Perioperative Melatonin in Lumbar Laminectomy

• Sponsor: University Health Network, Toronto (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01126294
• Collaborator: (none)
• Enrollment: 84
• Location: 1
• Arms: 3
• Duration (Months): 17
• Patients Per Site Per Month: 4.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain and Anxiety in Patients Undergoing Surgery for Lumbar Laminectomy.	Dietary Supplement: 5 mg melatonin; Dietary Supplement: 10 mg melatonin; Dietary Supplement: Placebo	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Perioperative Analgesic and Anxiolytic Effect of Melatonin in Patients Undergoing Lumbar Laminectomy
• Study Start Date: Apr 1, 2010
• Anticipated Primary Completion Date: Jul 1, 2011
• Anticipated Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Melatonin 5 mg Patients will receive 5 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.	Dietary Supplement: 5 mg melatonin; Patients will receive 5 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.
Experimental: Melatonin 10 mg Patients will receive 10 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.	Dietary Supplement: 10 mg melatonin; Patients will receive 10 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.
Placebo Comparator: Placebo Patients will receive placebo once the evening before surgery and then again at 90 minutes before surgery.	Dietary Supplement: Placebo; Patients will receive placebo once the evening before surgery and then again at 90 minutes before surgery.

Outcome Measures

Primary Outcome Measures

1. Pain [24 hours]

   Pain will be assessed over a 24 hour period following surgery using a visual analogue scale

2. Anxiety [24 hours]

   Anxiety will be assessed over a 24 hour following surgery using visual analogue scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Toronto Western Hospital	Toronto	Ontario	Canada	M5T 2S8

Sponsors and Collaborators

• University Health Network, Toronto

Investigators

• Principal Investigator: Philip Peng, MD, University Health Network, Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01126294
• Other Study ID Numbers: 09-0172-B
• First Posted: May 19, 2010
• Last Update Posted: May 19, 2010
• Last Verified: Apr 1, 2010

• Keywords provided by , ,: lumbar laminectomy, melatonin, perioperative, pain, anxiety, analgesia, VAS score
• Additional relevant MeSH terms: Melatonin

Study Results

No Results Posted as of May 19, 2010