- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07582640
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.
Visão geral do estudo
Status
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Mohamed ali Elyamany, resident
- Número de telefone: 01061646235
- E-mail: aboelyamany@gmail.com
Locais de estudo
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Sohag, Egito
- Sohag faculty of medicine
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Contato:
- mohamed elyamany, resident
- Número de telefone: 01061646235
- E-mail: aboelyamany@gmail.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: 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 Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Postoperative pain scores assessment using the Numeric Rating Scale (NRS).
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Total morphine consumption
Prazo: 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.
Prazo: during the first 24 postoperative hours.
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during the first 24 postoperative hours.
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Patient satisfaction scores
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- soh-Med-26-3-10MS
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