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Идёт набор NCT07689045

Modified PENG Plus Suprascapular Nerve Block Versus Interscalene Block for Bankart and Latarjet Surgery

Без фазы С лечением Shoulder Instability

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: • Modified PENG Block combined with Suprascapular Nerve Block, • Interscalene Brachial Plexus Block.
Кому может быть актуально
Состояния в реестре: Shoulder Instability. Базовые параметры: 18 лет — 65 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
Египет
Следующий шаг
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Официальное название

Comparative Efficacy of Modified PENG Block Combined With Suprascapular Nerve Block Versus Interscalene Block for Bankart Repair and the Latarjet Surgery : A Randomized Controlled Trial

Обзор

This randomized controlled trial aims to compare the analgesic efficacy and safety of a Modified Pericapsular Nerve Group (PENG) Block combined with Suprascapular Nerve Block (SSNB) versus Interscalene Brachial Plexus Block (ISB) in adult patients undergoing elective Bankart repair or Latarjet surgery under general anesthesia. Seventy patients will be randomized to receive either Modified PENG plus SSNB or ISB. The primary outcome is postoperative pain intensity measured by the Visual Analog Scale (VAS) at 24 hours. Secondary outcomes include opioid consumption, time to first rescue analgesia, functional recovery, range of motion, and block-related complications including respiratory compromise, motor weakness, Horner syndrome, hoarseness, and local anesthetic systemic toxicity. This randomized controlled trial aims to compare the analgesic efficacy and safety of a Modified Pericapsular Nerve Group (PENG) Block combined with Suprascapular Nerve Block (SSNB) versus Interscalene Brachial Plexus Block (ISB) in adult patients undergoing elective Bankart repair or Latarjet surgery under general anesthesia. Seventy patients will be randomized to receive either Modified PENG plus SSNB or ISB. The primary outcome is postoperative pain intensity measured by the Visual Analog Scale (VAS) at 24 hours. Secondary outcomes include opioid consumption, time to first rescue analgesia, functional recovery, range of motion, and block-related complications including respiratory compromise, motor weakness, Horner syndrome, hoarseness, and local anesthetic systemic toxicity.

Подробное описание

Shoulder stabilization procedures such as Bankart repair and the Latarjet procedure are associated with significant postoperative pain. The interscalene brachial plexus block is considered the standard regional anesthetic technique but is associated with complications including phrenic nerve paralysis and motor weakness. This study evaluates whether a Modified PENG Block combined with Suprascapular Nerve Block can provide comparable postoperative analgesia while reducing block-related complications. This is a prospective, single-center, randomized controlled trial involving 70 ASA I-II adult patients undergoing elective shoulder stabilization surgery at Kasr Al-Ainy Hospital, Cairo University. Participants will be randomly allocated to receive either Modified PENG plus SSNB or ISB before general anesthesia. Pain scores, opioid consumption, time to first rescue analgesia, functional recovery, hemodynamic parameters, and adverse events will be assessed during the first 24 postoperative hours and during follow-up according to the study protocol

Вмешательства

  • Процедура • Modified PENG Block combined with Suprascapular Nerve Block
    Ultrasound-guided Modified Pericapsular Nerve Group (PENG) Block combined with Suprascapular Nerve Block (SSNB) performed before induction of general anesthesia. The Modified PENG Block is performed with 20 mL of 0.25% bupivacaine and the SSNB with 10 mL of 0.25% bupivacaine for postoperative analgesia in patients undergoing elective Bankart repair or Latarjet surgery
  • Процедура • Interscalene Brachial Plexus Block
    Ultrasound-guided Interscalene Brachial Plexus Block performed before induction of general anesthesia using 20 mL of 0.25% bupivacaine for postoperative analgesia in patients undergoing elective Bankart repair or Latarjet surgery

Первичные конечные точки

  • Visual Analog Scale (VAS) Pain Score at Rest at 24 Hours Postoperatively [Срок оценки: 24 hours after surgery]
Вторичные конечные точки (2)
  • Visual Analog Scale (VAS) Pain Scores at Postoperative Time Points [Срок оценки: multiple postoperative time points.]
  • Total opioid consumption [Срок оценки: during the first 24 hours.]

Критерии участия

Критерии включения

  • • Male or female patients aged 18 to 65 years.
  • Patients undergoing elective Bankart repair or Latarjet surgery.
  • American Society of Anesthesiologists (ASA) physical status I or II.

Exclusion • Patient refusal.

  • History of allergy to local anesthetics.
  • Chronic opioid use (>3 months).
  • Coagulation disorders.
  • Pre-existing neurological or musculoskeletal disorders.
  • Respiratory compromise (e.g., COPD)

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
  • Faculty of Medicine , Cairo University Hospitals — Cairo

Идентификаторы

NCT: NCT07689045 · MD-248-2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