Pain and Anxiety in Patients Undergoing Surgery for Lumbar Laminectomy.
Conditions
Keywords
lumbar laminectomy, melatonin, perioperative, pain, anxiety, analgesia, VAS score
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.
Interventions
DIETARY_SUPPLEMENT5 mg melatonin
Patients will receive 5 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.
DIETARY_SUPPLEMENT10 mg melatonin
Patients will receive 10 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.
DIETARY_SUPPLEMENTPlacebo
Patients will receive placebo once the evening before surgery and then again at 90 minutes before surgery.
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Contacts
Primary ContactPhilip Peng, MD
Outcome results
None listed