Recruiting
Phase 3

Opioid-Limited Regimen

Sponsor:

Emory University

Code:

NCT07348627

Conditions

Pain Management

Opioid Consumption

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Placebo

Oxycodone 5 mg

Multimodal Non-Opioid Analgesia

Study Details

Brief summary:

The goal of this clinical trial is to evaluate whether an opioid-sparing postoperative pain regimen can reduce opioid consumption and maintain effective pain control in adults undergoing anterior total hip arthroplasty for osteoarthritis.

The main questions it aims to answer are:

  • Does an opioid-limited regimen result in lower postoperative opioid use compared with a standard opioid prescription?
  • Does the opioid-limited regimen provide comparable or improved postoperative pain control and patient satisfaction?

Conditions

Pain Management

Opioid Consumption

Study ID

NCT07348627

Start date

Mar 19, 2026

Status verified date

Apr, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of hip osteoarthritis requiring primary arthroplasty
  • Scheduled to undergo anterior total hip arthroplasty (THA)
  • Able to comply with study procedures and follow-up visits
  • Able to provide informed consent

Exclusion Criteria:

  • Concurrent significant injuries to other bones or organs
  • Local infection at or near the surgical site
  • Preoperative opioid use within 4 weeks prior to surgery
  • History of severe heart disease (NYHA Class II or higher), renal failure, or liver dysfunction
  • Chronic liver disease
  • Neurological or psychiatric conditions that may influence pain perception
  • Pregnancy
  • History of alcohol or medication abuse
  • Inability to take NSAIDs
  • Use of postoperative DVT prophylaxis other than aspirin 81 mg twice daily
  • Diabetes mellitus with HbA1c > 8.0%
  • Diagnosis of chronic pain syndrome or fibromyalgia
  • Pain Catastrophizing Scale (PCS) score > 29
  • Any condition that, in the investigator's judgment, may interfere with adherence to study procedures or follow-up

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Opioid-Sparing Regimen

Participants receive a standardized multimodal non-opioid analgesic regimen throughout the perioperative period and are discharged with placebo tablets instead of a standard opioid prescription. All participants receive counseling from a Life Care Specialist and a limited supply of rescue hydromorphone for severe breakthrough pain.

active comparator: Standard Opioid Prescription

Participants receive the same standardized multimodal non-opioid analgesic regimen and Life Care Specialist counseling as the experimental group, but are discharged with a standard opioid prescription.

Interventions

Placebo

  • 28 tablets identical in appearance to 5-mg oxycodone
  • Taken 1-2 tablets every 4 hours as needed for moderate to severe pain
  • Dispensed by Investigational Drug Services
  • Used in combination with standardized multimodal analgesia

Oxycodone 5 mg

  • 28 tablets of 5-mg oxycodone
  • Taken 1-2 tablets every 4 hours as needed for moderate to severe pain
  • Represents standard postoperative prescribing practi

Multimodal Non-Opioid Analgesia

Multimodal Non-Opioid Analgesia (Standardized Regimen)

Includes:

  • Acetaminophen
  • Meloxicam
  • Methylprednisolone taper
  • Spinal anesthesia
  • Periarticular local anesthetic injection
  • Postoperative scheduled acetaminophen and NSAIDs
  • Counseling by Life Care Specialist
  • Two 2-mg hydromorphone tablets for rescue only

Primary outcome measure

  • Daily Pain Scores (Numeric Rating Scale, NRS) [ Time Frame: Postoperative Days 1-7 ]
  • Opioid Consumption (Morphine Milligram Equivalents, MME) [ Time Frame: 1 week, 3 weeks, and 3 months postoperatively ]
  • Pain-Related Contacts to Clinical Team [ Time Frame: Up to 3 months postoperatively ]
  • Medication-Related Side Effects [ Time Frame: Postoperative Days 1-7 ]
  • Opioid Prescription Refills [ Time Frame: Up to 3 months postoperatively ]
  • Patient Satisfaction With Pain Control [ Time Frame: 1 week, 3 weeks, and 3 months ]

Central Contacts and Locations

Central contacts

Ajay Premkumar, MD

404-778-3350ajay.premkumar@emory.edu

Darrell Favors

darrell.favors@emory.edu

Locations

Emory University Orthopedics and Spine Hospital

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Ajay Premkumar, MD

404-778-3350ajay.premkumar@emory.edu

More Information

Sponsor

Emory University

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Keywords

  • Total hip arthroplasty
  • Numeric Rating Scale for pain
  • Visual Analog Scale for nausea
  • Life Care specialist

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-04-17.