Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty (THA)
Comparison of the Efficacy and Safety of Three Regional Anesthesia Strategies in Patients Undergoing Elective Total Hip Arthroplasty: A Prospective, Randomized, Multicenter Clinical Trial
The goal of this clinical trial is to learn which of three regional anesthesia approaches provides better pain relief and safety for older adults having planned hip replacement surgery. Researchers will study people aged 60 years and older who are scheduled for elective total hip arthroplasty.
The main questions this study aims to answer are:
Which anesthesia method provides better pain control after surgery? Which method reduces the need for opioid pain medicines? Are there differences in side effects and recovery between the approaches? Participants will be randomly assigned to one of three groups. All participants will receive spinal anesthesia. One group will receive spinal anesthesia with intrathecal morphine. The other two groups will receive spinal anesthesia combined with a nerve block called the pericapsular nerve group (PENG) block, with or without the addition of dexamethasone.
Participants will have their pain levels measured at regular times during the first two days after surgery. Researchers will also record opioid use, time to first pain medication, ability to move after surgery, length of hospital stay, and any side effects such as nausea or itching. Blood tests will be used to measure markers of inflammation.
The results of this study may help doctors choose safer and more effective pain control strategies for people undergoing hip replacement surgery.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Postoperative pain after total hip arthroplasty is associated with increased opioid use, delayed mobilization, and a higher risk of adverse events, particularly in older adults. Spinal anesthesia with intrathecal morphine is widely used to improve postoperative analgesia; however, it may be associated with opioid-related side effects such as nausea, pruritus, urinary retention, and respiratory depression. Ultrasound-guided regional nerve blocks, including the pericapsular nerve group (PENG) block, have emerged as opioid-sparing alternatives that may provide effective analgesia while preserving motor function.
This prospective, randomized, multicenter clinical trial is designed to compare the efficacy and safety of three regional anesthesia strategies in patients undergoing elective total hip arthroplasty. Participants aged 60 years and older will be randomly assigned in a 1:1:1 ratio to one of three study groups: spinal anesthesia with intrathecal morphine; spinal anesthesia combined with a PENG block; or spinal anesthesia combined with a PENG block using perineural dexamethasone as an adjuvant.
All participants will receive standardized spinal anesthesia with ropivacaine. In the control group, intrathecal morphine will be administered as part of routine spinal anesthesia. In the intervention groups, the PENG block will be performed under ultrasound guidance using ropivacaine, with or without the addition of dexamethasone. Perioperative care, postoperative analgesic protocols, and rehabilitation pathways will be standardized across all study centers to minimize variability.
Pain intensity at rest and during movement will be assessed using a visual analog scale at predefined time points within the first 48 hours after surgery. Secondary outcomes include total opioid consumption, time to first rescue analgesia, early mobilization, length of hospital stay, incidence of opioid-related and block-related adverse events, and changes in inflammatory markers measured in peripheral blood.
The results of this study will provide comparative evidence on opioid-based versus opioid-sparing regional anesthesia strategies for hip arthroplasty and may help inform clinical decision-making aimed at improving postoperative pain control, functional recovery, and safety in older surgical patients.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Malgorzata Reysenr, MD PhD
- Número de teléfono: 608762068
- Correo electrónico: mreysner@ump.edu.pl
Copia de seguridad de contactos de estudio
- Nombre: Malgorzata Reysner, MD PhD
- Número de teléfono: 608762068
- Correo electrónico: mreysner@ump.edu.pl
Ubicaciones de estudio
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Poznan, Polonia, 62-701
- Poznan University of Medical Sciences
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adults aged 60 to 100 years
- Scheduled for elective total hip arthroplasty
- American Society of Anesthesiologists (ASA) physical status I-III
- Ability to understand the study procedures and provide written informed consent
Exclusion Criteria:
- Known allergy or hypersensitivity to ropivacaine, morphine, or dexamethasone
- Coagulation disorders or ongoing anticoagulant therapy contraindicating spinal anesthesia or regional nerve blocks
- Infection at the site of spinal or peripheral nerve block injection
- Pre-existing neurological disorders affecting sensory or motor function
- Severe hepatic or renal insufficiency
- Chronic opioid use for more than 3 months prior to surgery
- Refusal or inability to provide informed consent
Plan de estudios
¿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 |
|---|---|
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Comparador activo: Spinal Anesthesia With Intrathecal Morphine
Participants will receive spinal anesthesia with intrathecal ropivacaine combined with intrathecal morphine.
