Erector Spinae Plane Block Versus Quadratus Lumborum Block for Open Renal Surgeries in Children
19 de maio de 2022 atualizado por: Kareem Mohammed Assem Nawwar, Cairo University
Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block in Pediatric Open Renal Surgeries: A Randomized Comparative Study.
Open renal surgeries are associated with significant postoperative pain; early control of the perioperative pain is associated with decrease of hemodynamic variations during the surgery, early mobilization, better quality of functional recovery & early discharge of patients. Side effects of systemic opioids, as well as difficulty to monitor their response, are major limitations to their use.
Pediatric regional anesthesia (PRA) is one of the most valuable and safe tools to treat perioperative pain, and is an essential part of modern anesthetic practice. Neuraxial analgesia for pediatric patients is a mode of pain control that gained popularity in the last few decades as it decreases opioid exposure, shortens recovery room time & hospital stay. Caudal block is the most commonly used neuraxial anesthesia in pediatric patients. However, its major side effect is urinary retention and excessive motor block.
Considerable progress has been made in the practice of PRA over the past few years including incorporation of ultrasound guidance, with promising novel regional anesthesia techniques, especially the anterolateral and the posterolateral trunk blocks.
In this study, the investigators will compare the ultrasound guided quadratus lumborum block (QLB) with erector spinae plane block (ESPB), regarding the duration and quality of postoperative analgesia in pediatric patients undergoing unilateral open renal surgeries under general anesthesia. The study hypothesis is that QLB can provide a more superior postoperative pain relief to ESPB in children undergoing open renal surgeries.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Tipo de estudo
Intervencional
Inscrição (Antecipado)
60
Estágio
- Fase 4
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Kareem MA Nawwar, M.D.
- Número de telefone: +201003878369
- E-mail: drknawwar@cu.edu.eg
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
1 ano a 6 anos (Filho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- American society of anesthesiologists (ASA) class I and II
- Children undergoing unilateral open renal surgeries
Exclusion Criteria:
- Parents refusal for the block
- Bleeding disorders (platelets count < 100,000/uL; INR > 1.5; PC < 60%)
- Skin lesion, wounds or infection at the puncture site.
- Known allergy to local anesthetic drugs
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Erector spinae plane block (ESPB) group
30 child will receive a preoperative unilateral single shot US-guided erector spinae plane block at the level of T9 vertebra in the lateral position after induction of general anesthesia, using 0.5 mL/kg of bupivacaine 0.125%
|
Using a 22-gauge 80 mm echogenic needle under ultrasound guidance, 0.5 mL/kg of bupivacaine 0.125% will be injected in the fascial plane deep to erector spinae muscle after confirming correct needle location by a negative aspiration test then by injecting 0.5-1 ml saline and observing the fluid lifting the erector spinae muscle off the transverse process (hydrodissection).
The ultrasound probe will be placed 2-3 cm lateral to the spinous process on a parasagittal plane, to visualize the erector spinae muscle and transverse process, directing the needle craniocaudally using the in-plane technique.
The spread of the injectate will be observed to distribute within this plane.
Sonosite S-Nerve (USA) with a linear multi-frequency 6-13 MHz (hockey stick) transducer
A 22-gauge 80 mm needle the sonoplex needle manufactured by PAJUNK (USA)
Given intravenously (1 µg/kg) as part of induction of general anesthesia (GA) added to propofol 2 mg/kg and atracurium 0.5 mg/kg Intraoperatively, intravenous fentanyl 0.5 µg/kg (with a maximum dose of 2 µg/kg) will be administered in response to any increase in hemodynamics by more than 20% of baseline values in response to skin incision or there after throughout surgery (after exclusion of other causes of hemodynamic changes)
Will be given intravenously as a rescue analgesic (0.5 mg/kg with maximal dose 1.5 mg/kg) in both study groups if Children's Hospital Eastern Ontario Pain Scale (CHEOPS) more than 6.
Quality of postoperative analgesia will be assessed using CHEOPS pain score at time transfer to PACU, 15, 30 minutes then 1, 2, 4, 6 hours postoperatively.
|
|
Comparador Ativo: Quadratus lumborum block (QLB) group
30 child will receive a preoperative unilateral single shot US-guided quadratus lumborum block at the level of L2 spinous process in the lateral position after induction of general anesthesia, using 0.5 mL/kg of bupivacaine 0.125%
|
Sonosite S-Nerve (USA) with a linear multi-frequency 6-13 MHz (hockey stick) transducer
A 22-gauge 80 mm needle the sonoplex needle manufactured by PAJUNK (USA)
Given intravenously (1 µg/kg) as part of induction of general anesthesia (GA) added to propofol 2 mg/kg and atracurium 0.5 mg/kg Intraoperatively, intravenous fentanyl 0.5 µg/kg (with a maximum dose of 2 µg/kg) will be administered in response to any increase in hemodynamics by more than 20% of baseline values in response to skin incision or there after throughout surgery (after exclusion of other causes of hemodynamic changes)
Will be given intravenously as a rescue analgesic (0.5 mg/kg with maximal dose 1.5 mg/kg) in both study groups if Children's Hospital Eastern Ontario Pain Scale (CHEOPS) more than 6.
