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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07705230
Ultrasound Guided Combined Adductor Canal, Superior Genicular Nerves and Anterior Femoral Cutaneous Nerves Blocks in Comparison With Periarticular Local Anesthesia Infiltration in Primary Total Knee Arthroplasty
Analgesic Efficacy of Ultrasound Guided Combined Adductor Canal, Superior Genicular Nerves and Anterior Femoral Cutaneous Nerves Blocks in Comparison With Periarticular Local Anesthesia Infiltration in Primary Total Knee Arthroplasty: A Prospective Randomized Trial
Background:
Pain management in total knee arthroplasty continues to evolve especially as an early postoperative analgesia is of paramount importance in achieving patient satisfaction and improving clinical outcomes. The goal of achieving an ideal analgesia modality which facilitates early rehabilitation, prevents knee stiffness, reduces hospital stay due to pain, and promotes good functional outcomes continues to be elusive. Multimodal analgesia has been devised to control postoperative pain and reduce opioid consumption including periarticular injection and peripheral nerve blocks.
Rationale:
Assess the efficacy of a triple block including Adductor canal block, superior lateral, superior medial genicular nerves block and anterior femoral cutaneous nerves block in comparison with Periarticular infiltration for pain management in patients undergoing a total knee arthroplasty.
Methods:
Prospective Randomized Control Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Pain management after total knee arthroplasty continues to evolve, as effective early postoperative analgesia is essential for patient satisfaction, early mobilization, improved functional outcomes, and reduced hospital stay. Multimodal analgesia strategies have been developed to optimize pain control while minimizing opioid consumption, including periarticular injection and peripheral nerve blocks.
Femoral nerve block has traditionally been used for analgesia after total knee arthroplasty; however, its associated quadriceps weakness may delay mobilization and increase the risk of falls. Consequently, the adductor canal block has gained popularity because it provides predominantly sensory blockade while preserving quadriceps muscle strength.
The sensory innervation of the knee joint is complex and involves branches from the femoral, tibial, common peroneal, saphenous, and obturator nerves. Genicular nerve blocks specifically target the sensory innervation of the knee capsule and have emerged as a promising technique for postoperative pain management. In this study, higher volumes of local anesthetic will be used for the superior genicular nerve blocks to improve coverage of the posterior knee capsule, while the inferolateral genicular nerve block will be avoided because of the potential risk of motor weakness and foot drop.
As the medial parapatellar approach is the most common surgical approach for total knee arthroplasty, the anterior femoral cutaneous nerve, which supplies the anteromedial aspect of the distal thigh and knee, may represent an additional target for postoperative analgesia.
Periarticular injection is a surgeon-administered analgesic technique that provides effective early postoperative pain relief without affecting quadriceps strength and has become widely adopted in total knee arthroplasty.
The aim of this study is to compare the analgesic efficacy of a combined approach using adductor canal block, superior genicular nerve blocks, and anterior femoral cutaneous nerve block with periarticular injection in patients undergoing total knee arthroplasty. We hypothesize that adding superior genicular nerve blocks and anterior femoral cutaneous nerve block to adductor canal block will provide superior postoperative analgesia compared with periarticular injection.
A prospective randomized blinded trial will be conducted at Qassim University Hospital after obtaining written informed consent. Adult patients undergoing primary unilateral total knee replacement, aged above 18 years, with a body mass index below 40 kg/m² and American Society of Anesthesiologists physical status I-II will be included. Patients with contraindications to spinal anesthesia, allergy to study medications, opioid dependence, previous knee surgery, chronic neuropathic pain, or regular use of analgesics other than nonsteroidal anti-inflammatory drugs will be excluded.
All patients will undergo routine preoperative assessment and laboratory investigations. In the operating room, standard monitoring will be applied, intravenous access established, and crystalloid infusion commenced.
