Hip Arthroscopy Postoperative Opioid Demands

NCT04094701 | Recruiting

• 1 other identifier: 19071807
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (7)

• Pain Score

  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.

  1 month postoperatively

• Pain Score

  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.

  3 months postoperatively

• Pain Score

  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.

  6 months postoperatively

• Pain Score

  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.

  12 months postoperatively

• Total morphine equivalents taken

  Standardized reporting of amount of opioids taken

  In the first 30 days after discharge

• Number of unused opioid pills

  Pills not taken by patient

  In the first 30 days after discharge

• Opioid disposal rates

  Number of unused pills properly disposed of

  In the first 30 days after discharge

Secondary Outcomes (16)

• Hip disability and osteoarthritis outcome score

  1 month postoperatively

• Hip disability and osteoarthritis outcome score

  3 months postoperatively

• Hip disability and osteoarthritis outcome score

  6 months postoperatively

• Hip disability and osteoarthritis outcome score

  12 months postoperatively

• Harris Hip score

  1 month postoperatively

Study Arms (2)

Control Group

PLACEBO COMPARATOR

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).

Other: Control Group Regimen

Experimental Group - Opioid Reduced

EXPERIMENTAL

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).

Other: Opioid reduced regimen

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.

Control Group

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

Experimental Group - Opioid Reduced

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Pain; Femoracetabular Impingement; Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Central Study Contacts

Carla M. Edwards

CONTACT

312-563-5735; carla_edwards@rush.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Investigators propose two standardized prescribing patterns across all teams. The first would be the control postoperative prescribing pattern and the second would be the experimental opioid reduced prescribing pattern. Patients will not be informed if their postoperative prescriptions are part of the control or opioid reduced prescribing pattern. Of note, patients will be allowed to cross over from the opioid reduced experimental group to the standard of care control group if they have breakthrough pain following surgery.

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 19, 2019
• Study Start: October 21, 2020
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

US (1)