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Arthroplasty, Replacement, HipNCT07672808

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

A study testing Standard Multimodal Analgesic Regimen with Opioid Prescription and Opioid-Reduced Multimodal Analgesic Regimen with Printed Prescription in people with Arthroplasty, Replacement, Hip, run by Henry Ford Health System at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arthroplasty, Replacement, Hip
What is being tested?
Standard Multimodal Analgesic Regimen with Opioid Prescription and Opioid-Reduced Multimodal Analgesic Regimen with Printed Prescription
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
20 Jul 2026to 30 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Antonio M Pellerito, BA contact

586-859-3258

ampeller@umich.edu

United States1 site, 1 recruiting
  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Antonio Pellerito, BA, 586-859-3258, ampeller@umich.edu

    Recruiting

Other trials in United States

About this study

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.

Being tested
Standard Multimodal Analgesic Regimen with Opioid Prescription, Opioid-Reduced Multimodal Analgesic Regimen with Printed Prescription
Keywords
Total hip arthroplasty, Hip replacement, Opioid, Postoperative pain, Multimodal analgesia, Tramadol, Pain management, Opioid reduction, Patient reported outcomes, Orthopedic Surgery
Medical subject headings
Pain, Postoperative, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard Multimodal Analgesic Regimen with Opioid PrescriptionDrug

    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 PrescriptionBehavioural

    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).

Study groups in NCT07672808
Study groupRoleWhat they receive
Standard Postoperative Pain Protocol (Control)Active comparatorParticipants 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.
Receives: Drug: Standard Multimodal Analgesic Regimen with Opioid Prescription
Opioid-Reduced Postoperative Pain Protocol (Treatment)ExperimentalParticipants 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.
Receives: Behavioral: Opioid-Reduced Multimodal Analgesic Regimen with Printed Prescription

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: three weeks postoperatively

  5. Length of Hospital Stay

    Total number of days from surgical admission to hospital discharge following primary total hip arthroplasty.

    Measured: Perioperative/Periprocedural

  6. Episodes of Nausea

    Number of nausea episodes documented. Inpatient episodes collected via electronic medical record; post-discharge episodes recorded by the patient in a postoperative pain journal.

    Measured: Three weeks postoperatively

Secondary outcomes (11)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: Prior to hospital discharge, assessed up to 2 weeks postoperatively

  5. Range of Motion (ROM)

    Hip range of motion measured in degrees at postoperative follow-up visits by the treating surgeon or clinical staff.

    Measured: up to three months postoperatively

  6. Distance Walked During Physical Therapy Sessions

    Total distance walked in feet or meters recorded by physical therapy during inpatient physical therapy sessions following surgery.

    Measured: Up to three months postoperatively

  7. Surgical Site Infection

    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.

    Measured: Up to three months postoperatively

  8. Acute Prosthetic Joint Infection

    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.

    Measured: Up to three months postoperatively

  9. Wound Dehiscence

    Occurrence of wound dehiscence at the surgical site following primary total hip arthroplasty, identified during clinical follow-up visits or by chart review.

    Measured: Up to three months postoperatively

  10. PROMIS Pain Interference

    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.

    Measured: Up to three months postoperatively

  11. PROMIS Emotional Distress: Depression

    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.

    Measured: Up to three months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2026
  2. Study start20 Jul 2026
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion30 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two-arm parallel randomized controlled trial comparing standard postoperative opioid prescription delivery versus printed opioid prescription only following total hip arthroplasty.
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07672808
Sponsor's protocol ID
14751-27
Status last verified
Jun 2026
First submitted
5 Jun 2026
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pirkle S, Reddy S, Bhattacharjee S, Shi LL, Lee MJ. Chronic Opioid Use Is Associated With Surgical Site Infection After Lumbar Fusion. Spine (Phila Pa 1976). 2020 Jun 15;45(12):837-842. doi: 10.1097/BRS.0000000000003405.

