Melatonin versus pregabalin for pain and anxiety after spine surgery
Official title: Effect of Oral Melatonin Versus Oral Pregabalin on Postoperative Pain and Anxiety Following Spine Surgery: A Prospective, Randomized Controlled Trial
Run by Tanta University · NCT07344467 · Data updated 2026-11-12
This trial will test whether taking melatonin or pregabalin around the time of elective spine surgery reduces postoperative pain and anxiety in adults aged 21–60.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years to 60 Years |
| Sex | All |
| Enrollment | 105 (estimated) |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El-Gharbia) |
| Status | Recruiting |
| Started | January 17, 2026 |
| Main results expected | June 1, 2027 |
| Study ends | June 1, 2027 |
| Registry record updated | January 21, 2026 |
| Trial ID | NCT07344467 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 21–60 years old with ASA physical status I–II who are scheduled for elective spine surgery and do not have significant heart, kidney, liver disease, circadian rhythm disorders, or allergy to the study drugs.
✕Probably not a fit
Patients with cardiovascular disease, significant renal or hepatic impairment, major psychiatric or cognitive disorders, circadian rhythm disorders, or those outside the age range are unlikely to benefit or be eligible for this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults scheduled for elective spine surgery at Tanta University receive one of three oral capsules (melatonin, pregabalin, or placebo) and are followed through the immediate postoperative period to compare pain and anxiety outcomes. The study enrolls ASA I–II patients between 21 and 60 years old and excludes those with significant cardiac, renal, hepatic, or certain psychiatric disorders. Pain and anxiety are measured primarily in the first days after surgery when postoperative discomfort is usually most intense, with additional functional and recovery endpoints recorded. The design compares the two active agents head-to-head against placebo to determine relative effectiveness and safety.
Why it matters
Potential benefit: If successful, this could identify an effective, low-cost option to reduce postoperative pain and anxiety and possibly lower opioid use after spine surgery.
How similar studies have gone: Pregabalin has shown benefit in multiple trials for reducing postoperative pain and opioid use while melatonin has smaller, mixed studies suggesting anxiolytic and modest analgesic effects, so a direct comparison is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Tanta University
Tanta, El-Gharbia, Egypt Recruiting
Study contacts
- Study coordinator: Ahmed H Ayad, MSc
- Email: Ahmed.hamdy@med.tanta.edu.eg
- Phone: 00201009598637
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.