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- Ensaio Clínico NCT07930078
Erector Spinae Plane Block Versus Subcostal Transversus Abdominis Plane Block Under Skin Conductance Algesimeter Guidance in Laparoscopic Gynecologic Oncologic Surgery
Comparison of the Analgesic Efficacy of Bilateral Subcostal Transversus Abdominis Plane Block and Bilateral Erector Spinae Plane Block Guided by Skin Conductance Algesimeter Pain Monitoring in Laparoscopic Gynecologic Oncologic Surgery: A Prospective Randomized Study
This prospective randomized study compared two ultrasound-guided regional anesthesia techniques used as part of multimodal analgesia in women undergoing elective laparoscopic gynecologic oncologic surgery: bilateral erector spinae plane (ESP) block and bilateral subcostal transversus abdominis plane (TAP) block. During general anesthesia, the remifentanil infusion was titrated according to the skin conductance algesimeter (SCA), a device that monitors the sympathetic response to noxious stimuli. The main question was whether ESP block reduces intraoperative remifentanil consumption compared with subcostal TAP block. Postoperative pain scores, rescue analgesic requirement, and quality of recovery were also compared during the first 24 postoperative hours.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Female patients aged 18-65 years with ASA physical status I-III scheduled for elective laparoscopic gynecologic oncologic surgery were randomized in a 1:1 ratio using a computer-generated list (Research Randomizer) to the ESP group or the subcostal TAP group. General anesthesia was induced with fentanyl 0.5 µg/kg, propofol 2.5 mg/kg, and rocuronium 0.6 mg/kg and maintained with sevoflurane at approximately 1 minimum alveolar concentration. After induction and before surgical incision, blocks were performed under ultrasound guidance by experienced anesthesiologists with 20 mL of 0.25% bupivacaine on each side (total 40 mL): bilateral ESP block at the T9 level in the lateral decubitus position, or bilateral subcostal TAP block at the midclavicular line below the costal margin in the supine position.
Remifentanil infusion was started at 0.05-0.2 µg/kg/min and titrated according to the SCA index: decreased by 0.025 µg/kg/min when the index was 0-1, maintained when it was 3, and increased by 0.025-0.05 µg/kg/min when it was above 3, with at least 5 minutes between dose changes. The infusion could be reduced to zero when the SCA index remained at 0-1. Heart rate, blood pressure, SCA index, and bispectral index (BIS) were recorded at baseline, after intubation, every 15 minutes during surgery, and before and after extubation. All patients received intravenous dexketoprofen 50 mg and paracetamol 1 g approximately 30 minutes before the end of surgery.
Postoperative pain was assessed with the Numeric Rating Scale (NRS) at 0, 2, 4, 6, 12, 18, and 24 hours. Tenoxicam was given for NRS ≥4 and tramadol for NRS ≥7 as rescue analgesics. The Quality of Recovery-15 (QoR-15) questionnaire was administered preoperatively and at 24 hours postoperatively. Intraoperative data and postoperative follow-up were recorded by investigators who did not perform the blocks.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Savaş Altınsoy
- Número de telefone: 05332257104
- E-mail: savasaltinsoy@gmail.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
Women aged 18-65 years Scheduled for elective laparoscopic gynecologic oncologic surgery ASA physical status I-III Body mass index 18-40 kg/m² Written informed consent No contraindication to regional block
Exclusion Criteria:
Age <18 or >65 years ASA physical status IV or higher Severe systemic comorbidity Known allergy to local anesthetics Bleeding diathesis or coagulopathy Infection at the block site Body mass index <18 or >40 kg/m² Emergency surgery
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 |
|---|---|
|
Outro: ESP Group
Bilateral ultrasound-guided erector spinae plane block at the T9 level with 20 mL of 0.25% bupivacaine on each side, performed after induction of general anesthesia and before surgical incision. Intraoperative remifentanil infusion titrated according to the skin conductance algesimeter index. |
Procedure: Erector spinae plane block - Ultrasound-guided bilateral ESP block at T9 with 20 mL of 0.25% bupivacaine per side. Arm: ESP Group. |
|
Outro: Subcostal TAP Group
Bilateral ultrasound-guided subcostal transversus abdominis plane block with 20 mL of 0.25% bupivacaine on each side, performed after induction of general anesthesia and before surgical incision. Intraoperative remifentanil infusion titrated according to the skin conductance algesimeter index. |
Procedure: Subcostal transversus abdominis plane block - Ultrasound-guided bilateral subcostal TAP block at the midclavicular line with 20 mL of 0.25% bupivacaine per side. Arm: Subcostal TAP Group. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Total intraoperative remifentanil consumption
Prazo: from induction of anesthesia to the end of surgery.
|
Total intraoperative remifentanil consumption - Total amount of remifentanil (µg) administered under skin conductance algesimeter guidance. |
from induction of anesthesia to the end of surgery.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Time to first rescue analgesic
Prazo: 0, 2, 4, 6, 12, 18, and 24 hours postoperatively.
|
Time to first rescue analgesic - Time from extubation to the first rescue analgesic administration (minutes). Time frame: first 24 postoperative hours. |
0, 2, 4, 6, 12, 18, and 24 hours postoperatively.
|
|
Rescue analgesic requirement
Prazo: 0, 2, 4, 6, 12, 18, and 24 hours postoperatively.
|
Rescue analgesic requirement - Number of patients receiving rescue analgesics (tenoxicam or tramadol). 0, 2, 4, 6, 12, 18, and 24 hours postoperatively. |
0, 2, 4, 6, 12, 18, and 24 hours postoperatively.
|
|
Postoperative pain scores
Prazo: 0, 2, 4, 6, 12, 18, and 24 hours postoperatively.
|
Postoperative pain scores - Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain). |
0, 2, 4, 6, 12, 18, and 24 hours postoperatively.
|
|
Quality of recovery
Prazo: Time frame: preoperatively and 24 hours postoperatively.
|
Quality of recovery - Quality of Recovery-15 (QoR-15) score (0-150; higher scores indicate better recovery). |
Time frame: preoperatively and 24 hours postoperatively.
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: Savaş Altınsoy, Ankara Etlik City Hospital
Publicações e links úteis
Publicações Gerais
- Tsai HC, Yoshida T, Chuang TY, Yang SF, Chang CC, Yao HY, Tai YT, Lin JA, Chen KY. Transversus Abdominis Plane Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:8284363. doi: 10.1155/2017/8284363. Epub 2017 Oct 31.
- Oraee S, Rajai Firouzabadi S, Mohammadi I, Alinejadfard M, Golsorkh H, Hatami S. Erector spinae plane block for laparoscopic surgeries: a systematic review and meta-analysis. BMC Anesthesiol. 2024 Oct 29;24(1):389. doi: 10.1186/s12871-024-02775-4.
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
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças Genitais
- Dor
- Manifestações Neurológicas
- Complicações pós-operatórias
- Processos Patológicos
- Neoplasias urogenitais
- Neoplasias por local
- Neoplasias
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Doenças Genitais Femininas
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Dor, Pós-operatório
- Neoplasias Genitais Femininas
Outros números de identificação do estudo
- Furkan Hökelekli Tez
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