RecruitingNot ApplicableNCT07344467

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

Sponsor

Tanta University

Enrollment

105 participants

Start Date

Jan 17, 2026

Study Type

INTERVENTIONAL

Conditions

Postoperative Pain Anxiety Oral Melatonin Pregabalin Spine Surgery

Summary

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

Eligibility

Min Age: 21 YearsMax Age: 60 Years

Inclusion Criteria4

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

Exclusion Criteria7

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.

Interventions

OTHERPlacebo 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.

DRUGMelatonin 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.

DRUGPregabalin 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.