Spinal anesthesia will be performed under aseptic conditions using hyperbaric bupivacaine, followed by intravenous sedation with midazolam, fentanyl, and propofol infusion. All patients will receive prophylactic antibiotics and tranexamic acid, with supplemental oxygen and capnography monitoring throughout the procedure.
All surgeries will be performed using a standardized surgical technique by the same surgical team, while regional anesthesia procedures will be performed by the same anesthesiologists. Outcome assessors and data analysts will remain blinded to group allocation.
Postoperative analgesia will include regular paracetamol and ketorolac, with intravenous morphine provided as rescue analgesia when required. After discharge, patients will receive oral paracetamol and celecoxib, with tramadol and antiemetics prescribed as needed.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Al-Qassim Region
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Buraidah, Al-Qassim Region, Arabia Saudita
- Qassim University Medical City
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- ASA: I & II
- Gender: Male & Female
- Age: 18and above
- BMI less than 40 kg/m2
- Patients are scheduled for primary unilateral total knee arthroplasty.
Exclusion Criteria:
- Patients with contraindications to spinal anesthesia
- Failed spinal anesthesia.
- ASA III-IV
- Body mass index (BMI)≥40,
- A known allergy or contraindication to the drugs used in this study.
- Previous knee surgery.
- Renal impairment.
- Patients who suffer from chronic neuropathic pain or on regular pain medications other than NSAIDs.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Periarticular Infiltration Analgesia Group
It will be infiltrated by the surgeon before prosthesis implantation.
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A total volume of 60 mL containing bupivacaine, ketorolac, adrenaline, and tranexamic acid will be infiltrated by the surgeon before prosthesis implantation into the posterior capsule, medial and lateral gutters, quadriceps mechanism, patellar tendon, and medial periosteum.
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Comparador activo: Triple Block Group
Patients will receive ultrasound-guided adductor canal, infrapatellar, medial cutaneous, and superior genicular nerve blocks.
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Patients will receive a mixture of 45 mL of 0.25% bupivacaine and 8 mg dexamethasone.
A total of 15 mL will be injected into the adductor canal, 10 mL for the infrapatellar and medial cutaneous nerve blocks, and 10 mL each for the superior medial and superior lateral genicular nerve blocks.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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End of Analgesia Time
Periodo de tiempo: Within the first 24 hours after surgery.
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Time from the end of surgery until the first Numeric Rating Scale (NRS) pain score ≥ 4.
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Within the first 24 hours after surgery.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Total Morphine Consumption (mg)
Periodo de tiempo: During the first 24 hours after surgery
|
Total cumulative morphine consumption during hospital stay
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During the first 24 hours after surgery
|
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Total Tramadol Consumption (mg)
Periodo de tiempo: During the first 24 hours after discharge
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Total tramadol consumption after hospital discharge
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During the first 24 hours after discharge
|
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Heart rate (Beat/minute)
Periodo de tiempo: During the first 24 hours after surgery
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Heart rate measurements recorded postoperatively every 30 minutes in the recovery unit, then hourly in the day surgery unit until discharge.
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During the first 24 hours after surgery
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Blood pressure (mmHg)
Periodo de tiempo: During the first 24 hours after surgery
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Blood pressure measurements recorded postoperatively every 30 minutes in the recovery unit, then hourly in the day surgery unit until discharge.
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During the first 24 hours after surgery
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Patient Satisfaction Score
Periodo de tiempo: At 24 hours after surgery
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Patient satisfaction with postoperative analgesia assessed using a five-point Likert scale (range: 1 to 5), where 1 indicates very dissatisfied and 5 indicates very satisfied.
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At 24 hours after surgery
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Length of Hospital Stay
Periodo de tiempo: During the index hospitalization up to 3 days postoperatively
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Duration from operating room admission until hospital discharge.
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During the index hospitalization up to 3 days postoperatively
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: OMAR S Almisnid, Anesthesia Consultant, Department of Anesthesia, College of Medicine, Qassim University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Otros números de identificación del estudio
- REGIONAL BLOCKS IN TKA
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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