Effect of Melatonin On Pain In Patients Undergoing Lower Limb Surgery: A Randomized Open Label study- PG Dissertation
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Mohammed faisel h a
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- 1) To assess the effect of Melatonin on post operative pain relief in patients undergoing lower limb orthopedic surgery using Visual Analog Scale
Overview
Brief Summary
Post operative pain is common in patients undergoing surgery and effective control is required to reduce post operative complications, improve patient satisfaction and facilitate early recovery. Melatonin was observed to be effective in treatment of sleep disorder, anxiety and painful conditions. Melatonin also has antiemetic, analgesic and anti-inflammatory effects. While many studies have investigated the analgesic effect of melatonin, there are few studies evaluating its role in post operative pain relief following surgical procedures for lower limb fractures in india.
OBJECTIVES OF STUDY:
-
To assess the effect of Melatonin on post operative pain relief in patients undergoing lower limb orthopedic surgery using Visual Analog Scale
-
To study the effect of melatonin on peri-operative anxiety using Visual Analog Scale for Anxiety (VAS-A)
-
To evaluate the safety profile of melatonin using WHO causality scale
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 20.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •patients undergoing elective lower limb orthopedic surgery under spinal anesthesia 2)patients belonging to American society of anesthesiologists (ASA) grade 1 and grade 2.
Exclusion Criteria
- •patients who have used opioids within 12 hours before the surgery 2)chronic alcoholics 3)patients on nifedipine, benzodiazepines, non-benzodiazepines and beta blockers within a week before admission 4)patients with sleep disorders, diabetes mellitus, depressive disorder, allergy to study drugs, abnormal baseline liver function tests or expected compliance problems due to known psychiatric disease and epilepsy 5)pregnant or lactating women.
Outcomes
Primary Outcomes
1) To assess the effect of Melatonin on post operative pain relief in patients undergoing lower limb orthopedic surgery using Visual Analog Scale
Time Frame: 1) Intensity of pain measured using Visual Analog Scale at baseline(before study medication is administered) and at 2,4,6,8,12,24,48,72,96 and 120 hours. | 2) BPAS score at baseline and at 12,24,48,72,96 and 120 hours. | 3) FAS at baseline and at 2,4,6,8,12,24,48,72,96 and 120 hours. | 4) VAS-A score at baseline, 6, 12 and 24hrs post surgery
2) To study the effect of melatonin on peri-operative anxiety using Visual Analog Scale for Anxiety (VAS-A)
Time Frame: 1) Intensity of pain measured using Visual Analog Scale at baseline(before study medication is administered) and at 2,4,6,8,12,24,48,72,96 and 120 hours. | 2) BPAS score at baseline and at 12,24,48,72,96 and 120 hours. | 3) FAS at baseline and at 2,4,6,8,12,24,48,72,96 and 120 hours. | 4) VAS-A score at baseline, 6, 12 and 24hrs post surgery
3) To evaluate the safety profile of melatonin using WHO causality scale
Time Frame: 1) Intensity of pain measured using Visual Analog Scale at baseline(before study medication is administered) and at 2,4,6,8,12,24,48,72,96 and 120 hours. | 2) BPAS score at baseline and at 12,24,48,72,96 and 120 hours. | 3) FAS at baseline and at 2,4,6,8,12,24,48,72,96 and 120 hours. | 4) VAS-A score at baseline, 6, 12 and 24hrs post surgery
Secondary Outcomes
No secondary outcomes reported
Investigators
Mohammed Faisel H A
Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research