Ultrasound-Guided Rectus Sheath Block Versus Local Infiltration
Comparison of the Analgesic Effects of Local Anesthetic Infiltration and Ultrasound-Guided Rectus Sheath Block in Laparoscopic Cholecystectomy Operations: A Prospective Randomized Controlled Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Laparoscopic cholecystectomy is a very commonly performed and painful surgical procedure. The etiology of pain is complex and commonly includes pain related to trocar insertion sites, pain secondary to carbon dioxide insufflation, visceral pain, and shoulder pain. Various analgesic medications and regional anesthesia techniques are used for postoperative pain management. Abdominal wall blocks are frequently utilized to reduce opioid-related adverse effects.
Rectus sheath block is a regional anesthesia technique that blocks the anterior cutaneous branches of the lower thoracic nerves (T7-T12) and is used for analgesia in laparoscopic surgeries. Several studies have demonstrated that local anesthetic infiltration provides effective analgesia in laparoscopic cholecystectomy. Although rectus sheath block is an old technique traditionally used in midline surgeries, its analgesic use in laparoscopic procedures has increased in recent years.
In this prospective randomized clinical trial, we aimed to compare the effects of Local Anesthetic Infiltration and Rectus Sheath Block on opioid consumption and pain scores in laparoscopic gallbladder surgery.
To compare the effects of Local Anesthetic Infiltration and Rectus Sheath Block on opioid consumption and pain scores in laparoscopic gallbladder surgery.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: MUSTAFA ALTINAY
- Número de teléfono: 05333914422
- Correo electrónico: m_altinay@yahoo.com
Copia de seguridad de contactos de estudio
- Nombre: LEYLA KILINC
- Número de teléfono: +90 532 417 02 44
- Correo electrónico: leylaturkoglu@hotmail.com
Ubicaciones de estudio
-
-
-
Istanbul, Turquía (Türkiye), 34371
- Sisli Hamidiye Etfal Training Hospital
-
Contacto:
- MUSTAFA ALTINAY
- Número de teléfono: 05333914422
- Correo electrónico: m_altinay@yahoo.com
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- ASA (American Society of Anesthesiologists) class I-II patients
- Patients aged between 18 and 65 years
- Patients undergoing laparoscopic cholecystectomy surgery
Exclusion Criteria:
- ASA class III-IV patients
- Patients undergoing emergency surgery
- Relatives of patients who do not provide consent
- Presence of chronic pain
- Chronic opioid use
- Presence of local anesthetic allergy
- Ibuprofen allergy
- Paracetamol allergy
- Presence of infection at the block site
- Coagulopathy
- Increased intracranial pressure
- Pre-existing neurological deficit
- Severe organ failure
- Mental retardation
- Anatomical deformity
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 |
|---|---|
|
Comparador activo: GROUP RSB
Rectus Sheath Block: After completion of the operation, during the surgical closure phase, bilateral rectus sheath block will be performed. A linear ultrasound probe will be placed transversely over the umbilicus and 1 cm lateral to it. After visualization of the rectus abdominis muscle and posterior rectus sheath, a 22-Gauge 80 mm block needle (Braun Stimuplex Ultra-360, Melsungen, Germany) will be advanced from lateral to medial using the in-plane technique. Following hydrodissection with 1 mL saline between the rectus muscle and posterior sheath and confirmation of appropriate spread, 20 mL local anesthetic (0.25% bupivacaine) will be administered with intermittent negative aspiration. |
After completion of the operation, during the surgical closure phase, bilateral rectus sheath block will be performed.
A linear ultrasound probe will be placed transversely over the umbilicus and 1 cm lateral to it.
After visualization of the rectus abdominis muscle and posterior rectus sheath, a 22-Gauge 80 mm block needle (Braun Stimuplex Ultra-360, Melsungen, Germany) will be advanced from lateral to medial using the in-plane technique.
Following hydrodissection with 1 mL saline between the rectus muscle and posterior sheath and confirmation of appropriate spread, 20 mL local anesthetic (0.25% bupivacaine) will be administered with intermittent negative aspiration.
|
|
Comparador activo: GROUP LAI
Local Anesthetic Infiltration: At the end of the operation, the surgeon will infiltrate 5 mL local anesthetic (0.5% bupivacaine) subcutaneously into each of the four trocar insertion sites. |
At the end of the operation, the surgeon will infiltrate 5 mL local anesthetic (0.5% bupivacaine) subcutaneously into each of the four trocar insertion sites.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
NRS Score
Periodo de tiempo: Pain scores will be assessed and recorded at postoperative 0, 1, 4, 12, and 24 hours.
|
Postoperative pain assessment will be performed using the Numeric Rating Scale (NRS).
The NRS is a scale in which patients rate their pain intensity numerically from 0 (no pain) to 10 (worst imaginable pain).
|
Pain scores will be assessed and recorded at postoperative 0, 1, 4, 12, and 24 hours.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Opioid Consumption
Periodo de tiempo: 24 hour
|
Postoperative opioid consumption will be evaluated using intravenous patient-controlled analgesia (IV PCA) over 24 hours.
PCA will be set in bolus-only mode (10 mg tramadol), without continuous infusion.
Patients will be educated preoperatively regarding PCA use and instructed to administer boluses in case of pain.
At the end of 24 hours, total opioid consumption will be recorded from the device data, and the time to first bolus administration (time to first analgesic requirement) will also be evaluated.
|
24 hour
|
|
Adverse Effects
Periodo de tiempo: 24 hour
|
Adverse effects such as hypotension, bradycardia, nausea, vomiting, and local anesthetic systemic toxicity (LAST) occurring within the first 24 postoperative hours will be monitored and recorded.
|
24 hour
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: LEYLA KILINC, şişli etfal eğitim araştırma hastanesi
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
- zeynep-1
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .