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NCT Number: NCT07344467

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

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

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Key information

Conditions

Oral Anxiety Anxiety Disorders Melatonin Mental Disorders Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Pregabalin Signs and Symptoms Spine Surgery

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location status: Recruiting

Location contact

Ahmed E Abo Elhkair, MD

SUB_INVESTIGATOR

Ahmed H Ayad, MSc

CONTACT

[email protected]

00201009598637

Gehan M Morsy, MD

SUB_INVESTIGATOR

Laila A Elahwal, MD

SUB_INVESTIGATOR

Shaimaa F Mostafa, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo capsule

Other

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.

Melatonin capsule

Drug

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.

Pregabalin capsule

Drug

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.

Primary outcomes

  1. Degree of pain

    Time frame: 3 days postoperatively

    Postoperative pain will be assessed using the Visual Analogue Scale (VAS) at the following time points: upon arrival to the Post-Anesthesia Care Unit (PACU), and at 1, 2, 4, 6, 8, 12, and 24 hours, as well as at 12 and 24 hours on postoperative days 2 and 3.

Secondary outcomes

  1. Incidence of postoperative anxiety

    Time frame: 3 days postoperatively

    Postoperative anxiety will be assessed using the Hospital Anxiety and Depression Scale (HADS) at the following time points:

    • 2, 6, and 24 hours on postoperative day 1,
    • 12 and 24 hours on both postoperative days 2 and 3.

    According to the HADS scoring system:

    • A score of 0-7 is considered normal,
    • 8-10 indicates a borderline case,
    • 11-21 reflects abnormal anxiety. This assessment timeline enables comprehensive monitoring of anxiety levels during the critical early postoperative period

  2. Postoperative analgesic consumption

    Time frame: 3 days postoperatively

    Postoperative analgesic consumption will be recorded.

  3. Postoperative sleep quality

    Time frame: 3 days postoperatively

    Postoperative sleep quality will be recorded before surgery and every day for three days postoperative.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed H Ayad, MSc

CONTACT

[email protected]

00201009598637

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 15, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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