Effect of Injection Duration of Fascial Plane Blocks on Block Success

Официальное название

Effect of Injection Duration of Fascial Plane Blocks on Block Success and Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy

Обзор

This prospective observational study aims to evaluate the impact of injection duration during fascial plane blocks on block success and analgesic efficacy in patients undergoing laparoscopic cholecystectomy. The hypothesis is that shorter injection durations increase injection pressure, potentially limiting local anesthetic spread, while longer durations facilitate broader anesthetic distribution.

Подробное описание

Fascial plane blocks involve injecting local anesthetics between two anatomical fascial layers, with analgesia achieved by anesthetic diffusion through the fascial plane. However, anesthetic spread may vary significantly based on injection technique, speed, and pressure. This study hypothesizes that injection duration directly influences injection pressure, local anesthetic distribution, and consequently, the extent of sensory blockade and analgesia.

Вмешательства

• Препарат Group O
  Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block block (0.3 ml/kg , %0.25 bupivacaine) will be performed Drug: Tramadol 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; Patient-controlled analgesia settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.
• Препарат Group T
  Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block block (0.3 ml/kg , %0.25 bupivacaine) will be performed Drug: Tramadol 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; Patient-controlled analgesia settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.
• Препарат Group C
  Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block block (0.3 ml/kg , %0.25 bupivacaine) will be performed Drug: Tramadol 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; Patient-controlled analgesia settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.

Первичные конечные точки

• sensory block distribution [Срок оценки: Postoperative 24 hours]

Вторичные конечные точки (3)

• NRS [Срок оценки: Postoperative 24 hours]
• tramadol consumption [Срок оценки: Postoperative 24 hours]]
• Pressure values [Срок оценки: During the procedure]

Критерии участия

Критерии включения

• Laparoscopic cholecystectomy surgery
• Patients with ASA (American Society of Anaesthetists) scores I and III will be included.

Критерии исключения

• Uncontrolled Arterial Hypertension
• Uncontrolled Diabetes Mellitus,
• Mental retardation
• Antidepressant use
• Metabolic disorders
• Bleeding diathesis
• Patients with a body mass index above 30

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Диагностика

Центры проведения

Turkey (Türkiye) · 1 центр

• Bursa Yuksek Ihtisas Training and Research Hospital — Bursa

Идентификаторы

NCT: NCT07096765 · 2024-ТВЕK 2025/07-05

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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