Study of QL Analgesic Response and Extent

Официальное название

Anterior Versus Posterior Versus Lateral Quadratus Lumborum Block: a Randomized Control Trial in Healthy Volunteers

Обзор

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.

Подробное описание

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.

Вмешательства

• Комбинированный продукт Quadratus Lumborum with 1.5% Lidocaine
  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 u

Первичные конечные точки

• Number of participants with blocked areas as measured by skin temperature discrimination [Срок оценки: 60 to 90 minutes post-block]
• Number of participants with blocked areas as measured by mechanical discrimination [Срок оценки: 60 to 90 minutes post-block]
• Blocked area as measured by cutaneous distribution mapping [Срок оценки: 60 to 90 minutes post-block]

Вторичные конечные точки (3)

• Skin temperature of the chest wall [Срок оценки: 60 to 90 minutes post-block]
• Blocked area as measured by nociceptive discrimination [Срок оценки: 60 to 90 minutes post-block]
• Lidocaine systemic absorption [Срок оценки: 0, 30, 60, 120, and 240 minutes after lidocaine administration]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07566312 · Pro00118381

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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