Comparison of Different Epidural Lidocaine-Bupivacaine Mixtures for Lower Limb Surgeries
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Lidocaine-Bupivacaine Epidural Mixture (High-dose Lidocaine).
- Кому может быть актуально
- Состояния в реестре: Epidural Dosage of Lidocaine Bupivacaine in Lower Limb Surgeries. Базовые параметры: 20 лет — 60 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
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- Пакистан
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Официальное название
Comparison of the Outcomes of Epidural Injection of Different Lidocaine-Bupivacaine Mixtures for Lower Limb Surgeries at a Tertiary Care Hospital, Karachi
Обзор
This randomized controlled trial will evaluate different epidural lidocaine-bupivacaine mixtures in patients undergoing lower limb surgery at a tertiary care hospital in Karachi, Pakistan. Ninety-six participants will be randomly assigned to one of three study groups receiving different combinations of lidocaine and bupivacaine for epidural anesthesia. The purpose of this study is to determine which anesthetic mixture provides the most effective anesthesia for lower limb surgery. The study will compare the speed of onset and duration of anesthesia, as well as the effects of the anesthetic mixtures on cardiovascular stability during surgery. The results of this study may help identify an epidural anesthetic regimen that provides optimal surgical conditions, effective pain control, and stable hemodynamic parameters for patients undergoing lower limb procedures.
Подробное описание
Lower limb surgeries are commonly associated with significant perioperative and postoperative pain, requiring effective anesthetic techniques to provide adequate analgesia and improve patient outcomes. Epidural anesthesia is widely used because it offers effective intraoperative anesthesia, prolonged postoperative pain relief, improved physiological responses to surgical stress, and enhanced patient satisfaction. Local anesthetic agents such as lidocaine and bupivacaine are commonly administered for epidural blockade due to their different pharmacological characteristics.
Lidocaine has a rapid onset of action but a relatively shorter duration, whereas bupivacaine provides prolonged analgesia but has a slower onset of action. Combining these agents may provide the advantages of both drugs by achieving rapid onset with longer duration of action while maintaining hemodynamic stability.
This randomized controlled trial will be conducted at the Department of Anaesthesiology and Surgical ICU, Shaheed Mohtarma Benazir Bhutto Institute of Trauma, Karachi. Ninety-six patients aged 20-60 years, ASA class I and II, undergoing lower limb surgeries under epidural anesthesia will be enrolled and randomized equally into three groups.
Group A: 10 ml of 0.5% isobaric bupivacaine + 5 ml of 2% lidocaine Group B: 10 ml of 0.5% isobaric bupivacaine + 2.5 ml of 2% lidocaine + 2.5 ml normal saline Group C: 10 ml of 0.5% isobaric bupivacaine + 5 ml normal saline
The primary outcomes assessed will include time to onset of sensory blockade at T10 level, time to onset of motor blockade to Bromage Grade II, and duration of motor blockade until recovery to Bromage Grade I. Hemodynamic variables including mean arterial pressure and heart rate will also be recorded and compared among groups.
The study aims to determine the optimal epidural lidocaine-bupivacaine mixture that provides faster onset of anesthesia, adequate duration of block, and stable hemodynamic effects in patients undergoing lower limb surgeries.
Вмешательства
- Препарат Lidocaine-Bupivacaine Epidural Mixture (High-dose Lidocaine)
Intervention 1: Lidocaine-Bupivacaine Epidural Mixture (High-dose Lidocaine) Epidural administration of a total volume of 15 ml containing 10 ml of 0.5% isobaric bupivacaine and 5 ml of 2% lidocaine for anesthesia during lower limb surgery. Intervention 2: Lidocaine-Bupivacaine Epidural Mixture (Low-dose Lidocaine) Epidural administration of a total volume of 15 ml containing 10 ml of 0.5% isobaric bupivacaine, 2.5 ml of 2% lidocaine, and 2.5 ml of normal saline for anesthesia during lower limb
Первичные конечные точки
- Time to Onset of Sensory Blockade [Срок оценки: From completion of epidural injection until achievement of sensory block at the T10 dermatome level, assessed up to 20 minutes.]
Вторичные конечные точки (4)
- Time to Onset of Motor Blockade [Срок оценки: From completion of epidural injection until achievement of Bromage Grade II motor blockade, assessed up to 20 minutes.]
- Duration of Motor Blockade [Срок оценки: From achievement of Bromage Grade II motor blockade until complete recovery of motor function, assessed up to 8 hours after epidural injection.]
- Mean Arterial Pressure [Срок оценки: From epidural injection until completion of surgery, assessed up to 3 hours.]
- Heart Rate [Срок оценки: From epidural injection until completion of surgery, assessed up to 3 hours.]
Критерии участия
Критерии включения
Patients undergoing lower limb surgeries under epidural block Age between 20-60 years Either gender American Society of Anesthesiologists (ASA) physical status I and II Patients willing to provide informed consent
Критерии исключения
Contraindications to regional anesthesia including patient refusal and bleeding diathesis History of allergy to local anesthetics Patients undergoing emergency surgeries Deformities of the spine History of hypothyroidism or hyperthyroidism Pregnant patients
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Пакистан · 1 центр
- Shaheed Mohtarma Benazir Bhutto Institute of Trauma — Karachi
Идентификаторы
NCT: NCT07648784 · THussain · SMBBIT