RLB vs ERSP for Postoperative Analgesia in Lap Cholecystectomy

Официальное название

Retrolaminar Block Versus Erector Spinae Plane Block for Postoperative Analgesia in Laparoscopic Cholecystectomy: A Comparative Randomized Prospective Study

Обзор

This prospective, randomized, double-blind clinical trial evaluates the comparative effectiveness of ultrasound-guided retrolaminar block (RLB) and erector spinae plane block (ESPB) for postoperative analgesia in patients undergoing laparoscopic cholecystectomy. A total of 100 ASA I-II patients, aged 20-60 years, will be randomly allocated into two equal groups to receive either RLB or ESPB bilaterally following induction of standardized general anesthesia. The primary outcome is the time to first request for rescue analgesia, while secondary outcomes include total morphine consumption within the first 24 hours, postoperative pain scores assessed using the Numeric Rating Scale (NRS), patient satisfaction, and the incidence of adverse events. Pain assessment will be performed at predefined intervals over the first 24 hours postoperatively. The study aims to determine which technique provides superior analgesia with reduced opioid requirements and improved patient outcomes.

Вмешательства

• Биопрепарат Retrolaminar Block (RLB)
  Patients will be positioned laterally, and a curved ultrasound probe will be aligned longitudinally at the T7 vertebra. The vertebral lamina and spinous process will be identified. A needle will be inserted 1 - 1.5 cm lateral to the spinous process, advanced toward the lamina, and 20 mL of LA mixture will be injected into the fascial plane between the lamina and transversus spinae muscles bilaterally.
• Процедура Erector spinae plane block (ESPB)
  The blocks will be conducted at the level of the T7 spinous process (SP) with the patient in the lateral position and the arm abducted. Using US ( curved probe ) , the T7 transverse process (TP) is identified by counting from the 12th rib. The US probe is positioned 2 - 3 cm laterally to the SP of T7 and situated over the TP of T7/T8 in the parasagittal longitudinal plane, with the erector spinae muscle (ESM) visualized over the TP. The needle is then inserted and advanced in plane from cephalad

Первичные конечные точки

• Time to the 1st rescue analgesia [Срок оценки: in the 1st 24hr.]

Вторичные конечные точки (3)

• Total morphine consumption [Срок оценки: in the 1st 24hr.]
• Pain score. [Срок оценки: Pain will be assessed at, 2, 4, 6, 8, 12, 18 and 24 hour postoperatively.]
• Degree of patient satisfaction [Срок оценки: in the first 24 hours after surgery]

Критерии участия

Критерии включения

• • Age from 20 to 60 years.

• Both sexes.
• American Society of Anesthesiology (ASA) grade I and II physical status.
• Patients will undergo cholecystectomy under general anesthesia.

Критерии исключения

• • Sensitivities or contraindications to the study medications.

• Infection at the site of injection.
• Emergency surgery.
• Body mass index (BMI) > 35.
• Organic comorbidities.
• Histories of psychological conditions and/or chronic pain syndromes.
• Contraindications to regional anesthesia.
• Severe respiratory, cardiac, hepatic and renal disorders.
• Pregnancy.
• Coagulopathy.
• Opioid addiction.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Sohag Faculty of Medicine — Sohag

Идентификаторы

NCT: NCT07598162 · soh-Med-26-3-9MS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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