Multimodal Analgesic Regimen for Total Hip Arthroplasty: An Initiative to Minimize Postoperative Opioid Use
22 de junio de 2026 actualizado por: Michael Charters, MD, Henry Ford Health System
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Estimado)
100
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Antonio M Pellerito, BA
- Número de teléfono: 586-859-3258
- Correo electrónico: ampeller@umich.edu
Ubicaciones de estudio
-
-
Michigan
-
Detroit, Michigan, Estados Unidos, 48202
- Henry Ford Hospital
-
Contacto:
- Antonio Pellerito, BA
- Número de teléfono: 586-859-3258
- Correo electrónico: ampeller@umich.edu
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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.
|
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.
|
|
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.
|
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).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Postoperative Pain Score (Visual Analog Scale)
Periodo de tiempo: 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.
|
Preoperative baseline through 3 weeks postoperatively
|
|
Postoperative Nausea Score (Visual Analog Scale)
Periodo de tiempo: 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.
|
Preoperative baseline through 3 weeks postoperatively
|
|
Opioid Consumption
Periodo de tiempo: 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.
|
Three weeks post-op
|
|
Antiemetic Consumption
Periodo de tiempo: 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.
|
three weeks postoperatively
|
|
Length of Hospital Stay
Periodo de tiempo: Perioperative/Periprocedural
|
Total number of days from surgical admission to hospital discharge following primary total hip arthroplasty.
|
Perioperative/Periprocedural
|
|
Episodes of Nausea
Periodo de tiempo: 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.
|
Three weeks postoperatively
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Hip Injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR.)
Periodo de tiempo: 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.
|
Up to three months postoperatively
|
|
Harris Hip Score
Periodo de tiempo: 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.
|
Up to three months postoperatively
|
|
PROMIS Physical Function
Periodo de tiempo: 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.
|
Up to three months postoperatively
|
|
Timed Up and Go Test (TUG)
Periodo de tiempo: 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
|
Prior to hospital discharge, assessed up to 2 weeks postoperatively
|
|
Range of Motion (ROM)
Periodo de tiempo: up to three months postoperatively
|
Hip range of motion measured in degrees at postoperative follow-up visits by the treating surgeon or clinical staff.
|
up to three months postoperatively
|
|
Distance Walked During Physical Therapy Sessions
Periodo de tiempo: Up to three months postoperatively
|
Total distance walked in feet or meters recorded by physical therapy during inpatient physical therapy sessions following surgery.
|
Up to three months postoperatively
|
|
Surgical Site Infection
Periodo de tiempo: 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.
|
Up to three months postoperatively
|
|
Acute Prosthetic Joint Infection
Periodo de tiempo: 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.
|
Up to three months postoperatively
|
|
Wound Dehiscence
Periodo de tiempo: 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.
|
Up to three months postoperatively
|
|
PROMIS Pain Interference
Periodo de tiempo: 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.
|
Up to three months postoperatively
|
|
PROMIS Emotional Distress: Depression
Periodo de tiempo: 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.
|
Up to three months postoperatively
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Michael Charters, MD, Henry Ford Health System
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Beakley BD, Kaye AM, Kaye AD. Tramadol, Pharmacology, Side Effects, and Serotonin Syndrome: A Review. Pain Physician. 2015 Jul-Aug;18(4):395-400.
- 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.
- 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.
- 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.
- 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.
- Chia PA, Cannesson M, Bui CCM. Opioid free anesthesia: feasible? Curr Opin Anaesthesiol. 2020 Aug;33(4):512-517. doi: 10.1097/ACO.0000000000000878.
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de junio de 2026
Finalización primaria (Estimado)
1 de diciembre de 2026
Finalización del estudio (Estimado)
30 de mayo de 2027
Fechas de registro del estudio
Enviado por primera vez
5 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
22 de junio de 2026
Publicado por primera vez (Actual)
29 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
29 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
22 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 14751-27
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .