Comparison of Intrathecal Morphine With the Quadratus Lumborum Type 2 Block for Post-operative Analgesia Following Elective Caesarean Section (QLBvITM Study)
Quadratus Lumborum Type 2 Block Versus Intrathecal Morphine for Analgesia Following Elective Caesarean Sections
Descripción general del estudio
Estado
Condiciones
Descripción detallada
In Australia the rate of birth via caesarean section (CS) has significantly increased over the last twenty years. Improvements in the care of women undergoing CS are important locally, nationally and internationally. Compared to women birthing vaginally, women undergoing CS experience more adverse events and more pain. Effective pain relief following CS is important as it enables early ambulation, encourages maternal bonding, and promotes breastfeeding initiation and establishment. Traditional analgesic techniques following CS include opioid medications. Whist effective, the use of opioids are associated with frequent and significant side effects. Alternative analgesic agents are being explored in an attempt to improve the effectiveness of pain relief available to women and clinicians.
The quadratus lumborum block (QLB) block is an innovative regional analgesic technique. Its role as an effective analgesic agent in abdominal surgery is increasing. However, it has not been studied for pain relief in Australia after cesarean section.
In this study, the investigator aims to compare post-operative analgesia and side effects between the QLB blocks versus adding morphine the participant's spinal anaesthetic (ITM) during the elective C/S. Results from this study will provide information on the analgesic impact of this new and emerging therapy and assist in the development of a larger clinical trial.
Tipo de estudio
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Anaesthetist trained in QLB and ITM techniques available
- American Society of Anaesthesiologists PS category client I or II
- 18 years of age or older
- Ability to read and understand English
- Uncomplicated pregnancy at term (>37 weeks completed gestation)
- Booked elective CS
Exclusion Criteria:
- Contraindications to spinal anaesthesia
- History of chronic opioid consumption / chronic pain conditions
- Known allergy to study drugs
- Weight more than 95kg or body mass index (BMI) more than 35 pre operative
- Placenta Previa / accreta
- Obstructive Sleep apnoea
- Severe asthma unable to tolerate Non steroidal anti inflammatory agents
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador falso: Saline intrathecal as well as saline in Blocks
These 25 patients will receive 0.3ml saline added to the spinal anaesthetic and 25 ml saline both sides as a QLB2.
|
0.3 ml saline will be added to the spinal anaesthetic.
25 ml saline will be used on each side during a quadratus lumborum type 2 block.
0.3 ml saline will be added to the spinal anaesthetic.
A Quadratus lumborum type 2 block will be performed under ultrasound with 25 ml 0.375% ropivacaine deposited posterior to the quadratus lumborum muscle.
|
|
Comparador activo: Saline intrathecal as well as local anaesthetic in Blocks
These 25 patients will receive 0.3ml saline added to the spinal anaesthetic and 25 ml local anaesthetic both sides as a QLB2.
|
0.3 ml saline will be added to the spinal anaesthetic.
25 ml saline will be used on each side during a quadratus lumborum type 2 block.
A Quadratus lumborum type 2 block will be performed under ultrasound with 25 ml 0.375% ropivacaine deposited posterior to the quadratus lumborum muscle.
150mcg morphine will be added to the spinal anaesthetic.
|
|
Comparador activo: Intrathecal morphine as well as local anaesthetic in Blocks
These 25 patients will receive 0.3ml (150mcg) morphine added to the spinal anaesthetic and 25 ml local anaesthetic both sides as a QLB2.
|
A Quadratus lumborum type 2 block will be performed under ultrasound with 25 ml 0.375% ropivacaine deposited posterior to the quadratus lumborum muscle.
150mcg morphine will be added to the spinal anaesthetic.
150mcg morphine will be added to the spinal anaesthetic.
25 ml saline will be used on each side during a quadratus lumborum type 2 block.
|
|
Comparador activo: Intrathecal morphine as well as saline in Block
These 25 patients will receive 0.3ml (150mcg) morphine added to the spinal anaesthetic and 25 ml saline both sides as a QLB2.
|
0.3 ml saline will be added to the spinal anaesthetic.
A Quadratus lumborum type 2 block will be performed under ultrasound with 25 ml 0.375% ropivacaine deposited posterior to the quadratus lumborum muscle.
150mcg morphine will be added to the spinal anaesthetic.
25 ml saline will be used on each side during a quadratus lumborum type 2 block.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
24 hours total intravenous morphine usage via a PCA pump
Periodo de tiempo: 24 hours
|
Post operative intravenous morphine use will be noted at 24 hours post cesarean section
|
24 hours
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Patient's side effects within the 24 hours post operative period.
Periodo de tiempo: 24 hours
|
Nausea, vomiting, itching, herpes reactivation, urinary retention and sedation will be noted.
|
24 hours
|
|
Pain Scores within 24 hours post operative period.
Periodo de tiempo: 24 hours
|
Using a VAS we will note both dynamic and static pain scores at 24 hours post operative
|
24 hours
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Willem Basson, FANZCA, Sunshine Coast University Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
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 (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
- HREC/17/QPCH/121
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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