Perioperative Melatonin in Lumbar Laminectomy

Not Applicable

• Conditions: Pain and Anxiety in Patients Undergoing Surgery for Lumbar Laminectomy.
• Interventions: Dietary Supplement: 5 mg melatonin; Dietary Supplement: 10 mg melatonin; Dietary Supplement: Placebo

• Registration Number: NCT01126294
• Lead Sponsor: University Health Network, Toronto

Brief Summary

Patients undergoing lumbar laminectomy surgery will receive either 5 or 10 mg melatonin or placebo once the evening before surgery and again 90 minutes before surgery. Pain and anxiety will be assessed over the 24 hour period following surgery.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-04
• Study Start: 2010-04
• Study First Submitted: 2010-05-17
• Study First Submitted QC: 2010-05-18
• Last Update Submitted: 2010-05-18
• Study First Posted: 2010-05-19
• Last Update Posted: 2010-05-19
• Primary Completion: 2011-07
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• age 18 to 65 years old
• ASA status 1-3
• having lumbar laminectomy 2 to 3 levels with or without fusion

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Exclusion Criteria

• receiving emergent procedure
• surgery for neoplastic spine lesion
• allergy to melatonin or its non-medicinal ingredients
• allergy or contraindication
• BMI over 35 or or less than 20 kg/m2
• pregnancy or breastfeeding
• failure to provide informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Melatonin 5 mg	5 mg melatonin	Patients will receive 5 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.
Melatonin 10 mg	10 mg melatonin	Patients will receive 10 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.
Placebo	Placebo	Patients will receive placebo once the evening before surgery and then again at 90 minutes before surgery.

Primary Outcome Measures

Name	Time	Method
Pain	24 hours	Pain will be assessed over a 24 hour period following surgery using a visual analogue scale
Anxiety	24 hours	Anxiety will be assessed over a 24 hour following surgery using visual analogue scale

Trial Locations

Locations (1)

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada