Lumbar Paravertebral in Hernia Surgery
Comparison Between Lumbar Paravertebral and Field Blocks in Pediatric Inguinal Hernia Surgery.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Different anesthetic regional techniques can be used for anesthesia and analgesia of the lower abdominal surgeries such as caudal, spinal, epidural, transversus abdominis plane block, ilioinguinal nerve block, lumbar plexus block, the field block and abdominal paravertebral block. The use of regional anesthesia with ultrasound guidance can help decrease complications of regional blocks.
In the lumbar area, the lumbar paravertebral space is a potential space formed by the vertebral bodies, intervertebral discs and intervertebral foramina medially, the psoas major muscle anterolaterally and the erector spinae muscles, the transverse process and intertransverse ligaments posteriorly. There is no costotransverse ligament in the lumbar region. The lumbar spinal nerve roots run through the paravertebral space then continue through the psoas major muscle where they form the lumbar plexus.The spinal nerves in this space are devoid of a fascial sheath making them exceptionally susceptible to local anesthetics. The diaphragm and psoas muscle separate the thoracic and lumbar paravertebral areas; however, communication may occur via the medial and lateral arcuate ligaments of the diaphragm.
Field block can be done by subcutaneous injection of a local anesthetic in an area bordering on the field to be anesthetized. It is safe, simple, effective, and economical, without post anesthesia side effects. Furthermore, local anesthesia administered before the incision produces longer postoperative analgesia because of local infiltration, theoretically, inhibits the build-up of local nociceptive molecules, and therefore, there is better pain control in the postoperative period.
The aim of this study is to compare the analgesic and autonomic effects of unilateral abdominal ultrasound guided paravertebral block with field block in pediatric inguinal hernia surgery.
This study hypothesizes that unilateral abdominal ultrasound guided paravertebral block may be more superior to field block in reducing intra and postoperative pain in the pediatric inguinal hernia. The analgesic efficacy and duration of ultrasound (US) guided unilateral lumbar paravertebral block and field block were compared when dexmedetomidine and epinephrine were added as adjuvants to bupivacaine.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Dakahlia
-
Mansoura, Dakahlia, Egipto, 35516
- Mansoura University Children's Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients subjected to an elective unilateral inguinal hernia repair.
- American Society for Anesthesiologists physical status grades I and II.
Exclusion Criteria:
1. Parental refusal. 2. Neuromuscular diseases (as myopathies, myasthenia gravies, etc.) 3. Hematological diseases, bleeding or coagulation abnormality. 4. Psychiatric diseases. 5. Local skin infection and sepsis at the site of the block. 6. Known intolerance to the study drugs.
-
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Lumbar paravertebral group
After general anesthesia, the patient is placed prone.
To establish the level of the block, we used US-counting of vertebrae.
After determining the lumbar one level, the block performed at a parallel line 2 cm lateral to the spinous process, the transducer is moved until the corresponding transverse process is identified.
Utilizing an in-plane approach from lateral to medial, a spinal needle is advanced until contact with the transverse process.
The needle is withdrawn and redirected caudally under the transverse process helped by the loss of resistance technique.
the solution is slowly injected after negative aspiration for blood.
|
A mixture of 0.5 ml /kg bupivacaine (0.25%), and 0.5µg/Kg dexmedetomidine and Epinephrine 5 microgram/ ml.
|
|
Comparador activo: The field block group
The ilioinguinal nerve block was done at one fingerbreadth from the anterior superior iliac spine in a line with the pubic tubercle, The injection was done after the bob of the needle after passing the external oblique aponeurosis and muscle and 5ml of the solution is injected.
The rest of the solution is injected in the incision line.
|
A mixture of 0.5 ml /kg bupivacaine (0.25%), and 0.5µg/Kg dexmedetomidine and Epinephrine 5 microgram/ ml.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The total dose of analgesics required in the post-operative periods
Periodo de tiempo: 24 hours postoperatively
|
Fentanyl in microgram.
|
24 hours postoperatively
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Modified Faces Legs Activity Cry Consolability Revised pain Scale
Periodo de tiempo: postoperative at 1, 2, 4, 8,16, 24 hours.
|
pain score of 5 items (Faces, Legs, Activity, Cry, Consolability) each of 0, 1, or 2 points.
