Ketorolac Intravenous Regional Analgesia in Lower Limb Surgeries

Официальное название

Ketorolac for Intravenous Regional Analgesia in Lower Limb Orthopedic Surgeries Under Spinal Anesthesia: A Randomized Control Study

Обзор

Tourniquet, a compressing device, otherwise its use in intravenous regional anesthesia, is commonly used in particular orthopedic surgeries. From the previous documented effectiveness and safety of intravenous (IV) administration of ketorolac in the circulatory-isolated limb as a part of intravenous regional anesthesia; we hypothesized that in orthopedic surgeries done with tourniquet, intravenous (IV) administration of ketorolac after tourniquet inflation, will act as intravenous regional analgesia. So, it will prolong the postoperative analgesic duration as a primary outcome.

Подробное описание

This is a randomized controlled trial that tests the effecacy of the intravenous regional ketorolac in lower limb orthopedic surgeries with spinal anesthesia. The investigators will compare the effect of 30 mg ketorolac without local anesthetic in the injected intravenously in an isolated lower limb (with torniquet) versus intravenous 30 mg ketorolac administered 10 minutes before toniquet pressuerization on the postoperative analgesia.

All patients will receive spinal anesthesia aiming for at least T12-L1 level. Postoperative standard analgesia will be paracetamol and diclofenac, given for both groups.

Вмешательства

• Препарат Ketorolac
  After confirmation of circulatory isolation of the operated limb by the inflated tourniquet, 30 mg ketorolac tromethamine diluted in normal saline in a total volume of 50 ml will be injected
• Другое Control
  After confirmation of circulatory isolation of the operated limb by the inflated tourniquet, 50 ml normal saline without drugs will be injected

Первичные конечные точки

• The postoperative analgesic duration [Срок оценки: within 24 hours after the surgery]

Вторичные конечные точки (5)

• Postoperative pain at rest [Срок оценки: at 2, 4, 6, 12, 24 hours after 24 hours after surgery]
• Postoperative pain at movement [Срок оценки: at 2, 4, 6, 12, 24 hours after 24 hours after surgery]
• Total postoperative analgesic consumption [Срок оценки: within the first 24 hours after surgery]
• time to sensory recovery from spinal anesthesia [Срок оценки: through the intraoperative or postoperative care unit]
• time to motor recovery from spinal anesthesia [Срок оценки: through the intraoperative or postoperative care unit]

Критерии участия

Критерии включения

• American Society of Anesthesiologists physical status I or II
• Elective unilateral lower limb orthopedic surgery with tourniquet under spinal anesthesia

Критерии исключения

• Pregnant females
• Body mass index ≥ 35 kg/m2
• Allergy to ketorolac
• Had renal, asthmatic, vascular (Raynaud's syndrome) disease, hematological anemias
• Had any history of gastrointestinal tract inflammation, bleeding, ulceration, or perforation besides
• Edema in the operated limb grade ≥ 3

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

Профилактика

Центры проведения

Египет · 1 центр

• Mansoura University Hospitals — Al Mansurah

Идентификаторы

NCT: NCT05543785 · R.22.09.1832

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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