ESP vs Subcostal TAP Block for Analgesia After Laparoscopic Cholecystectomy (ESP TAP)
Comparison Of Ultrasound-guided Erector Spinae Plane Block And Subcostal Transversus Abdominis Plane Block For Postoperative Analgesia In Laparoscopic Cholecystectomy: A Prospective Randomized Double-blind Multicenter Trial
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Postoperative pain remains a significant clinical concern after laparoscopic cholecystectomy despite the minimally invasive nature of the procedure. Inadequate analgesia may delay recovery, increase opioid consumption, and negatively affect patient satisfaction. Regional anesthesia techniques are increasingly incorporated into multimodal analgesia protocols to improve postoperative outcomes and reduce opioid requirements.
The erector spinae plane (ESP) block and the subcostal transversus abdominis plane (TAP) block are ultrasound-guided fascial plane blocks commonly used for abdominal surgery. While both techniques have demonstrated analgesic benefits, their comparative effectiveness in laparoscopic cholecystectomy remains uncertain. In particular, differences in visceral pain control, opioid-sparing effect, and shoulder pain incidence require further investigation.
This study is designed as a prospective, randomized, double-blind, parallel-group, clinical trial conducted at two tertiary care hospitals in Turkey. Eligible adult patients scheduled for elective laparoscopic cholecystectomy under general anesthesia will be randomly assigned to receive either bilateral ESP block or bilateral subcostal TAP block after induction of anesthesia. Standardized anesthesia and postoperative multimodal analgesia protocols will be applied in both groups to ensure comparability between centers.
The primary outcome measure is total opioid consumption within the first 24 postoperative hours, expressed as morphine equivalent dose. Secondary outcome measures include postoperative pain scores assessed using the Numerical Rating Scale (NRS), time to first analgesic request, incidence of shoulder pain, postoperative nausea and vomiting, and block-related complications.
Randomization will be performed using a computer-generated sequence, with allocation concealment ensured. Patients and postoperative outcome assessors will be blinded to group assignment. Data will be prospectively recorded and analyzed according to a predefined statistical analysis plan.
The findings of this study are expected to provide evidence-based guidance for optimizing regional analgesia strategies in laparoscopic cholecystectomy.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Bekir Suat Kürkçüoğlu
- Número de teléfono: 05055830463
- Correo electrónico: bekirsuat@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Bekir Suat Kürkçüoğlu
- Número de teléfono: +905055830463
- Correo electrónico: bekirsuat@gmail.com
Ubicaciones de estudio
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Gaziantep
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Şahinbey, Gaziantep, Turquía (Türkiye), 27060
- Gaziantep City Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Adults aged 18 years and older
Scheduled for elective laparoscopic cholecystectomy under general anesthesia
American Society of Anesthesiologists (ASA) physical status I-III
Ability to understand the study protocol and provide written informed consent -
Exclusion Criteria:Refusal to participate
Known allergy or contraindication to local anesthetic agents
Coagulopathy or anticoagulant therapy contraindicating regional anesthesia
Infection at the planned injection site
Body mass index (BMI) > 35 kg/m²
Chronic opioid use or opioid dependence
Chronic pain syndromes requiring regular analgesic treatment
Severe hepatic, renal, or cardiac dysfunction
Pregnancy or breastfeeding
Inability to communicate or assess pain using the Numerical Rating Scale (NRS)
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Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Erector Spinae Plane Block
Patients in this arm will receive ultrasound-guided bilateral erector spinae plane block following induction of general anesthesia.
A standardized volume and concentration of local anesthetic will be administered at the appropriate thoracic level.
All patients will receive standardized intraoperative anesthesia and postoperative multimodal analgesia.
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Ultrasound-guided bilateral erector spinae plane block will be performed after induction of general anesthesia.
The block will be administered at the appropriate thoracic vertebral level using a standardized volume and concentration of local anesthetic deposited in the fascial plane deep to the erector spinae muscle.
The procedure will be performed by experienced anesthesiologists under sterile conditions.
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Experimental: Subcostal TAP Block
Patients in this arm will receive ultrasound-guided bilateral subcostal transversus abdominis plane block following induction of general anesthesia.
A standardized volume and concentration of local anesthetic will be administered.
All patients will receive standardized intraoperative anesthesia and postoperative multimodal analgesia.
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Ultrasound-guided bilateral subcostal transversus abdominis plane block will be performed after induction of general anesthesia.
A standardized volume and concentration of local anesthetic will be injected into the fascial plane between the rectus abdominis and transversus abdominis muscles along the subcostal margin.
The procedure will be performed by experienced anesthesiologists under sterile conditions.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Total Opioid Consumption in the First 24 Hours Postoperatively
Periodo de tiempo: Within 24 hours after surgery
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Total opioid consumption during the first 24 postoperative hours, converted to intravenous morphine equivalent dose (mg), recorded from patient-controlled analgesia devices and supplemental opioid administration.
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Within 24 hours after surgery
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Bekir Suat Kurkcuoglu, Gaziantep City Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- This study will generate individual participant data (IPD) related to postoperative analgesia, including opioid consumption, pain scores, and block-related complications. Data will be de-identified prior to sharing. Access to IPD will be available upon reasonable request to the corresponding author after publication of the main study results. Data requests will require a signed data use agreement, specifying the purpose of analysis and acknowledgment of original investigators. Supporting documentation, including study protocol and statistical analysis plan, will also be provided to researchers granted access.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BS-ESP-TAP-2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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