Recruiting

Opioid Management

Sponsor:

Henry Ford Health System

Code:

NCT07672808

Conditions

Arthroplasty, Replacement, Hip

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard Multimodal Analgesic Regimen with Opioid Prescription

Opioid-Reduced Multimodal Analgesic Regimen with Printed Prescription

Study Details

Brief summary:

This study examines whether patients undergoing total hip replacement surgery can manage their pain effectively while using fewer opioid pain medications. Participants will be randomly assigned to one of two groups. The first group will receive the standard postoperative pain medication regimen, with all prescriptions sent directly to their pharmacy as usual. The second group will receive the same medications, but their opioid prescription will only be provided as a printed copy rather than being sent directly to the pharmacy, requiring them to choose whether to fill it. All participants will keep a pain journal and complete questionnaires about their medication intake over the first 21 days post-op as well as there function and wellbeing at follow up visits over 3 months. The goal is to determine whether this approach reduces opioid use while still adequately controlling pain after hip replacement surgery.

Conditions

Arthroplasty, Replacement, Hip

Study ID

NCT07672808

Start date

Jul 20, 2026

Status verified date

Jun, 2026

Completion date

May 30, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult patients age 18 and older
  • Patients who have undergone total hip arthroplasty by a single, fellowship trained Orthopaedic Surgeon.

Exclusion Criteria:

  • Patients with incomplete data in medical records
  • Chronic opioid use in the last 3 months
  • Ipsilateral joint surgery in the last year
  • Cannot tolerate oral medications
  • Swallowing difficulties
  • Intolerance to Tylenol, Celebrex, Robaxin, Neurontin, or Tramadol
  • History of Alcohol abuse
  • History of Drug abuse
  • History of Renal impairment
  • History of Peptic ulcer disease
  • History of GI bleeding
  • Illicit narcotic usage in past 6 months
  • Chronic liver disease
  • Chronic pain syndrome

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard Postoperative Pain Protocol (Control)

Participants receive the standard postoperative multimodal pain regimen following primary total hip arthroplasty. All prescriptions, including opioids, are sent directly to the patient's pharmacy per usual care. Participants complete a postoperative pain journal, medication log, respond to phone/text check-ins regarding pain scores, and complete PROMIS, HOOS Jr., and Harris Hip Score questionnaires at follow-up visits postoperatively.

experimental: Opioid-Reduced Postoperative Pain Protocol (Treatment)

Participants receive the standard postoperative multimodal pain regimen following primary total hip arthroplasty. Opioid prescriptions (Tramadol) are printed and given to the patient rather than sent directly to the pharmacy, requiring the patient to drive to the pharmacy if they choose to fill them. Participants complete a postoperative pain journal, mediation logs, respond to phone/text check-ins, and complete PROMIS, HOOS Jr., and Harris Hip Score questionnaires at follow-up visits postoperatively.

Interventions

Standard Multimodal Analgesic Regimen with Opioid Prescription

Participants receive the standard postoperative multimodal pain regimen following primary total hip arthroplasty. All prescriptions are sent directly to the patient's pharmacy. Opioid consumption tracked via the Michigan Automated Prescription System (MAPS) and patient medication journal. Pain and medication consumption are assessed via daily pain/medication logs daily for the first week, then weekly for two additional weeks.

Opioid-Reduced Multimodal Analgesic Regimen with Printed Prescription

Participants receive the standard postoperative multimodal pain regimen following primary total hip arthroplasty. Tramadol is prescribed but the prescription is printed and given to the patient rather than sent to the pharmacy, requiring the patient to actively choose to fill it. This behavioral barrier is designed to reduce opioid consumption while preserving patient autonomy. Pain and medication intake is assessed via daily pain journals and medication logs for the first week, then weekly for two additional weeks. Opioid consumption is also tracked via the Michigan Automated Prescription System (MAPS).

Primary outcome measure

  • Postoperative Pain Score (Visual Analog Scale) [ Time Frame: Preoperative baseline through 3 weeks postoperatively ]
  • Postoperative Nausea Score (Visual Analog Scale) [ Time Frame: Preoperative baseline through 3 weeks postoperatively ]
  • Opioid Consumption [ Time Frame: Three weeks post-op ]
  • Antiemetic Consumption [ Time Frame: three weeks postoperatively ]
  • Length of Hospital Stay [ Time Frame: Perioperative/Periprocedural ]
  • Episodes of Nausea [ Time Frame: Three weeks postoperatively ]

Central Contacts and Locations

Central contacts

Antonio M Pellerito, BA

586-859-3258ampeller@umich.edu

Locations

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Antonio Pellerito, BA

586-859-3258ampeller@umich.edu

More Information

Sponsor

Henry Ford Health System

Last update posted

Oct 7, 2026

Last verified

Jun, 2026

Keywords

  • Total hip arthroplasty
  • Hip replacement
  • Opioid
  • Postoperative pain
  • Multimodal analgesia
  • Tramadol
  • Pain management
  • Opioid reduction
  • Patient reported outcomes
  • Orthopedic Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Henry Ford Health System on 2026-10-07. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.