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CTRI Number  CTRI/2023/11/059763 [Registered on: 13/11/2023] Trial Registered Prospectively
Last Modified On: 08/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of Melatonin in relieving pain and Quality of Recovery following spine surgery when given preoperatively 
Scientific Title of Study   Effect of Preoperative Melatonin on Postoperative pain relief and Quality of Recovery in patients undergoing spinal fusion surgery: A randomised, triple-blinded, placebo-controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ananya Ray 
Designation  Junior Resident 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Anesthesiology, OT complex, 4th floor, AIIMS Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  8763685767  
Fax    
Email  ray.ananya1998@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aparajita Panda 
Designation  Additional Professor 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Anesthesiology, Room 357, Academic Block, AIIMS Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9438884118  
Fax    
Email  anaes_aparajita@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Aparajita Panda 
Designation  Additional Professor 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Anesthesiology, Room 357, Academic Block, AIIMS Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9438884118  
Fax    
Email  anaes_aparajita@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
Department of Anesthesiology and Critical care, AIIMS Bhubaneswar 
 
Primary Sponsor  
Name  AIIMS Bhubaneswar 
Address  Sijua, Patrapada, Khordha, Odisha, 751019 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ananya Ray  AIIMS Bhubaneswar  Orthopedics ward and OT Complex, 4th floor, AIIMS Bhubaneswar
Khordha
ORISSA 		 8763685767

ray.ananya1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G891||Acute pain, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group M (Melatonin)  Interventional group (Group M) will be given Melatonin 6mg tablet Orally once daily at night 3 days prior to Surgery, 1 hour before surgery and on the night of surgery( total 5 doses )  
Comparator Agent  Group P (Starch tablets)  Placebo group (Group P) will be given starch tablet Orally once daily at night 3 days prior to Surgery, 1 hour before surgery and on the night of surgery( total 5 doses )  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA I & II patients planned for elective spinal fusion surgery (one or two levels) 
 
ExclusionCriteria 
Details  Refusal to give consent, Spinal fusion surgery involving cervical spine and at different sites, Allergy to Melatonin, Pregnancy, BMI > 30kg/m2, Use of narcotic painkillers, gabapentin and tricyclic antipsychotics 72 hours before the intervention, history of any psychiatric disorder, chronic hepatic or renal disorder 
 
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 
Time to request for 1st rescue analgesia in the postoperative period  1st 24 hours after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
VAS Score  1 hour, 6 hour, 12 hour, 24 hour postoperatively 
Total amount of analgesics (Intravenous Tramadol in milligrams)  1st 24 hours postoperatively 
QOR 15 Score  preoperative and 24 hours postoperative 
CRP and IL-6 levels  preoperative and 24 hours postoperative 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   18/11/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Postoperative pain plays a significant role in the recovery of patients as it can lead to patient discomfort and increase the duration of hospital stay. Pain and anxiety positively interact with each other. Opioids and NSAIDs are most commonly used for postoperative pain relief, leading to several undesirable side effects. Earlier studies have demonstrated the analgesic action of Melatonin in various surgeries without unwanted side effects. It also has a role in improving the Quality of Recovery. To the best of our knowledge, no studies have demonstrated the analgesic properties of Melatonin in spinal fusion surgery. So, we hypothesize that Melatonin will be effective in relieving Postoperative pain and Quality of Recovery in spinal fusion surgery. 
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