Oral Melatonin Versus Oral Pregabalin on Postoperative Pain and Anxiety Following Spine Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo capsule, Melatonin capsule, Pregabalin capsule.
- Who it may be relevant to
- Registry conditions: Oral, Melatonin, Pregabalin, Postoperative Pain. Basic parameters: 21 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Oral Melatonin Versus Oral Pregabalin on Postoperative Pain and Anxiety Following Spine Surgery: A Prospective, Randomized Controlled Trial
Overview
This study aims to compare the efficacy of using Melatonin versus Pregabalin on postoperative pain and anxiety after spine surgeries.
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.
Interventions
- 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. - 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. - 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.
Primary outcome measures
- Degree of pain [Time frame: 3 days postoperatively]
Secondary outcome measures (3)
- Incidence of postoperative anxiety [Time frame: 3 days postoperatively]
- Postoperative analgesic consumption [Time frame: 3 days postoperatively]
- Postoperative sleep quality [Time frame: 3 days postoperatively]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Tanta University — Tanta
Identifiers
NCT: NCT07344467 · 36265MD429/6/25