Hip Arthroscopy Postoperative Opioid Demands

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rush University Medical Center
Study ID
NCT04094701
Status
Recruiting
Apply to this trial

Conditions

  • Femoral Acetabular Impingement
  • Labral Tear, Glenoid
  • Opioid Use
  • Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Control Group Regimen — OTHER
    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 — OTHER
    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

Study Details

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.

Key Dates

Start date
Oct 21, 2020
Status verified
Aug 2025
Primary completion
Nov 30, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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).

Primary Outcome Measure

Pain Score [ Time Frame: 1 month postoperatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60612
Carla M Edwards, PhD
[email protected]
312-563-5735
Jorge Chahla, MD, PhD (PRINCIPAL_INVESTIGATOR)
Shane Nho, MD (SUB_INVESTIGATOR)

Find similar trials in Chicago, IL

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
Rush University Medical Center· Chicago, IL

Related Studies