Ultrasound Guided Paravertebral Block Versus Erector Spinae Block for Postoperative Analgesia After Inguinal Hernia Repair in Pediatric Patients

Официальное название

Ultrasound Guided Paravertebral Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Inguinal Hernia Repair in Pediatric Patients: a Randomized Clinical Trial

Обзор

The aim of the study is to compare postoperative analgesia in pediatric patients undergoing inguinal hernia repair by comparing the efficacy of ultrasound guided paravertebral block versus ultrasound guided erector spinae plane block.

Подробное описание

* To assess the total amount of rescue analgesic consumption in the first 24 hours post-operatively in each group. * To measure the time of first request of rescue analgesia and to assess pain intensity at rest (static) and after movement or coughing (dynamic) using 10 points Modified Objective Pain Score (MOPS). * To record the incidence of complications (hematoma, local anesthetic toxicity, pneumothorax, infection, hypotension, epidural or intrathecal spread). * Over all parent's satisfaction: The parents will be asked to rate the overall degree of satisfaction of the analgesia by using a 5-points likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia).

Вмешательства

• Процедура ultrasound guided paravertebral block
  after sterilization and identifying the level of T10 ,linear ultrasound probe will be placed in the midline over the spinous process at the chosen level, then the probe will be moved laterally to view the lamina and hyperechoic transverse process ,the pleural should be visible as a bright white line .The needle should be inserted in -plane from lateral to medial and the needle tip should end in a hypoechoic triangular space. Correct needle placement should be confirmed by anterior displacement o
• Процедура Ultrasound guided erector spinae plane block
  After sterilization, the linear ultrasound probe will be placed over transverse process of T10 ,after optimizing the image in sagittal or transverse scanning ,A 50 mm 22-G needle will be placed under the erector spinae muscle in -in plane orientation until it contacted T8 transverse process in the cranial caudal direction ,after hydro dissection and confirmation that the tip of the needle is between the transverse process and the fascia of the erector spinae muscle group, 0.5 ml/kg of a mixture
• Процедура control group C
  will receive standard general anesthesia with pain management protocol without regional block.

Первичные конечные точки

• The total amount of rescue analgesia (Ibuprofen consumption) [Срок оценки: for 24 hours postoperative]

Вторичные конечные точки (5)

• Pain intensity at rest (static) and after movement or coughing (dynamic) [Срок оценки: 0 minutes immediate postoperative ( on arrival to PACU), 30 minutes, 1hs, 2hs, 4hs, 8hs, 12 hrs and 24hs postoperatively]
• The time to first request of rescue analgesia (Ibuprofen) [Срок оценки: for 24 hours postoperative]
• The total number of patients requiring additional dose of intraoperative fentanyl. [Срок оценки: during operation period]
• To record the incidence of complications [Срок оценки: 24 hours postoperative]
• Over all parent's satisfaction [Срок оценки: 24 hours postoperative]

Критерии участия

Критерии включения

1 - Parents acceptance

2\. Age: preschool and school age child (24 months-12 years old).

3\. Sex: both sex (males or females).

4\. Physical status: ASA 1\& II.

5\. Type of operation: elective unilateral inguinal hernia repair

Критерии исключения

1- Patient with any contraindications of regional blocks (as coagulopathy or local infection at injection site)

2\. Patients with known history of allergy to the study drugs (bupivacaine and lidocaine).

3\. Advanced hepatic, renal, cardiovascular, neurologic and respiratory diseases.

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

Лечение

Центры проведения

Египет · 2 центра

• faculty of human medicine, Zagazig university hospitals — El Sharkia
• Faculty of Human Medicine, Zagazig University — El Sharkia

Идентификаторы

NCT: NCT06752252 · 866

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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