Recruiting

Observational Study

Sponsor:

Rush University Medical Center

Code:

NCT04094701

Conditions

Opioid Use

Pain

Femoral Acetabular Impingement

Labral Tear, Glenoid

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Control Group Regimen

Opioid reduced regimen

Study Details

Brief summary:

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.

Conditions

Opioid Use

Pain

Femoral Acetabular Impingement

Labral Tear, Glenoid

Study ID

NCT04094701

Start date

Oct 21, 2020

Status verified date

Aug, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

170 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Control Group

Control Group will receive the following pain medication regimen:

\- Norco (hydrocodone-acetaminophen) 5mg-325mg, 30 total pills

The following non-opioid medications are standard of care at our practice following hip arthroscopy and, thus, will be prescribed to patients regardless of the group they are randomized to: aspirin (325 mg, two times daily for 30 days) and Indocin (75 mg extended release, one time daily for 10 days).

experimental: Experimental Group - Opioid Reduced

Experimental - opioid reduced: 50% less oxycodone relative to control group

  • Tylenol extra strength (1000 mg, three times daily for 10 days following surgery)
  • Gabapentin (300 mg at night for 10 days following surgery)
  • Norco (hydrocodone-acetaminophen) 5mg-325mg, 5 total pills

The following non-opioid medications are standard of care at our practice following hip arthroscopy and, thus, will be prescribed to patients regardless of the group they are randomized to: aspirin (325 mg, two times daily for 30 days) and Indocin (75 mg extended release, one time daily for 10 days).

Interventions

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.

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 measure

  • Pain Score [ Time Frame: 1 month postoperatively ]
  • Pain Score [ Time Frame: 3 months postoperatively ]
  • Pain Score [ Time Frame: 6 months postoperatively ]
  • Pain Score [ Time Frame: 12 months postoperatively ]
  • Total morphine equivalents taken [ Time Frame: In the first 30 days after discharge ]
  • Number of unused opioid pills [ Time Frame: In the first 30 days after discharge ]
  • Opioid disposal rates [ Time Frame: In the first 30 days after discharge ]

Central Contacts and Locations

Central contacts

Carla M. Edwards

312-563-5735carla_edwards@rush.edu

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Carla M Edwards, PhD

312-563-5735carla_edwards@rush.edu

Principal Investigator:

Jorge Chahla, MD, PhD

More Information

Sponsor

Rush University Medical Center

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2026-08-13.