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CTRI Number  CTRI/2024/10/075181 [Registered on: 14/10/2024] Trial Registered Prospectively
Last Modified On: 11/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To study the correlation between preoperative pregabalin premedication and its perioperative opioid sparing effects in brain tumour patients undergoing craniotomies. 
Scientific Title of Study   Effects of pregabalin on perioperative opioid-sparing effects on patients undergoing craniotomies for brain tumors. A Randomized, double-blinded, placebo controlled study. 
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 Sai Saravanan K 
Designation  Post Graduate - Junior Resident 
Affiliation  AIIMS, RAIPUR 
Address  Department of Anaesthesiology, AIIMS Raipur Raipur CHHATTISGARH India

Raipur
CHHATTISGARH
492099
India 
Phone  9597140794  
Fax    
Email  saikicha98@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Monica Malhotra 
Designation  Professor 
Affiliation  AIIMS, RAIPUR 
Address  Department of Anaesthesiology, AIIMS Raipur Raipur CHHATTISGARH India

Raipur
CHHATTISGARH
492099
India 
Phone  8518881714  
Fax    
Email  monicakhetrapal@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Monica Malhotra 
Designation  Professor 
Affiliation  AIIMS, RAIPUR 
Address  Department of Anaesthesiology, AIIMS Raipur Raipur CHHATTISGARH India

Raipur
CHHATTISGARH
492099
India 
Phone  8518881714  
Fax    
Email  monicakhetrapal@yahoo.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Tatibandh,GE Road ,Raipur Chattisgarh 492099 INDIA 
 
Primary Sponsor  
Name  Nil 
Address  nil 
Type of Sponsor  Other [Nil] 
 
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 Sai Saravanan K  AIIMS, RAIPUR  Department of Anaesthesiology, Neurosurgery OT, Superspeciality OT Complex 4th Floor, B block
Raipur
CHHATTISGARH 		 9597140794

saikicha98@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS Raipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D332||Benign neoplasm of brain, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  placebo/vitamin capsules  Given on night before and morning 2 hours before surgery with sips of water 
Intervention  Pregabalin   150 mg each Given on night before and morning 2 hours before surgery with sips of water 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Patients of either gender
2) Age 18–65 years
3) ASA class I, II
4) Patients with GCS 15
5) Scheduled for elective craniotomies for excision of brain tumors 
 
ExclusionCriteria 
Details  1)Allergy to study drugs and opioid dependence.
2)Patients undergoing emergency surgery.
3)Patients receiving chronic neuroleptics, tricyclic antidepressants, serotonin noradrenaline
reuptake inhibitors 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
a]Total intra-operative opioid consumption
b] Post-operative pain scores and rescue analgesia.  		 a]Till 12 hours postoperative
b]Till 12 hours postoperative 
 
Secondary Outcome  
Outcome  TimePoints 
a] Incidence of adverse effects of opioids like PONV, shivering.
b] Incidence of emergence delirium and delayed recovery.  		 a]Till 12 hours postoperative 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 2 
Date of First Enrollment (India)   22/10/2024 
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 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   • A craniotomy is a neurosurgical procedure done to get a wide cranial opening for doing surgical therapeutic maneuvers. Posi-craniotomy pain is a common entity. Pain can elicit a complex set of neural, and cardiac. and respiratory changes, leading to increased cerebral blood flow and intracranial pressure, cerebral edema, and even intracranial bleeding operative analgesics. Traditionally, opioids are being used in craniotomy cases for induction, intraoperative pain management, and post• operative pain management. Opioids are potent analgesics but their usage can interfere with neurological monitoring and are associated with serious side effects like PONV, constipation, pruritis, sedation, opioid-induced hyperalgesia (OIH), and life-threatening respiratory depression.  Pregabalin has been evaluated for postoperative analgesia in orthopedic and spine surgeries, laparoscopic hysterectomy, laparoscopic cholecystectomy, and thoracotomy, etc., Preemptive use of gabapentinoids is also known to effectively reduce opioid consumption There is a deficiency of trials investigating its effects in attenuating perioperative pain in intracranial surgeries. This study was designed to evaluate the opioid-sparing effect of preoperative pregabalin in patients undergoing craniotomy for brain tumors Studies of pregabalin in neurosurgical patients are scarce. There are only a few published randomized studies of pregabalin use for analgesia in patients undergoing craniotomy and these limited studies compare pre-emptive pregabalin and gabapentin and their opioid-sparing effects. However, these studies have some drawbacks like using sub-therapeutic doses of pregabalin, non-consideration of opioid side effects, and prolonged postoperative use of pregabalin, which we would like to correct in our study. 
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