Study of QL Analgesic Response and Extent (SQUARE)
7 de julho de 2026 atualizado por: Duke University
Anterior Versus Posterior Versus Lateral Quadratus Lumborum Block: a Randomized Control Trial in Healthy Volunteers
A total of 14-18 healthy volunteers will be included.
There will be three different procedure days, separated by at least one week.
On each visit, the subjects will receive a QL block, according to the randomization process.
Each volunteer will undergo pre-procedure screening on the first visit.
The blocks will be performed on the same side, by the same anesthesiologist, with at least one week between each block.
An anterior QL block will be administered on one day, a posterior QL block on another, and a lateral QL block on the third.
The order will be randomized, and both the subject and the research team member assessing the block will be blinded.
To compare the dermatomal sensory block distribution, the investigators will use detailed mapping with pinprick, cold, and heat stimuli.
A handheld dynamometric assessment of lower extremity strength.
The testing will be performed 60 to 90 minutes after performance of the blocks.
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Descrição detalhada
Regional anesthesia techniques are widely employed to achieve sensory blockade of the abdominal wall. Among these, the epidural remains the most well-established approach, offering bilateral spread. However, its association with neuraxial complications has led to a decline in its clinical use. In contrast, fascial plane blocks, avoid neuraxial-related risks. The advent of ultrasound-guided blocks has sparked growing interest in novel fascial plane blocks, that can deliver multi-dermatomal with a lower rate of complications.
Three Quadratus Lumborum (QL) blocks are an example of these fascial plane blocks, commonly performed for abdominal and pelvic surgery. Despite their widespread clinical use, no prior studies have directly compared the three techniques in terms of their cutaneous distribution. Additionally, case reports note that lower extremity weakness can sometimes temporarily occur as a result of accidental spread to the lumbar plexus. Thus, this randomized, double-blinded trial aims to investigate the cutaneous distribution of these three blocks in healthy adult volunteers. Lastly, this study will assess the incidence and severity of lower extremity weakness that may occur with each technique. In addition, this study also seeks to investigate the pharmacokinetics (PK) of lidocaine in each technique. The rationale for this lies in the anatomical differences between the blocks. Theoretically, there may be a difference in the anatomical target for these blocks, but the investigators hypothesize that there is no difference in the local anesthetic absorption. Therefore, as the investigators expect similar systemic absorption, the chances of local anesthetic systemic toxicity (LAST) should be equally low, and all blocks should be similarly safe.
Tipo de estudo
Intervencional
Inscrição (Estimado)
25
Estágio
- Fase 4
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Brian Mendelson, MD
- Número de telefone: 818-456-7040
- E-mail: brian.mendelson@duke.edu
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
Inclusion Criteria:
- Ability to provide written informed consent
- Ability and willingness to comply with the study procedures and duration requirements
- ASA physical status 1 or 2
- Age ≥ 18 years
- Weight > 70kg
Exclusion Criteria:
- BMI > 35kg.m2
- Use of analgesics within 24 hours before the procedure
- History of thoracic trauma or surgery
- Abdominal deformities or abnormalities that may prevent proper block performance
- Abdominal tattoos in the area of block performance
- Systemic neuromuscular disease
- Contraindications to regional anesthesia (e.g., infection, allergy, challenging sonoanatomy)
- Structures are unable to be visualized by ultrasound
- Pregnancy
- Other known health conditions that would affect the participant's ability to successfully complete the study
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Lateral Quadratus Lumborum block
Participants receive quadratus lumborum block under ultrasound guidance, with 30mL of 1.5% lidocaine on one visit.
|
For the anterior QL block, a curvilinear probe and nerve stimulator will be used.
Local anesthetic will be deposited anterior to the QL muscle but posterior to the psoas muscle.
A nerve stimulator at 2 Hz frequency, 1.5 mA will be used to aid in identification of intramuscular placement of the needle.
Local anesthetic will only be deposited if no twitch is seen in either the QL or psoas muscle with an appropriate circuit formed.