0= express no pain, 1= mild pain, 2= the highest pain indicator.
A total score 0 = Relaxed and comfortable.
1-3 = Mild discomfort.
4-6 = Moderate pain.
7-10 = Severe pain.
|
postoperative at 1, 2, 4, 8,16, 24 hours.
|
|
Mean Blood pressure
Periodo de tiempo: Basal preoperative, during incision, 30 minutes, 60 minutes intraoperatively, postoperative at 1, 2, 4, 8,16, 24 hours.
|
millimeter mercury
|
Basal preoperative, during incision, 30 minutes, 60 minutes intraoperatively, postoperative at 1, 2, 4, 8,16, 24 hours.
|
|
Heart rate
Periodo de tiempo: Basal preoperative, during incision, 30 minutes, 60 minutes intraoperatively, postoperative at 1, 2, 4, 8,16, 24 hours.
|
beat/minutes
|
Basal preoperative, during incision, 30 minutes, 60 minutes intraoperatively, postoperative at 1, 2, 4, 8,16, 24 hours.
|
|
Modified Ramsay sedation scale.
Periodo de tiempo: postoperative at 2, 4, 6, 12, 16, 24 hours.
|
a scale from (1- 6), 1 = anxious; 2 = oriented & tranquil; 3 = sedated, but responds to commands; 4 = asleep, brisk glabellar reflex or response to loud noise; 5 = asleep, slugglish glabellar reflex or response to loud noise; 6 = asleep with no response to painful stimulus
|
postoperative at 2, 4, 6, 12, 16, 24 hours.
|
|
Parents' satisfaction score
Periodo de tiempo: postoperative after 24 hours.
|
in a visual analogue score from (0-10), 0= minimal satisfaction, 10 = the highest satisfaction.
|
postoperative after 24 hours.
|
|
Adverse effects including nausea and vomiting, bradycardia (heart rate less than 60 beat/minute)
Periodo de tiempo: postoperatively in the first 24 hours.
|
percent
|
postoperatively in the first 24 hours.
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MS/16.06.19
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- SAVIA
- RSC
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. .
Ensayos clínicos sobre Lumbar paravertebral group
-
Shanghai Jiao Tong University Affiliated Sixth...Desconocido
-
Saglik Bilimleri UniversitesiAún no reclutandoEfecto de la reflexología en los síntomas del síndrome premenstrual
-
Tongji HospitalReclutamientoNeumotórax | Síndrome de Dificultad Respiratoria Aguda (SDRA) | Atelectasia | Cirugía toracoscópica asistida por video (VATS) | Broncoespasmo | Cáncer de pulmón (diagnóstico) | Infecciones Pulmonares | Fístula broncopleural | Derrame pleural debido a otro trastorno (trastorno) | Embolia pulmonar (diagnóstico) y otras condicionesPorcelana
-
Ondokuz Mayıs UniversityTerminadoAnalgesia | Dolor agudo | Anestesia | Analgesia controlada por el pacientePavo
-
University of LisbonAssociacao Protectora dos Diabeticos de PortugalTerminado
-
Arizona Oncology ServicesDesconocidoCáncer de mama localizado | Cáncer de próstata localizado | Pacientes que reciben radioterapia de haz externoEstados Unidos
-
Tarsus UniversityReclutamiento
-
University of TennesseeNational Cancer Institute (NCI)Activo, no reclutandoPérdida de peso | Sobrepeso y Obesidad | Comportamiento, SaludEstados Unidos
-
Kutahya Health Sciences UniversityScientific Research Projects Coordination UnitReclutamientoContacto piel con pielTurquía (Türkiye)