Oral Melatonin Versus Oral Pregabalin on Postoperative Pain and Anxiety Following Spine Surgery

Официальное название

Effect of Oral Melatonin Versus Oral Pregabalin on Postoperative Pain and Anxiety Following Spine Surgery: A Prospective, Randomized Controlled Trial

Обзор

This study aims to compare the efficacy of using Melatonin versus Pregabalin on postoperative pain and anxiety after spine surgeries.

Подробное описание

Spine surgery is one of the most common procedures performed every day which is associated with intense pain in the postoperative period, mostly in the first few days after surgery. Effective pain management leads to improved functional outcomes, early ambulation, prevention of chronic pain and early discharge.

Melatonin is neurohormone mainly secreted from the pineal gland by the suprachiasmatic nucleus. This neurohormone possesses a circadian secretion pattern and regulates the biological clock; it also offers antiemetic, analgesic, and anxiolytic effects.

Pregabalin is a structural analogue of gamma-aminobutyric acid that acts as a potent ligand for alpha 2-delta subunits of the voltage-gated calcium channels in the nervous system. Such action results in a reduction in the depolarization-induced influx of calcium, hence a reduction in the release of excitatory neurotransmitters including glutamate, noradrenaline, dopamine, and serotonin.

Вмешательства

• Другое Placebo capsule
  Patients will be receive one oral placebo capsule the evening before surgery, one oral placebo capsule 2 hours prior to surgery, and one oral placebo capsule in the morning and one in the evening for 3 consecutive days postoperatively.
• Препарат Melatonin capsule
  Participants will receive one 5 mg oral melatonin capsule the evening before surgery, one 5 mg oral melatonin capsule 2 hours prior to surgery, and one oral placebo capsule in the morning, and one 5 mg oral melatonin capsule in the evening, daily for 3 consecutive days postoperatively.
• Препарат Pregabalin capsule
  Participants will receive one 75 mg oral pregabalin capsule the evening before surgery, one 75 mg oral pregabalin capsule 2 hours prior to surgery, and one 75 mg oral pregabalin capsule in the morning, and another in the evening, daily for 3 consecutive days postoperatively.

Первичные конечные точки

• Degree of pain [Срок оценки: 3 days postoperatively]

Вторичные конечные точки (3)

• Incidence of postoperative anxiety [Срок оценки: 3 days postoperatively]
• Postoperative analgesic consumption [Срок оценки: 3 days postoperatively]
• Postoperative sleep quality [Срок оценки: 3 days postoperatively]

Критерии участия

Критерии включения

• Patients aged 21-60 years old.
• Both sexes.
• Patients of American Society of Anesthesiologists (ASA) physical status I \& II.
• Undergoing elective spine surgery.

Критерии исключения

• Patient refusal.
• History of allergic reactions to melatonin or pregabalin.
• Patients with cardiovascular disease (ischemic heart disease, Heart Failure, Arrythmia, Heart Block).
• Patients with kidney disease with (plasma creatinine level > 1.5mg/dl).
• Patients with liver disease with (aspartate transaminase, alanine transaminase, and bilirubin levels more than twice the upper limit of normal).
• Psychological and cognitive disorders; dementia; major depression.
• Circadian rhythm disorders such as chronic fatigue syndrome and drowsiness.

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

• Tanta University — Tanta

Идентификаторы

NCT: NCT07344467 · 36265MD429/6/25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