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
Visão geral do estudo
Status
Condições
Descrição detalhada
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 estudo
Estágio
- Não aplicável
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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 Ativo: 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 Ativo: 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 Ativo: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
24 hours total intravenous morphine usage via a PCA pump
Prazo: 24 hours
|
Post operative intravenous morphine use will be noted at 24 hours post cesarean section
|
24 hours
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Patient's side effects within the 24 hours post operative period.
Prazo: 24 hours
|
Nausea, vomiting, itching, herpes reactivation, urinary retention and sedation will be noted.
|
24 hours
|
|
Pain Scores within 24 hours post operative period.
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Antecipado)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- HREC/17/QPCH/121
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