COMPARISON of the EFFECT of TWO DIFFERENT ANALGESIS TECHNIQUES in ABDOMINAL HYSTERECTOMY

Официальное название

Comparison of the Analgesic Effect of Intrathecal Morphine and Bilateral Transversus Abdominis Plane Block in Patients Undergoing Elective Abdominal Hysterectomy

Обзор

Hysterectomy is one of the most commonly performed surgical procedures after cesarean section in many countries worldwide, especially among women of reproductive age. Postoperative pain is typically managed with oral and parenteral narcotics. Patient-controlled analgesia (PCA) is an effective pain management method that provides advantages such as faster pain relief, better dosage control, and elimination of the need for timer adjustments. Facilitating the recovery process and optimizing postoperative pain management are crucial components of perioperative care. To minimize systemic opioid requirements and opioid-related side effects, multimodal analgesia combining local anesthesia, peripheral, and non-opioid analgesics has become increasingly popular.

Вмешательства

• Другое Intratechal Morphine
  Prior to induction, the patient will be positioned seated, and morphine will be slowly injected intrathecally at a dose of 5 μg/kg, adjusted to the L4-L5 or L3-L4 intervertebral space using a 27G pencil point spinal needle. The injection will be administered over approximately 10 seconds
• Другое Transversalis Fascia Plane Block
  Prior to induction, patients will be positioned supine, and bilateral transversus abdominis plane (TAP) block will be performed with the aid of ultrasound. As the blocking agent, 20 cc of 0.25% bupivacaine will be used bilaterally.

Первичные конечные точки

• Postoperatve Opioid Consumption [Срок оценки: postoperatively 24 hours]

Вторичные конечные точки (3)

• Postoperative Pain Scores at movement and rest [Срок оценки: postoperatively 24 hours]
• Quality of recovery 24 hours after the surgery assessed using QoR-40 questionnaire [Срок оценки: postoperative 24 hour]
• Advers Event [Срок оценки: postoperative 24 hour]

Критерии участия

Критерии включения

• Women aged between 18 and 65 years classified as ASA 1 and ASA 2.

Критерии исключения

• Patients with allergies to the active substance, those with severe liver or renal insufficiency, a history of long-term nonsteroidal anti-inflammatory drug (NSAID) and opioid analgesic use, a history of gastrointestinal bleeding, peptic ulcer or inflammatory bowel disease, a history of diabetes or other neuropathic conditions, preoperative atrioventricular block and bradycardia, underlying serious respiratory diseases, a history of psychiatric disorders, patients classified as ASA stage 3 or higher, patients weighing less than 40 kg, patients unable to use the patient-controlled analgesia (PCA) device, and patients who need to discontinue the study medication during surgery for any reason will be excluded from the study

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

Четверное слепое

Основная цель

Другое

Центры проведения

Turkey (Türkiye) · 1 центр

• Ataturk University — Erzurum

Идентификаторы

NCT: NCT06815393 · 2024-04/07

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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