Идёт набор NCT04941664

Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block

Без фазы С лечением Musculoskeletal Diseases or Conditions

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: 0.5% levobupivacaine.
Кому может быть актуально: Состояния в реестре: Musculoskeletal Diseases or Conditions. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Гонконг
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Minimum Effective Local Anesthetic Volume of 0.5% Levobupivacaine Required for Ultrasound Guided Superior Trunk Block for Shoulder Surgery

Обзор

The objective of this study is to identify the minimum effective dosage of a commonly used local anaesthetic drug "levobupivacaine" required to produce an effective ultrasound guided (USG) superior trunk block (STB) in at least 90% of patients for shoulder arthroscopic surgeries.

Подробное описание

Shoulder arthroscopic surgery is one of the most commonly performed procedures worldwide, and associated with significant postoperative pain. Currently, such surgery is performed either under general anaesthesia or under Interscalene brachial plexus block (ISBPB), which is a regional anaesthesia technique. However, ISBPB is associated with the highest incidence of hemi-diaphragmatic palsy of the operative side. Since majority of the innervation to the shoulder arises from or passes through the superior trunk of the brachial plexus, superior trunk block has been shown to have lesser impact on the phrenic nerve and it has been gaining popularity worldwide. Ultrasound is widely used for brachial plexus block and current evidence indicates that it is feasible to accurately identify majority of the main components of the brachial plexus above the clavicle, including the three trunks (superior, middle, and inferior trunks). However, there are no data describing an optimal volume of local anaesthetic for superior trunk block. The aim of this study is to identify the minimum effective dosage of a commonly used local anaesthetic drug "levobupivacaine" required to produce an effective ultrasound guided (USG) superior trunk block (STB) in at least 90% of patients for shoulder arthroscopic surgeries.

Вмешательства

Препарат 0.5% levobupivacaine
This study adopts a "Modified Narayana rule (MNR)", a sequential up-and-down pharmacodynamics method (UDM) to estimate the minimum effective local anesthetic volume of 90% (MELVA90) of cases of the aforementioned local anesthetic (LA), in order to produce the surgical anesthesia of the patients scheduled for shoulder surgeries. Based on the principal investigator's clinical experience, the initial volume of 8ml will be used. Depending on the success or failure of the superior trunk block, which

Первичные конечные точки

Changes of sensory & motor blockade (Readiness for surgery) of the upper extremity [Срок оценки: within 45 minutes after the block at 5 minutes interval]
Minimum effective volume (ml) of local anesthetic agent [Срок оценки: after nerve block till end of surgery]

Вторичные конечные точки (8)

Changes of motor blockade of the upper extremity [Срок оценки: within 45 minutes after the block at 5 minutes interval]
Changes of sensory block of the upper extremity [Срок оценки: within 45 minutes after the block at 5 minutes interval]
Percentage changes of the Diaphragmatic function [Срок оценки: Baseline (before block) and at 30 minutes after block]
Changes of the Extensiveness of Diaphragmatic function [Срок оценки: calculated after block]
Block performance time [Срок оценки: assess once before surgery]
Discomfort score [Срок оценки: assess once before surgery]
Paresthesia [Срок оценки: during the period of undergoing the nerve block]
Complications [Срок оценки: during the nerve block till the end of surgery]

Критерии участия

Критерии включения

American Society of Anesthesiologists (ASA) physical status I-III scheduled to undergo elective upper shoulder arthroscopic rotator cuff repair procedure