| CTRI Number |
CTRI/2024/06/068288 [Registered on: 04/06/2024] Trial Registered Prospectively |
| Last Modified On: |
16/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Tablet Melatonin on pain in patients undergoing Lower limb surgery |
|
Scientific Title of Study
|
Effect of Melatonin On Pain In Patients Undergoing Lower Limb Surgery: A Randomized Open Label study- PG Dissertation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohammed Faisel H A |
| Designation |
Post Graduate, Pharmacology |
| Affiliation |
Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
Department of Pharmacology, Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research, Tamaka, Kolar
Kolar
KARNATAKA
563103
India |
| Phone |
7795849618 |
| Fax |
|
| Email |
drmdfaisel618@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhuvana K |
| Designation |
Professor, Pharmacology |
| Affiliation |
Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
Department of Pharmacology, Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research, Tamaka, Kolar
Kolar
KARNATAKA
563103
India |
| Phone |
9900383738 |
| Fax |
|
| Email |
drbhuvanak2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhuvana K |
| Designation |
Professor, Pharmacology |
| Affiliation |
Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
Department of Pharmacology, Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research, Tamaka, Kolar
Kolar
KARNATAKA
563103
India |
| Phone |
9900383738 |
| Fax |
|
| Email |
drbhuvanak2010@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research, Tamaka, kolar, karnataka, India. Pincode-
563103 |
|
|
Primary Sponsor
|
| Name |
Mohammed faisel h a |
| Address |
post graduate, department of pharmacology, sri devaraj urs medical college, tamaka, kolar, 563101 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohammed Faisel H A |
R L Jalappa Hospital and Research Centre, Sri Devaraj Urs Medical College |
Post Operative ward, Second floor
Kolar
KARNATAKA |
7795849618
drmdfaisel618@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Ethics Committee, Sri Devaraj Urs Academy of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection Diclofenac 50mg Intramuscular |
After surgery, participants in the control group will receive only injection diclofenac 50mg by intramuscular route twice daily for 5 days, both in the morning and at night. |
| Intervention |
Injection Diclofenac 50mg Intramuscular and oral Tablet Melatonin 5mg |
After surgery, participants in the Melatonin group will receive injection diclofenac 50mg by intramuscular route twice daily for 5 days, both in the morning and at night. In addition tablet Melatonin 5mg will be administered orally with sip of water 60 minutes before the surgery, at 9pm on the day of surgery and for the following five post operative days. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
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 scale |
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 Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/06/2024 |
| Date of Study Completion (India) |
31/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/10/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drmdfaisel618@gmail.com].
- For how long will this data be available start date provided 01-01-2027 and end date provided 01-01-2029?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
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: 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 scale |