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CTRI Number  CTRI/2022/09/045705 [Registered on: 20/09/2022] Trial Registered Prospectively
Last Modified On: 29/04/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Opioid versus alternative drug for pain management during brain surgery  
Scientific Title of Study   Non-opioid versus Opioid Perioperative Analgesia In Neurosurgery: A prospective Multi-centric Randomized Controlled Trial (NO PAIN Trial) 
Trial Acronym  NOPAIN 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sriganesh Kamath 
Designation  Professor 
Affiliation  National Institute of Mental Health and Neurosciences, Bengaluru 
Address  Department of Neuroanaesthesia and Neurocritical Care, NIMHANS, Bengaluru
Hosur Road, Bengaluru, Karnataka
Bangalore
KARNATAKA
560029
India 
Phone  08026995415  
Fax    
Email  drsri23@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sriganesh Kamath 
Designation  Professor 
Affiliation  National Institute of Mental Health and Neurosciences, Bengaluru 
Address  Department of Neuroanaesthesia and Neurocritical Care, NIMHANS, Bengaluru
Hosur Road, Bengaluru, Karnataka

KARNATAKA
560029
India 
Phone  08026995415  
Fax    
Email  drsri23@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sriganesh Kamath 
Designation  Professor 
Affiliation  National Institute of Mental Health and Neurosciences, Bengaluru 
Address  Department of Neuroanaesthesia and Neurocritical Care, NIMHANS, Bengaluru
Hosur Road, Bengaluru, Karnataka

KARNATAKA
560029
India 
Phone  08026995415  
Fax    
Email  drsri23@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research (ICMR), New Delhi 
 
Primary Sponsor  
Name  Sriganesh Kamath 
Address  Department of Neuroanaesthesia and Neurocritical Care, NIMHANS Bengaluru 560029 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Georgene Singh  Christian Medical College, Vellore  Christian Medical College, Ida Scudder Road, Vellore - 632004 Tamil Nadu, India
Vellore
TAMIL NADU 		 9443292504

georgenesingh@gmail.com 
Dr Prasanna Bidkar  Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER)  Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Dhanvantari Nagar, Puducherry, 605006
Pondicherry
PONDICHERRY 		 9442706168

drprasannabidkar@gmail.com 
Dr Sriganesh Kamath  National Institute of Mental Health and Neurosciences (NIMHANS), Bengaluru  National Institute of Mental Health and Neurosciences (NIMHANS), Hosur Road, Bengaluru 560029
Bangalore
KARNATAKA 		 9481445949

drsri23@gmail.com 
Dr Srilata   Nizams Institute of Medical Sciences (NIMS), Hyderabad  Nizams Institute of Medical Sciences, Punjagutta, Hyderabad, Telangana, India 500082
Hyderabad
TELANGANA 		 9848352882

srilatanims@gmail.com 
Dr Manikandan S  Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Trivandrum  Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Thiruvananthapuram - 695 011, Kerala, India.
Thiruvananthapuram
KERALA 		 9446334711

kanmanisethu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
CMC Ethics Committee  Approved 
JIPMER Ethics Committee  Approved 
NIMHANS Ethics Committee  Approved 
NIMS Ethics Committee  Approved 
SCTIMST Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine  Dexmedetomidine 0.5 mcg/kg/h will be administered as continuous infusion after anesthetic induction till end of surgery. 
Comparator Agent  Fentanyl  Fentanyl will be administered as 1 mcg/kg/h as continuous infusion after anesthetic induction till the end of surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All consecutive consenting adult patients undergoing elective craniotomies for supratentorial brain tumors with Glasgow Coma Scale score of 15 will be included in this trial.  
 
ExclusionCriteria 
Details  We will exclude patients from this trial if they do not consent or if they have a current or past history of ischemic heart disease, cardiac failure (New York Heart Association grade ≥ 3), heart block or arrhythmia, untreated hypertension and diabetes mellitus, emergency surgery, pre-existing pain and receiving regular long-term drugs to manage pain, history of vomiting, previous cranial surgery, allergy to study drugs and opioid dependence as per the Diagnostic and Statistical Manual of mental disorders IV criteria.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Rescue fentanyl consumption during surgery
2. Postoperative pain using Numerical Rating Scale score
 		 1. During surgery
2. After surgery
 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse events  During and upto 60 minutes after surgery 
Quality of recovery from anesthesia and emergence delirium   End of anesthesia till 60 minutes after surgery 
Patient satisfaction   24 hours after surgery  
Quality of sleep   1st postoperative day 
Persistent pain and quality of life   At 3 and 6 months after surgery  
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   20/09/2022 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response (Others) -  Subject to approval of funding agency and IEC approvals from all centers

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. 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.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drsri23@gmail.com].

  6. For how long will this data be available start date provided 31-12-2024 and end date provided 31-12-2026?
    Response (Others) -  24 months after publication

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Opioids are associated with unwanted adverse effects. Prolonged, overuse of opioid is a major public health problem across the world. In the healthcare setting, maximal opioid usage occurs during surgery and pain management. To overcome opioid-associated complications, alternatives to opioids are explored. Dexmedetomidine when added to opioid reduces the adverse effects and anesthetic and opioid consumption in neurosurgical patients. Our pilot study showed non-inferiority of dexmedetomidine (as primary non-opioid analgesic) to fentanyl (opioid analgesic) for perioperative pain management in neurosurgery. Hence, we intend to conduct this larger trial to confirm our preliminary findings. This will provide an effective and safe alternative to opioids for perioperative pain management.

 
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