Effect of Tablet Melatonin on pain in patients undergoing Lower limb surgery

Effect of Melatonin On Pain In Patients Undergoing Lower Limb Surgery: A Randomized Open Label study- PG Dissertation - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/068288

Enrollment

Registered

2024-06-04

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M968- Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified

Interventions

Intervention1: Injection Diclofenac 50mg Intramuscular and oral Tablet Melatonin 5mg: After surgery, participants in the Melatonin group will receive injection diclofenac 50mg by intramuscular route t

Eligibility

Inclusion criteria

Inclusion criteria: 1)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

Exclusion criteria: 1)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

Design outcomes

Primary

Measure	Time frame
1) To assess the effect of Melatonin on post operative pain relief in patients undergoing lower limb orthopedic surgery using Visual Analog Scale 2) To study the effect of melatonin on peri-operative anxiety using Visual Analog Scale for Anxiety (VAS-A) 3) To evaluate the safety profile of melatonin using WHO causality scaleTimepoint: 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	—

Measure

Time frame

1) To assess the effect of Melatonin on post operative pain relief in patients undergoing lower limb orthopedic surgery using Visual Analog Scale 2) To study the effect of melatonin on peri-operative anxiety using Visual Analog Scale for Anxiety (VAS-A) 3) To evaluate the safety profile of melatonin using WHO causality scaleTimepoint: 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

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactBhuvana K

Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research

drbhuvanak2010@gmail.com9900383738

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026