Analgesic Effect of Infraspinatus-teres Minor Block for Pre-emptive Analgesia in Patients Undergoing Shoulder Surgeries.

Официальное название

A Novel Approach to Shoulder Analgesia: Infraspinatus-teres Minor Block for Pre-emptive Analgesia in Patients Undergoing Shoulder Surgeries: A Randomized Controlled Study

Обзор

The aim of the study to evaluate the efficacy of the infraspinatus-teres minor (ITM) block in improving pre-emptive analgesia, reducing opioid consumption, and enhancing the overall analgesic effect in patients undergoing shoulder surgeries.

Подробное описание

To compare between infraspinatus-teres minor versus control group (GA):

1. To measure analgesic parameters including: the total amount of rescue analgesic consumption (morphine) in the first 24 hours post-operatively in each group, duration of analgesia, and total amount of intraoperative fentanyl consumption and 2. To assess pain score by using numerical rate scale (NRS) at rest (static) and during passive or active movement of shoulder joint (dynamic). 3. To assess discharge time from post anesthesia care unit (PACU). 4. To assess side effects of systemic opioids (constipation, itching, dizziness, nausea and vomiting) and complications of infraspinatus-tere minor block. 5. Patients' satisfaction: The patients 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 Infraspinatus teres minor block group
  Patients in this group will receive a unilateral ultrasound-guided Infraspinatus-teres minor (ITM) block with injection of local anesthetics (20 mL of bupivacaine 0.25% (50 mg), 50 mcg dexmedetomidine (0.5 ml) and 8 mg dexamethasone (2 ml)) before induction of general anesthesia
• Процедура Control group
  Patients in this group will receive general anesthesia

Первичные конечные точки

• total amount of rescue analgesic consumption [Срок оценки: for 24 hours]
• total amount of intraoperative supplementary fentanyl consumption. [Срок оценки: up to 3 hours]

Вторичные конечные точки (6)

• Numerical Rate Scale (NRS) at rest (static) and during passive or active movement of shoulder (dynamic). [Срок оценки: 30 minutes after arrival in the post-anesthesia care unit (PACU), 2 hours, 4 hours, 8 hours, 12 hours, and 24 hours postoperatively.]
• Time to the first request of rescue analgesia postoperatively [Срок оценки: 24 hours postoperative]
• Discharge time from post anesthesia care unit (PACU) [Срок оценки: 24 hours]
• To assess side effects of systemic opioids [Срок оценки: for 24 hours]
• the incidence of block -related side effects or complications [Срок оценки: for 24 hours]
• patient's satisfaction [Срок оценки: for 24 hours]

Критерии участия

Критерии включения

• • Patients' acceptance.

• Age: Adults aged 21-65 years old.
• BMI: 25-30 kg/m2
• Sex: both sexes (males or females).
• Patients undergoing unilateral shoulder surgey under general anesthesia.
• ASA (American Society of Anesthesiologists) physical status classification I to II.
• Duration of the surgery < 3hours.

Критерии исключения

• • Patients with contraindications to regional anesthesia (e.g. local or systemic infections, or severe neurological or muscular or bleeding disorders or patient on anticoagulant).

• Allergy to study medications: bupivacaine or dexamethasone, or dexmedetomidine
• Patients with severe cardiovascular, respiratory, renal, or hepatic diseases, uncontrolled diabetes , or those undergoing chronic opioid therapy.
• Psychiatric disorders that hinder informed consent or study participation.
• history of neurological diseases or conditions that would affect the efficacy of nerve blocks (e.g., neuropathy, spinal cord injury, or history of severe muscle weakness).
• Patients with nerve injury or disease around the shoulder joint, including thoracic outlet syndrome, Multiple sclerosis, cervical disc disease with ipsilateral radiculopathy, or patients with abnormal sensory or motor function of the upper limb.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 2 центра

• Faculity of medicine, Zagazig university, Zagazig — Zagazig
• Faculty of human medicine, Zagazig university, Zagazig — Zagazig

Идентификаторы

NCT: NCT06999460 · 1299

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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