Erector Spinae Plane Block Versus Subcostal Transversus Abdominis Plane Block Under Skin Conductance Algesimeter Guidance in Laparoscopic Gynecologic Oncologic Surgery
Postoperative Pain · Gynecologic Neoplasms
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - 65 años
- Sexo admitido
- Femenino
- Voluntarios sanos
- No aceptados
- Participantes
- 66 Estimado
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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
Leer la descripción completa
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.
¿Quién podría participar?
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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
Entiende la evaluación inicialTratamiento, grupos y participación
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- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento simple
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.
Other: Erector spinae plane block
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.
Other: Subcostal transversus abdominis plane block
Erector spinae plane block OTHER
Procedure: Erector spinae plane block - Ultrasound-guided bilateral ESP block at T9 with 20 mL of 0.25% bupivacaine per side. Arm: ESP Group.
Subcostal transversus abdominis plane block OTHER
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.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Total intraoperative remifentanil consumption
Plazo: from induction of anesthesia to the end of surgery.
Total intraoperative remifentanil consumption - Total amount of remifentanil (µg) administered under skin conductance algesimeter guidance.
Medidas secundarias
Time to first rescue analgesic
Plazo: 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.
Rescue analgesic requirement
Plazo: 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.
Postoperative pain scores
Plazo: 0, 2, 4, 6, 12, 18, and 24 hours postoperatively.
Postoperative pain scores - Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain).
Quality of recovery
Plazo: Time frame: preoperatively and 24 hours postoperatively.
Quality of recovery - Quality of Recovery-15 (QoR-15) score (0-150; higher scores indicate better recovery).
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (0)
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No hay centros indicados. Usa el contacto oficial del estudio.
Equipo y fechas
- Patrocinador principal
- Diskapi Yildirim Beyazit Education and Research Hospital
- Inicio del estudio
- 15 nov 2026 Estimado
- Finalización primaria
- 15 feb 2027 Estimado
- Finalización del estudio
- 15 mar 2027 Estimado
- Primera publicación
- 10 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
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
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026
