Comparison Between Erector Spinae Plane Block vs Transversus Abdominis Plane Block for Postoperative Analgesia in Cesarean Section
Erector Spinae Plane Block Versus Transversus Abdominis Plane Block For Postoperative Analgesia In Cesarean Section: Comparative Randomized Prospective Study
This study is a prospective randomized controlled trial designed to compare the effectiveness of the erector spinae plane (ESP) block versus the transversus abdominis plane (TAP) block for postoperative analgesia in patients undergoing cesarean section under spinal anesthesia. Sixty patients will be randomly allocated into two equal groups to receive either ESP or TAP block after surgery.
The primary outcome of the study is the assessment of postoperative pain using the Numeric Rating Scale (NRS) over the first 24 hours. Secondary outcomes include total morphine consumption, time to first request for rescue analgesia, patient satisfaction, incidence of complications, and hemodynamic stability.
All patients will receive standardized spinal anesthesia followed by the assigned block using a combination of bupivacaine and lidocaine under ultrasound guidance. Postoperatively, a multimodal analgesic regimen will be applied, including regular paracetamol and rescue analgesia with ketorolac or morphine based on pain scores.
The rationale of the study is based on the limitation of the TAP block in providing only somatic analgesia, whereas the ESP block may offer both somatic and visceral pain control due to its wider spread. Therefore, the study aims to determine whether ESP block provides superior postoperative analgesia and reduces opioid requirements compared to TAP block after cesarean delivery.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mohamed ali Elyamany, resident
- Número de teléfono: 01061646235
- Correo electrónico: aboelyamany@gmail.com
Ubicaciones de estudio
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Sohag, Egipto
- Sohag faculty of medicine
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Contacto:
- mohamed elyamany, resident
- Número de teléfono: 01061646235
- Correo electrónico: aboelyamany@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Age from 18 to 40 years old.
- Pregnant women.
- Scheduled for lower-segment cesarean section.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Singleton pregnancy at ≥37 weeks' gestation.
Exclusion Criteria:
• Contraindications to regional blocks or local anesthetics.
- History of chronic analgesic use or opioid dependency.
- Coagulopathy or anticoagulant therapy.
- Local infection at the injection site.
- Allergy to study medications.
- Patient refusal.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: ESPB group
patients included in this group will receive the erector spinae plane block.
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For the ESP block, patients will be placed in the right lateral decubitus position, and the T9 transverse process will be identified using a high-frequency linear ultrasound probe positioned 2-3 cm lateral to the midline in a parasagittal orientation.
After skin sterilization, a 21-gauge echogenic block needle will be advanced in-plane cranio-caudally until contact with the transverse process is achieved.
Hydrodissection with sterile saline will be performed to confirm correct fascial plane placement beneath the erector spinae muscle.
A total of 20 mL local anesthetic mixture will be administered on each side, consisting of 10 mL bupivacaine 0.25%- and 10-mL lidocaine 0.5%, ensuring that the maximum safe dose is not exceeded.
Correct spread will be confirmed under ultrasound by observing separation of the fascial layers.
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Comparador activo: TAP group
patients included in this group will receive the transversus abdominis plane block.
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For the TAP block, patients will be placed supine, and the posterior approach will be used with the probe placed midway between the subcostal margin and the iliac crest in the anterior axillary line.
The fascial plane between the internal oblique and transversus abdominis muscles will be visualized until it tapers toward the quadratus lumborum.
A 21-gauge echogenic needle will be introduced in-plane from anterior to posterior, and hydrodissection with sterile saline will be performed to confirm the correct plane.
A total of 20 mL local anesthetic mixture will be administered per side, composed of 10 mL bupivacaine 0.25%- and 10-mL lidocaine 0.5%, with care taken to remain within safe dosage limits.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Postoperative pain scores assessment using the Numeric Rating Scale (NRS).
Periodo de tiempo: Postoperative pain scores will be assessed using the Numeric Rating Scale (NRS) at 2, 4, 6, 12 and 24 hours only.
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Postoperative pain scores will be assessed using the Numeric Rating Scale (NRS) at 2, 4, 6, 12 and 24 hours only.
Pain scores will be evaluated both at rest and during movement.Patients will be informed about Numerical Rating Scale (NRS) and asked to circle the number between 0 and 10, Zero means no pain and ten means the worst pain].
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Postoperative pain scores will be assessed using the Numeric Rating Scale (NRS) at 2, 4, 6, 12 and 24 hours only.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Total morphine consumption
Periodo de tiempo: the first 24 hours postoperatively.
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• Total morphine consumption in the first 24 hours postoperatively.
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the first 24 hours postoperatively.
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Time to first request for rescue analgesia.
Periodo de tiempo: during the first 24 postoperative hours.
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during the first 24 postoperative hours.
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Patient satisfaction scores
Periodo de tiempo: at 24 hours.
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Degree of patient satisfaction will be assessed on a 5-point likert scale Patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied ; 5, extremely satisfied) (10).
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at 24 hours.
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Incidence of block-related complications
Periodo de tiempo: first 24 hours postoperatively.
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Adverse events: local anesthetic systemic toxicity (LAST), bradycardia, hypotension, nausea, vomiting, respiratory depression or any other complication.
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first 24 hours postoperatively.
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Colaboradores e Investigadores
Patrocinador
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- soh-Med-26-3-10MS
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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