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

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

Recruiting
21-60 years
All
Phase N/A

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Overview

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

Description

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.

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study details
    Oral
    Melatonin
    Pregabalin
    Postoperative Pain
    Anxiety
    Spine Surgery

NCT07344467

Tanta University

1 February 2026

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