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Study of QL Analgesic Response and Extent (SQUARE)

7 de julio de 2026 actualizado 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.

Descripción general del estudio

Descripción detallada

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 estudio

Intervencionista

Inscripción (Estimado)

25

Fase

  • Fase 4

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of participants with blocked areas as measured by skin temperature discrimination
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Skin temperature of the chest wall
Periodo de tiempo: 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
Periodo de tiempo: 60 to 90 minutes post-block
Nociceptive stimuli will be delivered using controlled heat to discriminate blocked versus unblocked areas on the chest wall.
60 to 90 minutes post-block
Lidocaine systemic absorption
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of participants with block-related Adverse Events
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Brian Mendelson, MD, Duke University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de enero de 2027

Finalización primaria (Estimado)

1 de abril de 2027

Finalización del estudio (Estimado)

1 de abril de 2027

Fechas de registro del estudio

Enviado por primera vez

29 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

29 de abril de 2026

Publicado por primera vez (Actual)

5 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

7 de julio de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

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