For the posterior QL block, a linear or curvilinear probe will be used, at the discretion of the anesthesiologist.
Local anesthetic will be deposited posterior to the QL muscle such that anterior depression of the muscle is seen.
For the lateral QL block, local anesthetic will be deposited lateral to the QL muscle.
|
|
Experimental: Anterior Quadratus Lumborum Block
Participants receive anterior quadratus lumborum block under ultrasound guidance, with 30mL of 1.5% lidocaine on one visit.
|
For the anterior QL block, a curvilinear probe and nerve stimulator will be used.
Local anesthetic will be deposited anterior to the QL muscle but posterior to the psoas muscle.
A nerve stimulator at 2 Hz frequency, 1.5 mA will be used to aid in identification of intramuscular placement of the needle.
Local anesthetic will only be deposited if no twitch is seen in either the QL or psoas muscle with an appropriate circuit formed.
For the posterior QL block, a linear or curvilinear probe will be used, at the discretion of the anesthesiologist.
Local anesthetic will be deposited posterior to the QL muscle such that anterior depression of the muscle is seen.
For the lateral QL block, local anesthetic will be deposited lateral to the QL muscle.
|
|
Experimental: Posterior Quadratus Lumborum Block
Participants receive posterior quadratus lumborum block under ultrasound guidance, with 30mL of 1.5% lidocaine on one visit.
|
For the anterior QL block, a curvilinear probe and nerve stimulator will be used.
Local anesthetic will be deposited anterior to the QL muscle but posterior to the psoas muscle.
A nerve stimulator at 2 Hz frequency, 1.5 mA will be used to aid in identification of intramuscular placement of the needle.
Local anesthetic will only be deposited if no twitch is seen in either the QL or psoas muscle with an appropriate circuit formed.
For the posterior QL block, a linear or curvilinear probe will be used, at the discretion of the anesthesiologist.
Local anesthetic will be deposited posterior to the QL muscle such that anterior depression of the muscle is seen.
For the lateral QL block, local anesthetic will be deposited lateral to the QL muscle.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of participants with blocked areas as measured by skin temperature discrimination
Prazo: 60 to 90 minutes post-block
|
Skin temperature assessment using gloved ice on the chest wall, to discriminate blocked vs unblock areas.
|
60 to 90 minutes post-block
|
|
Number of participants with blocked areas as measured by mechanical discrimination
Prazo: 60 to 90 minutes post-block
|
Mechanical assessment using a neuropin (pinprick) on the chest wall, to discriminate blocked vs unblock areas.
|
60 to 90 minutes post-block
|
|
Blocked area as measured by cutaneous distribution mapping
Prazo: 60 to 90 minutes post-block
|
Mapping the blocked area (using the previous temperature and mechanical assessments, demarcating lines on the skin) to calculate the area blocked.
|
60 to 90 minutes post-block
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Skin temperature of the chest wall
Prazo: 60 to 90 minutes post-block
|
Infrared camera will assess skin temperature of the chest wall.
|
60 to 90 minutes post-block
|
|
Blocked area as measured by nociceptive discrimination
Prazo: 60 to 90 minutes post-block
|
Nociceptive stimuli will be delivered using controlled heat to discriminate blocked versus unblocked areas on the chest wall.
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60 to 90 minutes post-block
|
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Lidocaine systemic absorption
Prazo: 0, 30, 60, 120, and 240 minutes after lidocaine administration
|
Calculate lidocaine systemic absorption (Cmax).
|
0, 30, 60, 120, and 240 minutes after lidocaine administration
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of participants with block-related Adverse Events
Prazo: End of study (2 days post blocks)
|
Any block-related adverse events will be recorded.
|
End of study (2 days post blocks)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Brian Mendelson, MD, Duke University
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de janeiro de 2027
Conclusão Primária (Estimado)
1 de abril de 2027
Conclusão do estudo (Estimado)
1 de abril de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
29 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de abril de 2026
Primeira postagem (Real)
5 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
8 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de julho de 2026
Última verificação
1 de abril de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Pro00118381
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
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