Health TrialsbyHealthPanel

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

ConditionsOralMelatoninPregabalinPostoperative PainAnxietySpine Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-60
SponsorTanta University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 21-60 years old.

Both sexes.

Patients of American Society of Anesthesiologists (ASA) physical status I & II.

Undergoing elective spine surgery.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Placebo capsule

    Other intervention

    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.

  • Melatonin capsule

    Drug

    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.

  • Pregabalin capsule

    Drug

    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.

Treatment groups

105 Participants
are divided into 3 treatment groups
Group A: Group C (Control Group)Placebo comparator 1 intervention
Group B: Group M (Melatonin Group)Experimental treatment 1 intervention
Group C: Group P (Pregabalin Group)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 days postoperatively

Secondary outcomes

1

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: 1. A score of 0-7 is considered normal, 2. 8-10 indicates a borderline case, 3. 11-21 reflects abnormal anxiety. This assessment timeline enables comprehensive monitoring of anxiety levels during the critical early postoperative period

Time frame
3 days postoperatively
2

Postoperative analgesic consumption

Postoperative analgesic consumption will be recorded.

Time frame
3 days postoperatively
3

Postoperative sleep quality

Postoperative sleep quality will be recorded before surgery and every day for three days postoperative.

Time frame
3 days postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov
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