Ropivacaine 0.5% (10-15 mg) will be administered intrathecally, followed by intrathecal morphine at a dose of 100 micrograms as part of standard anesthesia care.
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Intrathecal morphine administered as part of spinal anesthesia for postoperative pain control during elective total hip arthroplasty.
Otros nombres:
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Experimental: Spinal Anesthesia Plus PENG Block
Participants will receive spinal anesthesia with intrathecal ropivacaine 0.5% (10-15 mg) combined with an ultrasound-guided pericapsular nerve group (PENG) block.
The PENG block will be performed using 20 mL of ropivacaine 0.2% administered as a single injection.
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Ultrasound-guided pericapsular nerve group block performed as an adjunct to spinal anesthesia to provide postoperative analgesia.
Otros nombres:
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Experimental: Spinal Anesthesia Plus PENG Block With Dexamethasone
Participants will receive spinal anesthesia with intrathecal ropivacaine 0.5% (10-15 mg) combined with an ultrasound-guided pericapsular nerve group (PENG) block.
The PENG block will be performed using 20 mL of ropivacaine 0.2% with the addition of dexamethasone 4 mg administered perineurally as a single injection.
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Perineural dexamethasone administered as an adjuvant to the pericapsular nerve group block to prolong postoperative analgesia.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Total Postoperative Opioid Consumption
Periodo de tiempo: Up to 48 hours after surgery
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Total amount of opioids administered postoperatively, expressed as intravenous morphine equivalents.
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Up to 48 hours after surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain scores at rest
Periodo de tiempo: 6 hours after surgery
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Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
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6 hours after surgery
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Pain scores durring movement
Periodo de tiempo: 6 hours after surgery
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Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
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6 hours after surgery
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Pain scores at rest
Periodo de tiempo: 12 hours after surgery
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Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
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12 hours after surgery
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Pain scores durring movement
Periodo de tiempo: 12 hours after surgery
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Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
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12 hours after surgery
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Pain scores at rest
Periodo de tiempo: 24 hours after surgery
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Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
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24 hours after surgery
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Pain scores durring movement
Periodo de tiempo: 24 hours after surgery
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Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
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24 hours after surgery
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Pain scores at rest
Periodo de tiempo: 48 hours after surgery
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Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
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48 hours after surgery
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Pain scores durring movement
Periodo de tiempo: 48 hours after surgery
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Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization
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48 hours after surgery
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Time to First Rescue Analgesia
Periodo de tiempo: Up to 48 hours after surgery.
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Time from the end of surgery to the first request for rescue analgesic medication.
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Up to 48 hours after surgery.
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Early Mobilization
Periodo de tiempo: Up to 48 hours after surgery
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Time to first mobilization assessed using the Timed Up and Go test.
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Up to 48 hours after surgery
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Incidence of Opioid-Related Adverse Events
Periodo de tiempo: Up to 48 hours after surgery.
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Occurrence of opioid-related adverse events, including nausea, vomiting, pruritus, and urinary retention.
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Up to 48 hours after surgery.
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Length of Hospital Stay
Periodo de tiempo: measured at the day of the discharge from the hospital
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Total duration of postoperative hospitalization measured in days.
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measured at the day of the discharge from the hospital
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Malgorzata Reysner, MD PhD, Poznan University of Medical Sciences
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades musculoesqueléticas
- Artritis
- Enfermedades Articulares
- Enfermedades reumáticas
- Osteoartritis
- Artrosis, Cadera
- Compuestos heterocíclicos
- Compuestos heterocíclicos, anillo fusionado
- Alcaloides
- Hidrocarburos aromáticos policíclicos
- Compuestos policíclicos
- Espierra
- Embarazos
- Esteroides
- Compuestos de anillo fusionado
- Esteroides, fluorado
- Esparrazadienetrioles
- Compuestos heterocíclicos, 4 o más anillos
- Morfinanos
- Alcaloides opiáceos
- Compuestos heterocíclicos, anillo puente
- Fenantrenos
- Derivados de morfina
- Dexametasona
- Morfina
Otros números de identificación del estudio
- 1/2026 (Powiślańska Akademia Nauk Stosowanych w Kwidzynie)
Información sobre medicamentos y dispositivos, documentos del estudio
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