Multimodal Analgesic Regimen for Total Hip Arthroplasty: An Initiative to Minimize Postoperative Opioid Use

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHenry Ford Health System

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients age 18 and older

Patients who have undergone total hip arthroplasty by a single, fellowship trained Orthopaedic Surgeon.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard Multimodal Analgesic Regimen with Opioid Prescription

    Drug

    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

    Behavioral

    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).

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Standard Postoperative Pain Protocol (Control)Active comparator 1 intervention
Group B: Opioid-Reduced Postoperative Pain Protocol (Treatment)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative Pain Score (Visual Analog Scale)

Pain severity measured using a visual analog scale (VAS) scored 0-10, where 0 represents no pain and 10 represents the worst possible pain. Scores collected preoperatively, daily during inpatient admission, daily for the first week post-discharge, then weekly for 2 additional weeks via patient pain journal and phone/text check-ins.

Time frame
Preoperative baseline through 3 weeks postoperatively
2

Postoperative Nausea Score (Visual Analog Scale)

Nausea severity measured using a visual analog scale (VAS) scored 0-10, where 0 represents no nausea and 10 represents the worst possible nausea. Scores collected preoperatively, daily during inpatient admission, daily for the first week post-discharge, then weekly for 2 additional weeks via patient pain journal and phone/text check-ins.

Time frame
Preoperative baseline through 3 weeks postoperatively
3

Opioid Consumption

Total opioid consumption measured in morphine milligram equivalents (MME) and by dose and quantity. Inpatient opioid use collected via electronic medical record and the Michigan Automated Prescription System (MAPS). Post-discharge opioid use recorded by the patient in a postoperative pain journal.

Time frame
Three weeks post-op
4

Antiemetic Consumption

Total antiemetic consumption recorded by dose and quantity. Inpatient use collected via electronic medical record; post-discharge use recorded by the patient in a postoperative pain journal.

Time frame
three weeks postoperatively

Secondary outcomes

1

Hip Injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR.)

Patient-reported outcome measure assessing hip pain and function specific to joint replacement patients. Scored on a 0-100 scale, with higher scores indicating better hip function. Administered at scheduled postoperative follow-up visits.

Time frame
Up to three months postoperatively
2

Harris Hip Score

Clinician-administered outcome measure assessing hip pain, function, absence of deformity, and range of motion following total hip arthroplasty. Scored on a scale of 0 to 100, where higher scores indicate better hip function and outcomes.

Time frame
Up to three months postoperatively
3

PROMIS Physical Function

Patient-reported outcome measure assessing self-reported capability to perform physical activities. Administered via the PROMIS Physical Function item bank at scheduled postoperative follow-up visits. Scores are reported as T-scores with a mean of 50 and standard deviation of 10 in the general population, where higher scores indicate better physical function.

Time frame
Up to three months postoperatively
4

Timed Up and Go Test (TUG)

Functional mobility test measuring the time in seconds for a patient to rise from a chair, walk 3 meters, turn, walk back, and sit down. Administered by physical therapy prior to hospital discharge

Time frame
Prior to hospital discharge, assessed up to 2 weeks postoperatively

Other outcomes

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