Transversus Abdominis Plane Block From Abdominal Approach
Transversus Abdominis Plane Block From Intraabdominal Approach in Patients Undergoing Total Abdominal Hysterectomy: a Randomized Controlled Trial
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Wing Yee Lillian Choy, MBBS (HK)
- Número de teléfono: 3513 4245
- Correo electrónico: cwy027@ha.org.hk
Ubicaciones de estudio
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Kowloon
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Kwun Tong, Kowloon, Hong Kong
- Reclutamiento
- Department Of Anaesthesiology, Pain medicine and Operating Services. United Christian Hospital
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Contacto:
- Wing Yee Lillian Choy, MBBS (HK)
- Número de teléfono: 3513 4245
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Investigador principal:
- Wing Yee Lillian Choy, MBBS (HK)
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Sub-Investigador:
- Huey Sing Lim, FANZCA,FHKCA
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Sub-Investigador:
- Man Shun Law, FHKCA,FHKAM
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- ASA physical status I-III
- Age 18 or above
- Scheduled to undergo TAH+/- salpingoophorectomy.
- Scheduled to receive general anaesthesia under standardized anaesthetic regime.
- Comprehends how to use intravenous patient controlled analgesia (IV PCA).
- Is willing to complete the postoperative assessment.
- Understands the nature and purpose of this study and the study procedures and has signed the informed consent form for this study to indicate this understanding.
Exclusion Criteria:
- Known allergy to drugs involved in this study
- Previously taking medications thought to result in opioid tolerance, or analgesics thought to interfere with subsequent opioid requirement.
- Undergoing any procedures in addition to TAH+/- salpingoophorectomy.
- With co-existing pathology resulting in persistent pain requiring analgesics.
- Wound incision extending to supra-umbilical level.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 0.5% Ropivacaine
group receiving TAP block (0.5% ropivacaine at TAP plane)
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This intraabdominal approach to TAP block is being used regularly by gynaecological surgeons in this hospital now. To be performed bilaterally before surgical wound closure by an experienced surgeon who initially undergo initial observation by investigator to ensure uniformity in technique. Local anaesthetic or placebo solution will be injected to TAP with blunt needle from within abdominal cavity under visual and tactile guidance at the triangle of Petit, after feeling one 'pop' through the transversus abdominis muscle to the TAP layer. After careful aspiration to exclude vascular puncture, 1.5mg/kg of 0.5% ropivacaine or 0.3ml/kg of 0.9% saline placebo will be injected to each side slowly while observing for signs of toxicity.
Otros nombres:
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Comparador de placebos: normal saline
group receiving placebo (saline) at TAP plane
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This intraabdominal approach to TAP block is being used regularly by gynaecological surgeons in this hospital now. To be performed bilaterally before surgical wound closure by an experienced surgeon who initially undergo initial observation by investigator to ensure uniformity in technique. Local anaesthetic or placebo solution will be injected to TAP with blunt needle from within abdominal cavity under visual and tactile guidance at the triangle of Petit, after feeling one 'pop' through the transversus abdominis muscle to the TAP layer. After careful aspiration to exclude vascular puncture, 1.5mg/kg of 0.5% ropivacaine or 0.3ml/kg of 0.9% saline placebo will be injected to each side slowly while observing for signs of toxicity.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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postoperative 24hr morphine consumption
Periodo de tiempo: 24 hours
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The primary objective of this study is to demonstrate the effectiveness of tranversus abdominis plane block using the intraabdominal approach in reducing postoperative 24 hours morphine consumption after total abdominal hysterectomy (TAH) where time 0 is taken as time of arrival at PACU.
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24 hours
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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morphine consumption on arrival to post-anaesthetic care unit(PACU) and 4, 12 and 24 hours after.
Periodo de tiempo: 24hrs
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• Assess and compare the morphine consumption on arrival to post-anaesthetic care unit(PACU) and 4, 12 and 24 hours after.
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24hrs
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Degree on pain according to numerical pain score on arrival to post-anaesthetic care unit(PACU) and 4, 12 and 24 hours after during rest and movement (cough
Periodo de tiempo: 24hrs
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24hrs
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incidence of nausea and vomiting
Periodo de tiempo: 24hours postoperatively
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24hours postoperatively
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Wing Yee Lillian Choy, MBBS (HK), United Christian Hospital, Hospital Authority
Publicaciones y enlaces útiles
Publicaciones Generales
- McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f. Erratum In: Anesth Analg. 2007 May;104(5):1108.
- Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.
- Bonnet F, Berger J, Aveline C. Transversus abdominis plane block: what is its role in postoperative analgesia? Br J Anaesth. 2009 Oct;103(4):468-70. doi: 10.1093/bja/aep243. No abstract available.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- Protocol ver 1.1
- KC/KE-10-0021/FR-3 (Otro identificador: Research Ethics committee (Kowloon Central/Kowloon East))
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