Hip Arthroscopy Postoperative Opioid Demands

NCT ID: NCT04094701

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-21
• Study Completion Date: 2027-03-31

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.

Detailed Description

Follow-up will take place at 1, 3, 6, and 12 months postoperatively. Variables of interest will include postoperative patient pain scores (i.e. Visual Analog Scale or VAS), total morphine equivalents taken in the first 30 days after discharge, number of unused opioid pills, opioid disposal rates, and standard patient reported outcomes measures (PROMs) including hip disability and osteoarthritis outcome score (HOOS), Harris Hip score (HHS), VAS for pain, international hip outcome tool (iHOT-12), and Hip outcome score (HOS).

For the purpose of this study, the 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.

Timeline of Events:

1. Following informed consent during the office visit when surgery is scheduled, all patients will be randomized to one of the postoperative pain management protocols, either the control or opioid reduced.

2. Subjects will proceed with hip arthroscopy, including appropriate treatment and documentation of concomitant injuries.

3. Over the course of the 1st month postoperatively, patients will complete a 30-day diary detailing which medications they took on each day and their daily average pain level (indicating whether physical therapy was performed). Data pertaining to prescription refills (I.e., number of refills, time to refill), number of left over pain medications, and disposal rates of opioid medications will also be recorded at these time points as well.

4. Patients will return for standard of care postoperative visits at 1, 3, 6, and 12 months postoperatively. Patients will be asked to complete PROM questionnaires at the 3, 6, and 12 month follow-up time points

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: PLACEBO_COMPARATOR

Control Group Regimen

Intervention Type: OTHER

Norco (hydrocodone-acetaminophen) 5mg-325mg, 30 total pills. This is the standard of care prescribing procedure for pain management after hip arthroscopy.

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).

Group Type: EXPERIMENTAL

Opioid reduced regimen

Intervention Type: 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

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.

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rush University Medical Center

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Carla M. Edwards

Role: CONTACT

carla_edwards@rush.edu

312-563-5735

Facility Contacts

Carla M Edwards, PhD

Role: primary

carla_edwards@rush.edu

312-563-5735

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

19071807

Identifier Type: -

Identifier Source: org_study_id