Quality of postoperative analgesia will be assessed using CHEOPS pain score at time transfer to PACU, 15, 30 minutes then 1, 2, 4, 6 hours postoperatively.
Using a 22-gauge 80 mm echogenic needle under ultrasound guidance, 0.5 mL/kg of bupivacaine 0.125% will be injected in the fascial plane between the quadratus lumborum and psoas major muscle after confirming correct needle location by a negative aspiration test then by injecting 0.5-1 ml saline (hydrodissection).
The ultrasound probe will be placed 2-3 cm lateral to the L2 spinous process on an axial plane, to visualize the transverse process with psoas major muscle anterior, quadratus lumborum muscle lateral and erector spinae muscle posterior to it.
The needle is inserted from the medial side of the probe and advanced laterally using the in-plane technique.
The spread of the injectate will be observed to distribute within the target plane.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Time to first postoperative rescue analgesia
Prazo: 12 hours
|
Time in minutes when postoperative Children's Hospital Eastern Ontario Pain Scale (CHEOPS) pain score exceeds 6 for the first time.
Children's Hospital Eastern Ontario Pain Scale is a pain score with the least possible score is 4, while the highest possible score 13 (worse outcome).
|
12 hours
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Total opioid analgesic consumption in the first 12 hours postoperative period
Prazo: from time of patient transfer to the PACU, till 12 hours postoperatively
|
when postoperative Children's Hospital Eastern Ontario Pain Scale (CHEOPS) pain score ˃ 6 in the first 12 hours postoperatively.
Children's Hospital Eastern Ontario Pain Scale is a pain score with the least possible score is 4, while the highest possible score 13 (worse outcome).
|
from time of patient transfer to the PACU, till 12 hours postoperatively
|
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Intraoperative mean arterial blood pressure
Prazo: During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block)
|
measured from induction of general anesthesia, after performance of the nerve block and at 1,5,10, 15 mins.
after
|
During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block)
|
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Intraoperative heart rate
Prazo: During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block)
|
measured before and after induction of general anesthesia, after performance of the nerve block and at 1,5,10, 15 mins.
after
|
During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block)
|
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Postoperative pain score
Prazo: from time of patient transfer to the PACU, till 12 hours postoperatively
|
measured at time of patient transfer to the PACU, 15, 30 mins, 1 ,2 , 4 ,6 ,12 hours after surgery
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from time of patient transfer to the PACU, till 12 hours postoperatively
|
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Block performance time
Prazo: Time from ultrasound visualization of target injection site to end of local anesthetic (bupivacaine) deposition up to 15 mins.
|
Time to perform ultrasound guided nerve block
|
Time from ultrasound visualization of target injection site to end of local anesthetic (bupivacaine) deposition up to 15 mins.
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Indirect signs of local anesthetic toxicity
Prazo: from time of local anesthetic (bupivacaine) deposition till 6 hours postoperatively
|
intraoperative arrhythmias and delayed awakening
|
from time of local anesthetic (bupivacaine) deposition till 6 hours postoperatively
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Cadeira de estudo: Nevine M Gouda, Cairo University
- Cadeira de estudo: Sherif M Soaida, Cairo University
- Cadeira de estudo: Ismail S Hammad, Cairo University
- Investigador principal: Ahmed T Bahnaswy, Cairo University
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Antecipado)
20 de maio de 2022
Conclusão Primária (Antecipado)
1 de setembro de 2022
Conclusão do estudo (Antecipado)
15 de setembro de 2022
Datas de inscrição no estudo
Enviado pela primeira vez
8 de maio de 2022
Enviado pela primeira vez que atendeu aos critérios de CQ
19 de maio de 2022
Primeira postagem (Real)
23 de maio de 2022
Atualizações de registro de estudo
Última Atualização Postada (Real)
23 de maio de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
19 de maio de 2022
Última verificação
1 de maio de 2022
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Processos Patológicos
- Complicações pós-operatórias
- Dor
- Manifestações Neurológicas
- Dor, Pós-operatório
- Dor aguda
- Efeitos Fisiológicos das Drogas
- Depressores do Sistema Nervoso Central
- Agentes do Sistema Nervoso Periférico
- Analgésicos
- Agentes do Sistema Sensorial
- Anestésicos Intravenosos
- Anestésicos Gerais
- Anestésicos
- Analgésicos, Opioides
- Narcóticos
- Adjuvantes, Anestesia
- Fentanil
- Meperidina
Outros números de identificação do estudo
- md-13-2022
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
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