| CTRI Number |
CTRI/2025/07/091949 [Registered on: 29/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Does Melatonin administration before surgery help to reduce pain in post operative period in patients undergoing spine surgery |
|
Scientific Title of Study
|
Effect of preoperative melatonin on postoperative pain in patients undergoing lumbar spine surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amandeep Singh |
| Designation |
Junior resident |
| Affiliation |
Government Medical college and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive care, block d, Level 5,GMCH, sector 32-B,Chandigarh
160030
India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9872470527 |
| Fax |
|
| Email |
bangeramandeepsingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev Palta |
| Designation |
Professor |
| Affiliation |
Government Medical college and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive care, block d, Level 5,GMCH, sector 32-B,Chandigarh
160030
India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121523 |
| Fax |
|
| Email |
sanjeev_palta@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Richa Saroa |
| Designation |
Professor |
| Affiliation |
Government Medical college and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive care, block d, Level 5,GMCH, sector 32-B,Chandigarh
160030
India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121513 |
| Fax |
|
| Email |
richajayant@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive care, block d, Level 5,GMCH, sector 32-B,Chandigarh
160030
India |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Department of Anaethesia and Inetensive care, Block D , Level 5, Government Medical College and Hospital,Sector 32-B ,Chandigarh, India, Pin Code -160030 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amandeep Singh |
Government Medical College and Hospital |
Department of Anaesthesia and Intensive care, block d, Level 5,GMCH, sector 32-B,Chandigarh
160030
India
Chandigarh
CHANDIGARH |
9872470527
bangeramandeepsingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee,GMCH,Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M511||Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Administration of 10 mg
pyridoxine (placebo)tablet 2 hours prior to surgery in
control group |
Patients undergoing lumbar spine surgery (under standard general anaesthesia protocol)will recieve tablet 10mg pyridoxine orally 2 hours prior to surgery once ,
.Post operative VAS at predefined time Intervals . Post operative nausea vomiting score
. Additional intraoperative analgesia requirement
. Time to first rescue analgesia
. Total cumulative fentanyl consumption over 24 hrs in the post-operative period.
. Any side effect pertaining to the medications administered.
total duration is upto 24 hours |
| Intervention |
Administration of 6mg melatonin two hours prior to Surgery in M group |
Patients undergoing lumbar spine surgery (under standard general anaesthesia protocol)will recieve orally tablet 6mg melatonin once 2 hours prior to surgery ,
.Post operative VAS at predefined time Intervals
. Post operative nausea vomiting score
. Additional intraoperative analgesia requirement
. Time to first rescue analgesia
. Total cumulative fentanyl consumption over 24 hrs in the post-operative period.
. Any side effect pertaining to the medications administered.
duration of intervention is upto 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing elective surgery for lumbar spine surgery
2. Age between 18 to 70 years of either sex
3. Patients with American Society of Anaesthesiologists (ASA) physical status class I and II
|
|
| ExclusionCriteria |
| Details |
1. Allergy to the study drug
2. Morbid obesity (BMI more than35 kg/m2)
3. Pregnant women
4. Alcohol Abuse or Opioid Abuse
5. Severe cardiorespiratory, cerebrovascular, renal, hepatic or musculoskeletal diseases
6. Mental Impairment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative VAS at predefined time intervals. |
VAS at rest -immediate post operative period
At 1 hour
At 2 hour
At 4 hour
At 6 hour
At 12 hour
At 24 hour
VAS at Movement-immediate post operative period
At 1 hour
At 2 hour
At 4 hour
At 6 hour
At 12 hour
At 24 hour
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Post operative nausea vomiting score
2. Additional intraoperative analgesia
requirement
3. Time to first rescue analgesia
4. Total cumulative fentanyl consumption
over 24 hrs in the post-operative period.
5. Any side effect pertaining to the medications
administered. |
Immediate post operative period
At 1 hour
At 2 hour
At 4 hour
At 6 hour
At 12 hour
At 24 hour
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
16/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background Postoperative pain is frequently under-treated, impacting recovery, increasing complications, and prolonging hospital stays. Melatonin, a pineal hormone known for regulating circadian rhythms, also exhibits analgesic, anti-inflammatory, antioxidant, and anxiolytic properties. While its role in managing chronic pain and perioperative anxiety is well-established, evidence for its efficacy in acute postoperative pain, especially following spine surgery, remains limited.
Objective To evaluate the effect of preoperative melatonin administration (6 mg orally) on postoperative pain scores in patients undergoing elective lumbar spine surgery under general anesthesia.
Primary Objective
To assess postoperative pain scores (VAS) over a 24-hour period.
Secondary Objectives
Total intraoperative analgesic requirement
Cumulative postoperative fentanyl consumption (via IV PCA) over 24 hours
Time to first rescue analgesia
Incidence of opioid-related side effects (nausea, vomiting)
Patient satisfaction score
Study Design
Type Interventional
Design Prospective, double-blinded, randomized, placebo-controlled trial
Sample Size 50 patients (25 in each group), accounting for potential dropouts
Setting Department of Anaesthesia & Intensive Care, Government Medical College & Hospital, Chandigarh
Inclusion Criteria
Adults aged 18–70 years (ASA I–II) undergoing elective lumbar spine surgery
Exclusion Criteria
Allergies to study drug, morbid obesity, pregnancy, opioid/alcohol abuse, severe systemic illness, or mental impairment
Methodology Patients will be randomized into two groups:
Group M 6 mg oral melatonin 2 hours preoperatively
Group P Matching placebo tablet(10mg pyridoxine) 2 hours preoperatively
Standard anesthesia protocol will be followed. Postoperatively, all patients will receive paracetamol IV and PCA fentanyl. Pain will be measured using the Visual Analogue Scale (VAS) at 1, 2, 3, 6, 12, and 24 hours. Additional data will include total fentanyl consumption, side effects (assessed by Likert scale), and patient satisfaction.
Expected Outcomes This study aims to determine whether preoperative melatonin reduces postoperative pain and opioid requirement without increasing adverse effects, thereby supporting its use in multimodal analgesia for spinal surgeries. |