at the Northwestern 
Walgreens are $31.49 and $56.99 respectively. This discrepancy will likely be less for those 
with prescription insurance. Some patients are prescribed 60 Norco as standard of practice so 
those being prescribed 30 are incurring less of an expense. This could potentially be somewhat 
of a benefit of the study. 
 
CONSENT PROCESS 
Each subject enrolled in the study will provide informed consent for participation in the study. 
 
Informed consent will initially take place during initial contact with potential subjects in the 
orthopedic surgery clinic. Risks, benefits, and alternatives of participation in the study as well 
as the ability to withdraw participation at any time will be discussed with the eligible subject. 
Understanding of these aspects of the study as well as whether the potential subject would like 
to enroll in the study will be confirmed over the phone. 
 

 
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WAIVER OR ALTERATION OF CONSENT PROCESS 
N/A 
 
PROTECTED HEALTH INFORMATION (PHI AND HIPAA) NON-ENGLISH SPEAKING 
PARTICIPANTS 
Non-English speaking participants will not be included in the study. 
 
QUALIFICATIONS TO CONDUCT RESEARCH AND RESOURCES AVAILABLE 
The faculty and co-investigators for this study are board certified orthopedic surgeons and 
foremost experts in their respective fields. Drs. Tjong and Terry combined perform 
approximately 300 hip arthroscopy procedures per year. We anticipate at least 80% will enroll 
in the study and data will be able to be collected within 3 months. 
 
STUDY-WIDE RECRUITMENT METHODS 
N/A