Actively Recruiting
Effect of Oral Melatonin Versus Oral Pregabalin on Postoperative Pain and Anxiety Following Spine Surgery: A Prospective, Randomized Controlled Trial
Led by Tanta University · Updated on 2026-01-21
105
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how oral melatonin compares to oral pregabalin for managing pain and anxiety after spine surgery. This trial focuses on adults aged 21 to 60 undergoing elective spine surgery and explores relief during the critical first few days after surgery. Melatonin is a natural hormone with effects on sleep, pain, and anxiety, while pregabalin is a medication that affects nerve signals to reduce pain sensations. Participants are randomly assigned to one of three groups: a placebo group receiving inactive capsules, a melatonin group receiving 5 mg melatonin capsules at specified times, and a pregabalin group receiving 75 mg pregabalin capsules. The dosing schedule includes capsules the evening before surgery, two hours prior to surgery, and then twice daily for three days after surgery. The study uses a double-blind design to ensure unbiased results. During the study, participants will be monitored for pain levels, anxiety, analgesic use, and sleep quality for three days after surgery. Researchers will collect data on these outcomes to compare the effects of melatonin and pregabalin. The trial is sponsored by Tanta University and is planned to run until June 2027, with participants undergoing assessments throughout the postoperative period to evaluate the treatments' impact.
CONDITIONS
Brief Title
Oral Melatonin Versus Oral Pregabalin on Postoperative Pain and Anxiety Following Spine Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 21-60 years old
- Both sexes
- Patients of American Society of Anesthesiologists (ASA) physical status I & II
- Undergoing elective spine surgery
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 1 day
Participants undergo spine surgery and receive oral capsules starting the evening before surgery and continuing through the surgery day.
1 visit (in-person) for surgery and medication administration
Duration - 3 days
Participants take oral capsules (melatonin, pregabalin, or placebo) twice daily for 3 consecutive days following surgery to manage pain and anxiety.
Daily medication administration with visits as part of routine postoperative care
Trial Site Locations
Total: 1 location
1
Tanta University
Tanta, El-Gharbia, Egypt, 31527
Actively Recruiting
Research Team
A
Ahmed H Ayad, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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