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

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

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

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Anxiety; Spine Surgery; Pregabalin; Oral; Melatonin
• Intervention / Treatment: Other: Placebo capsule; Drug: Melatonin capsule; Drug: Pregabalin capsule

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 105
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed H Ayad, MSc; Phone Number: 00201009598637; Email: Ahmed.hamdy@med.tanta.edu.eg

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Recruiting
      • Tanta University
      • Sub-Investigator: Laila A Elahwal, MD
      • Sub-Investigator: Gehan M Morsy, MD
      • Contact: Ahmed H Ayad, MSc; Phone Number: 00201009598637; Email: Ahmed.hamdy@med.tanta.edu.eg
      • Sub-Investigator: Shaimaa F Mostafa, MD
      • Sub-Investigator: Ahmed E Abo Elhkair, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group C (Control Group); 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.	Other: 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.
Experimental: Group M (Melatonin Group); 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.	Drug: 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.
Experimental: Group P (Pregabalin Group); 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of pain	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.	3 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative anxiety	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	3 days postoperatively
Postoperative analgesic consumption	Postoperative analgesic consumption will be recorded.	3 days postoperatively
Postoperative sleep quality	Postoperative sleep quality will be recorded before surgery and every day for three days postoperative.	3 days postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: January 7, 2026
• First Submitted That Met QC Criteria: January 7, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 17, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Anxiety Disorders; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Peptides, and Proteins; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Acids, Acyclic; Carboxylic Acids; Indoles; Amino Acids; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Tryptamines; Pregabalin; Melatonin
• Other Study ID Numbers: 36265MD429/6/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No