    PubMed 32032322
  • Bravo L, Mico JA, Berrocoso E. Discovery and development of tramadol for the treatment of pain. Expert Opin Drug Discov. 2017 Dec;12(12):1281-1291. doi: 10.1080/17460441.2017.1377697. Epub 2017 Sep 17.

    PubMed 28920461
  • Beakley BD, Kaye AM, Kaye AD. Tramadol, Pharmacology, Side Effects, and Serotonin Syndrome: A Review. Pain Physician. 2015 Jul-Aug;18(4):395-400.

    PubMed 26218943
  • Goldman AH, Griffis CE, Johnson DD, Balazs GC. Shifts in Prescribers' Initial Postoperative Opioid Prescriptions Following Primary Total Hip Arthroplasty Between 2014 and 2018. J Arthroplasty. 2020 Nov;35(11):3208-3213. doi: 10.1016/j.arth.2020.06.002. Epub 2020 Jun 10.

    PubMed 32622716
  • Moutzouros V, Jildeh TR, Khalil LS, Schwartz K, Hasan L, Matar RN, Okoroha KR. A Multimodal Protocol to Diminish Pain Following Common Orthopedic Sports Procedures: Can We Eliminate Postoperative Opioids? Arthroscopy. 2020 Aug;36(8):2249-2257. doi: 10.1016/j.arthro.2020.04.018. Epub 2020 Apr 28.

    PubMed 32353620
  • Cho CH, Song KS, Min BW, Lee KJ, Ha E, Lee YC, Lee YK. Multimodal approach to postoperative pain control in patients undergoing rotator cuff repair. Knee Surg Sports Traumatol Arthrosc. 2011 Oct;19(10):1744-8. doi: 10.1007/s00167-010-1294-y. Epub 2010 Oct 19.

    PubMed 20957469
  • Fiore JF Jr, Olleik G, El-Kefraoui C, Verdolin B, Kouyoumdjian A, Alldrit A, Figueiredo AG, Valanci S, Marquez-GdeV JA, Schulz M, Moldoveanu D, Nguyen-Powanda P, Best G, Banks A, Landry T, Pecorelli N, Baldini G, Feldman LS. Preventing opioid prescription after major surgery: a scoping review of opioid-free analgesia. Br J Anaesth. 2019 Nov;123(5):627-636. doi: 10.1016/j.bja.2019.08.014. Epub 2019 Sep 25.

    PubMed 31563269
  • Fiore JF Jr, El-Kefraoui C, Chay MA, Nguyen-Powanda P, Do U, Olleik G, Rajabiyazdi F, Kouyoumdjian A, Derksen A, Landry T, Amar-Zifkin A, Bergeron A, Ramanakumar AV, Martel M, Lee L, Baldini G, Feldman LS. Opioid versus opioid-free analgesia after surgical discharge: a systematic review and meta-analysis of randomised trials. Lancet. 2022 Jun 18;399(10343):2280-2293. doi: 10.1016/S0140-6736(22)00582-7.

    PubMed 35717988
  • Chia PA, Cannesson M, Bui CCM. Opioid free anesthesia: feasible? Curr Opin Anaesthesiol. 2020 Aug;33(4):512-517. doi: 10.1097/ACO.0000000000000878.

    PubMed 32530891
  • Scully RE, Schoenfeld AJ, Jiang W, Lipsitz S, Chaudhary MA, Learn PA, Koehlmoos T, Haider AH, Nguyen LL. Defining Optimal Length of Opioid Pain Medication Prescription After Common Surgical Procedures. JAMA Surg. 2018 Jan 1;153(1):37-43. doi: 10.1001/jamasurg.2017.3132.

    PubMed 28973092

Questions about this trial

What is this clinical trial studying?

A study testing Standard Multimodal Analgesic Regimen with Opioid Prescription and Opioid-Reduced Multimodal Analgesic Regimen with Printed Prescription in people with Arthroplasty, Replacement, Hip, run by Henry Ford Health System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Antonio M Pellerito, BA (586-859-3258, ampeller@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Pain Score (Visual Analog Scale) (time frame: Preoperative baseline through 3 weeks postoperatively). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07672808, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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