- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07720817
Ultrasound Guided Retrolaminar Block Versus Transverse Abdominis Plane Block in Laparoscopic Upper Abdominal Surgeries
Safety and Efficacy of Ultrasound Guided Retrolaminar Block Versus Transverse Abdominis Plane Block on Quality of Recovery in Laparoscopic Upper Abdominal Surgeries: A Randomized Comparative Clinical Trial
Descripción general del estudio
Estado
Descripción detallada
Laparoscopic surgery is now a widely accepted practice, offering several advantages, including better cosmetic outcomes, increased patient satisfaction, and shorter hospital stays . The complexity and range of procedures performed laparoscopically have grown significantly, now including complex operations like cholecystectomy, nephrectomy, hernia repair, and an increasing number of emergency surgeries .
Despite these benefits, postoperative pain following laparoscopic procedures, such as cholecystectomy, can be substantial and hinder recovery . This pain may negatively affect respiratory function, delay ambulation, and ultimately prolong their hospital stay. Historically, pain management has often relied on high doses of narcotics, which may lead to complications like dizziness, respiratory depression, and postoperative nausea and vomiting (PONV) . These drawbacks have spurred the search for alternative and improved pain relief strategies .
Ultrasound-guided nerve blocks have become an essential component of multimodal postoperative analgesia due to their effectiveness, precision, and safety profile . One of such techniques is the Transversus Abdominis Plane (TAP) block, which is used as part of a comprehensive strategy to optimize postoperative pain control. Local anesthetic is injected into the neurovascular plane of the abdominal wall . The TAP block works by providing sensory blockade to the spinal nerves that run between the internal oblique and transverse abdominis muscles. The anesthetic infiltration affects the thoracic intercostal nerves, the ilioinguinal and iliohypogastric nerves, and the lateral cutaneous branches of the lumbar nerves.
Another important technique is the Retrolaminar Block (RLB), introduced in 2006 as a simpler alternative to the thoracic paravertebral block (TPVB) . The RLB is less invasive because it targets the bony vertebral lamina, unlike the TPVB, which requires puncturing the superior costotransverse ligament . The procedure involves injecting a local anesthetic (LA) into the fascial plane located between the posterior thoracic lamina and the overlying transversus spinae muscles allowing spread of the local anesthetic to the thoracic paravertebral and epidural spaces, thus the blockade of the dorsal branch of the spinal nerves that cross the retrolaminar plane .Studies, including cadaveric models, have confirmed that the anesthetic injected during an RLB spreads through the intertransverse ligaments into the paravertebral and epidural spaces, effectively numbing 2-4 spinal segments . For instance, a 2022 clinical trial showed that ultrasound-guided RLBs significantly reduced opioid consumption in patients recovering from laparoscopic cholecystectomy compared to conventional pain management , highlighting its potential as a safe and effective option.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: mohamed elnagar Mohamed A. Elnagar MB BCh, MB BCh
- Número de teléfono: +20 1009344804
- Correo electrónico: melnaggar789@gmail.com
Ubicaciones de estudio
-
-
Dakahlia Governorate
-
Al Mansurah, Dakahlia Governorate, Egipto
- Reclutamiento
- Mansoura University
-
Contacto:
- mohamed a Mohamed A. Elnagar MB BCh, MB BCh
- Número de teléfono: +20 1009344804
- Correo electrónico: melnaggar789@gmail.com
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age between 21 and 65 years.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Body mass index (BMI) less than 30 kg/m².
- Scheduled for elective laparoscopic upper abdominal surgery under general anesthesia.
Exclusion Criteria:
- Refusal to participate in the study.
- Known allergy or hypersensitivity to any of the study drugs.
- Infection at the planned block insertion site.
- Severe uncontrolled cardiac, renal, hepatic, neurological, or respiratory disease.
- Pre-existing chronic pain.
- Immunodeficiency.
- Coagulation abnormalities, anticoagulant therapy, or platelet count less than 80,000/µL.
- Emergency surgery.
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 |
|---|---|
|
Experimental: Retrolaminar Block Group
Patients will receive an ultrasound-guided retrolaminar block using 20 ml of 0.25% of bupivacaine administered at the T7 level at both sides
|
Ultrasound-guided bilateral retrolaminar block performed before surgery using the study local anesthetic.
|
|
Comparador activo: Transverses Abdominis Plane (TAP) Block Group
Patients will receive an ultrasound-guided TAP block using 20 ml of 0.25% bupivacaine at both sids
|
Ultrasound-guided bilateral transversus abdominis plane (TAP) block performed before surgery using the study local anesthetic.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The postoperative Quality of Recovery-15 score
Periodo de tiempo: 24 hour postoperative
|
The Quality of Recovery-15 (QoR-15) questionnaire consists of 15 items.
The total score ranges from 0 to 150, with higher scores indicating better postoperative recovery.
|
24 hour postoperative
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Numeric Rating Scale (NRS) at rest and during coughing
Periodo de tiempo: Immediately after arrival in the post-anesthesia care unit (0 hours), and at 2, 4, 6, 12, and 24 hours after surgery.
|
Postoperative pain intensity at rest and during coughing will be assessed using the Numeric Rating Scale (NRS).
