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- Ensaio Clínico NCT05080985
Paravertebral Block Versus Erector Spinae Plane Block for Analgesia in Modified Radical Mastectomy
Paravertebral Block Versus Erector Spinae Plane Block for Analgesia and Opioid Consumption in Modified Radical Mastectomy; Randomized, Prospective, Double Blind
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
A total of 86 patients were randomized into TPVB (Group P) and ESPB (Group E) by using closed envelopes.
All patients in the operating room has same anesthetic management under standard monitoring modalities. Prior to regional technique, mild sedation was achieved with midazolam (1-2 mg) and fentanyl (50 mcg). Both blocks were performed under ultrasonography guidance from the level of T4 vertebra with a linear probe (5MHz; GE Healthcare, Wauwatosa, Wis, USA) using longitudinally out-of-plane technique by an anesthesiologist. A 22-gauge, 50 mm insulated stimulating needle was used.By using reference points of C7 and T7, spinous processes of thoracic vertebras were marked. 10% povidone iodine was used for skin antisepsis. USG probe was longitudinally placed at the level of T4. Staff anesthesiologist had to visualize of adjacent muscles, transverse process (TP) and pleura.
For ESPB; confirmation of the needle position was achieved with spread of 2 ml saline between the deep fascia of the erector spinae muscle and the TP. After negative aspiration 20 ml 0.375% bupivacaine was injected with appropriate distribution of LA.
For TPVB; the needle was advanced passing over superior costotransverse ligament and target space was confirmed by the downward displacement of pleura after the administration of 2 ml 0.9% NaCl. After negative aspiration, 20 ml 0.375 % bupivacaine was injected with appropriate distribution of local anesthetics.
Vascular puncture, haematoma, neuraxial injury and pneumothorax were defined as block complications and should be noted.
30 minutes after the block achieved, pinprick test was performed on both mid-axillary and midclavicular lines from T1 to T12 (0 there is sensation, 1 decreased sensation, 2 there is no sensation).
Anesthesia induction was unique for all patients with 0.03 mg kg-1 midazolam, 0.5 mcg kg-1 fentanyl, 2 mg kg-1 propofol and 0.6 mg kg-1 rocuronium. Maintenance was achieved with sevoflurane of 1 minimum alveolar concentration in a mixture of 40% O2 and 60% N2O. As a component of multimodal analgesia, paracetamol (1 gr) was applied to all patients before skin incision.
Hemodynamic data were recorded throughout surgery. An increase more than 20% from baseline in mean arterial pressure (MAP) was defined as inadequate analgesia and was treated with bolus fentanyl (50 mcg). Hypotension was described with a decrease more than 20% in MAP and treated with ephedrine bolus. Bradycardia was determined with a heart rate (HR) less than 50 beats min-1 and treated with atropine. At the end of surgery, the patients were extubated in operating room.
Postoperative analgesia was achieved with IV morphine via Patient Controlled Analgesia (PCA) for 24 hours (0.01 mg kg-1 h-1 basal infusion, 1 mg bolus, 20 minutes lock-out time).
Postoperative follow-up included hemodynamic variables as well as pain scores and morphine consumption. Adequate analgesia at rest (static) and at moving of the arm interpreted as 45-90 degree abduction (dynamic) was investigated with Numeric Rating Scale (NRS) at 30th minute and 1st, 4th, 6th, 12th, 24th hours postoperatively. When NRS was 4 and higher, tramadol should be administered as rescue analgesic. In case of insufficient pain control at 30th minute, dermatomal analgesia should be assessed for both mid-axillary and midclavicular lines from T1 to T8 by pinprick test (0 there is sensation, 1 decreased sensation, 2 there is no sensation). Morphine consumption was evaluated at same study times.
Complications were determined as sedation assessed by Ramsey scale, postoperative nausea- vomiting (PONV) assessed with the four-point categorical scale (0=no PONV, 1=mild nausea, 2=severe nausea or vomiting once, and 3=vomiting more than once). Severe vomiting should be treated in a multimodal way and excluded from the study (category 2,3).
Staff anesthesiologist responsible for operative course did not contribute in analgesia assessment, nor in other postoperative follow-up. Other investigators who were blinded to operative management, collected postoperative data.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
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Istanbul, Peru, 34093
- Istanbul University, Istanbul Faculty of Medicine
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- unilateral MRM
- ages 18-75 years
- American Society of Anesthesiologists (ASA) classification I-III
Exclusion Criteria:
- presence of contraindications for using regional anesthesia (not having patient approval, presence of bleeding-clotting disorders, infection at the injection site, local anesthetic allergy)
- chronic analgesic use
- diabetes mellitus
- body mass index of (BMI) > 35 kg/m2.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Group P : TPVB
Thoracic paravertebral block
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20 ml 0.375 % bupivacaine was injected between superior costotransverse ligament and pleura.
20 ml 0.375 % bupivacaine was injected
|
Experimental: Group E : ESPB
Erector spinae plane block
|
20 ml 0.375 % bupivacaine was injected
20 ml 0.375 % bupivacaine was injected between deep fascia of the erector spinae muscle and transverse process.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Morphine consumption
Prazo: postoperative 24 hours
|
amount of postoperative 24 hours morphine consumption
|
postoperative 24 hours
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Static and dynamic pain score assessed with Numeric Rating Scale (NRS).
Prazo: postoperative 24 hours
|
Pain scores will be noted postoperative at 0, 30 minutes and 1,4,6,12,24 hours.
NRS=0 (minimum value, no pain).
NRS=10 (maximum value, worst pain imaginable).
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postoperative 24 hours
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intraoperative heart rate
Prazo: during surgery
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starting from induction to extubation (beat/min)
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during surgery
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intraoperative mean arterial pressure
Prazo: during surgery
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starting from induction to extubation (mmHg)
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during surgery
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nause and vomit
Prazo: postoperative 24 hours
|
Assessed with Postoperative Nause and Vomit (PONV) Scale.
(0=no PONV, 1=mild nausea, 2=severe nausea or vomiting once, and 3=vomiting more than once)
|
postoperative 24 hours
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number of blocked dermatome
Prazo: 30 minutes after block
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pinprick test in mid-axillar and mid-clavicular line
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30 minutes after block
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nükhet Sivrikoz, Attending anesthesiologist
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2018-1608
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