NCT04094701 · Rush University Medical Center
Hip Arthroscopy Postoperative Opioid Demands
What this study is about
This study will be a forward-looking, single-blinded, randomly assigned controlled trial (RCT), investigating the influence of the number of opioid pills prescribed following primary hip arthroscopy. All patients who sign the consent form will be enrolled in the suited and randomly assigned to one of the two treatment treatment group$1.
View original scientific description
This study will be a prospective, single-blinded, randomized controlled trial (RCT), investigating the influence of the number of opioid pills prescribed following primary hip arthroscopy. All patients who sign the consent form will be enrolled in the suited and randomized to one of the two treatment arms. The intervention group will receive 5 Norco pills, gabapentin (30 mg, once daily for 10 days following surgery), and Tylenol (1000 mg, three times daily for 10 days following surgery) while the control will receive the standard at our practice of 30 Norco pills.
Interventions
OTHER
Control Group Regimen
Norco (hydrocodone-acetaminophen) 5mg-325mg, 30 total pills. This is the standard of care prescribing procedure for pain management after hip arthroscopy.
OTHER
Opioid reduced regimen
Tylenol extra strength (1000 mg, three times daily for 10 days following surgery), Gabapentin (300 mg at night for 10 days following surgery) and Norco (hydrocodone-acetaminophen) 5mg-325mg, 5 total pills
Primary outcome measures
Pain Score
Time frame: 1 month postoperatively
Visual Analog Scale: unidimensional measure of pain intensity, which has been widely used in diverse adult populations. Score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Pain Score
Time frame: 3 months postoperatively
Visual Analog Scale: unidimensional measure of pain intensity, which has been widely used in diverse adult populations. Score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Pain Score
Time frame: 6 months postoperatively
Visual Analog Scale: unidimensional measure of pain intensity, which has been widely used in diverse adult populations. Score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Pain Score
Time frame: 12 months postoperatively
Visual Analog Scale: unidimensional measure of pain intensity, which has been widely used in diverse adult populations. Score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Total morphine equivalents taken
Time frame: In the first 30 days after discharge
Standardized reporting of amount of opioids taken
Number of unused opioid pills
Time frame: In the first 30 days after discharge
Pills not taken by patient
Opioid disposal rates
Time frame: In the first 30 days after discharge
Number of unused pills properly disposed of
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adult patients age 18-80 years
- English speaking
- Opioid naive patient (defined as not taking opioid pills within 6 weeks prior to surgery), confirmed by checking the Illinois Prescription monitoring program
- Primary hip arthroscopy
- Written and informed consent for study participation
Exclusion criteria
- Minors (\<18 years of age)
- Opioid tolerant patients
- Revision surgery
- Prior infections of the operative joint
- History of active malignancy within the past 5 years
- Chronic pain conditions including low back pain, chronic pain syndrome, fibromyalgia
- History of alcohol or other substance use disorder
- Other disease states including rheumatologic conditions, diabetes mellitus, hypo/hyperthyroidism, depression, anxiety
- Grade IV chondral defects
Where
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 13, 2026 · Source of record for eligibility and locations