The NRS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain .
Higher scores indicate greater pain intensity (worse outcome).
|
Immediately after arrival in the post-anesthesia care unit (0 hours), and at 2, 4, 6, 12, and 24 hours after surgery.
|
|
Total dose of rescue analgesics administered (mg) within the first 24 hours after surgery
Periodo de tiempo: From the end of surgery to 24 hours after surgery.
|
The cumulative dose of rescue postoperative analgesics administered to each participant during the first 24 hours after surgery will be recorded.
Higher values indicate greater postoperative analgesic requirements.
|
From the end of surgery to 24 hours after surgery.
|
|
Time to first postoperative opioid analgesic request (hours)
Periodo de tiempo: From the end of surgery until the first request for opioid analgesia, up to 24 hours postoperatively
|
Time from the end of surgery until the first postoperative request for opioid analgesia
|
From the end of surgery until the first request for opioid analgesia, up to 24 hours postoperatively
|
|
Duration of hospital stay
Periodo de tiempo: From the date of surgery until hospital discharge, assessed for up to 30 days after surgery
|
Duration of hospital stay, measured as the number of days from the date of surgery until hospital discharge.
|
From the date of surgery until hospital discharge, assessed for up to 30 days after surgery
|
|
Mean intraoperative mean arterial pressure (mmHg)
Periodo de tiempo: At baseline (before block), immediately after block (0 minutes), at 5, 10, 20, 30, 60, 90, and 120 minutes after block , or until the end of surgery, whichever occurs first.
|
Mean arterial pressure (MAP), measured in millimeters of mercury (mmHg), will be recorded during surgery
|
At baseline (before block), immediately after block (0 minutes), at 5, 10, 20, 30, 60, 90, and 120 minutes after block , or until the end of surgery, whichever occurs first.
|
|
Mean intraoperative heart rate (beats/min)
Periodo de tiempo: At baseline (before block), immediately after block (0 minutes), at 5, 10, 20, 30, 60, 90, and 120 minutes after block , or until the end of surgery, whichever occurs first.
|
Heart rate (HR), measured in beats per minute (beats/min), will be recorded during surgery
|
At baseline (before block), immediately after block (0 minutes), at 5, 10, 20, 30, 60, 90, and 120 minutes after block , or until the end of surgery, whichever occurs first.
|
|
Mean intraoperative peripheral oxygen saturation (%)
Periodo de tiempo: At baseline (before block), immediately after block (0 minutes), at 5, 10, 20, 30, 60, 90, and 120 minutes after block , or until the end of surgery, whichever occurs first.
|
Peripheral oxygen saturation (SpO₂), measured as percentage (%), will be recorded during surgery
|
At baseline (before block), immediately after block (0 minutes), at 5, 10, 20, 30, 60, 90, and 120 minutes after block , or until the end of surgery, whichever occurs first.
|
|
Number of participants with postoperative nausea
Periodo de tiempo: From the end of surgery to 24 hours after surgery
|
Number of participants who experienced postoperative nausea
|
From the end of surgery to 24 hours after surgery
|
|
Number of participants with postoperative vomiting
Periodo de tiempo: From the end of surgery to 24 hours after surgery
|
Number of participants who experienced postoperative vomiting
|
From the end of surgery to 24 hours after surgery
|
|
Number of participants with postoperative shivering
Periodo de tiempo: From the end of surgery to 24 hours after surgery
|
Number of participants who experienced postoperative shivering
|
From the end of surgery to 24 hours after surgery
|
|
Number of participants with postoperative hypotension
Periodo de tiempo: From the end of surgery to 24 hours after surgery
|
Number of participants who experienced postoperative hypotension
|
From the end of surgery to 24 hours after surgery
|
|
Number of participants with postoperative bradycardia
Periodo de tiempo: From the end of surgery to 24 hours after surgery
|
Number of participants who experienced postoperative bradycardia
|
From the end of surgery to 24 hours after surgery
|
|
Number of participants with postoperative headache
Periodo de tiempo: From the end of surgery to 24 hours after surgery
|
Number of participants who experienced postoperative headache
|
From the end of surgery to 24 hours after surgery
|
|
Total intraoperative ephedrine dose administered (mg)
Periodo de tiempo: From induction of anesthesia until the end of surgery
|
The cumulative dose of ephedrine administered intraoperatively for the treatment of hypotension, measured in milligrams (mg).
|
From induction of anesthesia until the end of surgery
|
|
Number of participants requiring intraoperative ephedrine administration
Periodo de tiempo: From induction of anesthesia until the end of surgery
|
Number of participants who required ephedrine administration for the treatment of intraoperative hypotension.
|
From induction of anesthesia until the end of surgery
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: hatem saber mohamed ali, Professor, Faculty of Medicine, Mansoura University
- Silla de estudio: Naglaa A Elnegeery, Associate Professor, Faculty of Medicine, Mansoura University
- Director de estudio: Ola Shawky Naguib El Nagar, Lecturer, Faculty of Medicine, Mansoura University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Otros números de identificación del estudio
- Retrolamianr and TAP blocks
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.
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. .