Perioperative Melatonin in Lumbar Laminectomy

University Health Network, Toronto

Status: Unknown

Conditions: Pain and Anxiety in Patients Undergoing Surgery for Lumbar Laminectomy.

Treatments: Dietary Supplement: 5 mg melatonin; Dietary Supplement: 10 mg melatonin; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01126294

09-0172-B

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 3 patient groups, including a placebo group

Melatonin 5 mg

Experimental group

Description:

Patients will receive 5 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.

Treatment:

Dietary Supplement: 5 mg melatonin

Melatonin 10 mg

Experimental group

Description:

Patients will receive 10 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.

Treatment:

Dietary Supplement: 10 mg melatonin

Placebo

Placebo Comparator group

Description:

Patients will receive placebo once the evening before surgery and then again at 90 minutes before surgery.

Treatment:

Dietary Supplement: Placebo