Arthroplasty, Replacement, Hip
Conditions
Keywords
Total hip arthroplasty, Hip replacement, Opioid, Postoperative pain, Multimodal analgesia, Tramadol, Pain management, Opioid reduction, Patient reported outcomes, Orthopedic Surgery
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.
Interventions
DRUGStandard 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.
BEHAVIORALOpioid-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).
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two-arm parallel randomized controlled trial comparing standard postoperative opioid prescription delivery versus printed opioid prescription only following total hip arthroplasty.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Score (Visual Analog Scale) | Preoperative baseline through 3 weeks postoperatively | 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. |
| Postoperative Nausea Score (Visual Analog Scale) | Preoperative baseline through 3 weeks postoperatively | 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. |
| Opioid Consumption | Three weeks post-op | 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. |
| Antiemetic Consumption | three weeks postoperatively | 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. |
| Length of Hospital Stay | Perioperative/Periprocedural | Total number of days from surgical admission to hospital discharge following primary total hip arthroplasty. |
| Episodes of Nausea | Three weeks postoperatively | Number of nausea episodes documented. Inpatient episodes collected via electronic medical record; post-discharge episodes recorded by the patient in a postoperative pain journal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hip Injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR.) | Up to three months postoperatively | 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. |
| Harris Hip Score | Up to three months postoperatively | 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. |
| PROMIS Physical Function | Up to three months postoperatively | 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. |
| Timed Up and Go Test (TUG) | Prior to hospital discharge, assessed up to 2 weeks postoperatively | 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 |
| Range of Motion (ROM) | up to three months postoperatively | Hip range of motion measured in degrees at postoperative follow-up visits by the treating surgeon or clinical staff. |
| Distance Walked During Physical Therapy Sessions | Up to three months postoperatively | Total distance walked in feet or meters recorded by physical therapy during inpatient physical therapy sessions following surgery. |
| Surgical Site Infection | Up to three months postoperatively | Occurrence of superficial or deep surgical site infection at the operative site following primary total hip arthroplasty, identified during clinical follow-up visits or by chart review. |
| Acute Prosthetic Joint Infection | Up to three months postoperatively | Occurrence of acute periprosthetic joint infection following primary total hip arthroplasty, identified during clinical follow-up visits or by chart review per standard clinical criteria. |
| Wound Dehiscence | Up to three months postoperatively | Occurrence of wound dehiscence at the surgical site following primary total hip arthroplasty, identified during clinical follow-up visits or by chart review. |
| PROMIS Pain Interference | Up to three months postoperatively | Patient-reported outcome measure assessing the degree to which pain interferes with daily activities and social participation. Administered via the PROMIS Pain Interference 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 greater pain interference. |
| PROMIS Emotional Distress: Depression | Up to three months postoperatively | Patient-reported outcome measure assessing depressive symptoms including helplessness, hopelessness, and emotional exhaustion. Administered via the PROMIS Emotional Distress. Depression 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 greater emotional distress. |
Countries
United States
Contacts
CONTACTAntonio M Pellerito, BA
PRINCIPAL_INVESTIGATORMichael Charters, MD
Henry Ford Health System
Outcome results
None listed