Perioperative Melatonin in Lumbar Laminectomy

Pain and Anxiety in Patients Undergoing Surgery for Lumbar Laminectomy. Clinical Trial

Official title:

Perioperative Analgesic and Anxiolytic Effect of Melatonin in Patients Undergoing Lumbar Laminectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01126294
• Other study ID #: 09-0172-B
• Status: Recruiting
• Phase: N/A
• First received: May 17, 2010
• Last updated: May 18, 2010
• Start date: April 2010
• Est. completion date: September 2011

Study information

• Verified date: April 2010
• Source: University Health Network, Toronto
• Contact: Philip Peng, MD
• Phone: 416 603-5118
• Email: philip.peng[@]uhn.on.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: September 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain and Anxiety in Patients Undergoing Surgery for Lumbar Laminectomy.

Intervention

Dietary Supplement:
• 5 mg melatonin
Patients will receive 5 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.
• 10 mg melatonin
Patients will receive 10 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.
• Placebo
Patients will receive placebo once the evening before surgery and then again at 90 minutes before surgery.

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Pain will be assessed over a 24 hour period following surgery using a visual analogue scale	24 hours	No
Primary	Anxiety	Anxiety will be assessed over a 24 hour following surgery using visual analogue scale	24 hours	No