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CTRI Number  CTRI/2024/09/073892 [Registered on: 13/09/2024] Trial Registered Prospectively
Last Modified On: 13/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   A comparative study between oral gabapentin and oral pregabalin in acute post-operative pain management in patients undergoing urological procedures under sub-arachnoid block. 
Scientific Title of Study   A comparative study of oral gabapentin versus oral pregabalin in acute post-operative pain management in patients undergoing urological procedures under sub-arachnoid block. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kavyashree M Arun 
Designation  Post graduate  
Affiliation  Sapthagiri Institute of Medical Sciences and Research Centre 
Address  Department of ANaesthesiology Sapthagiri Institute of Medical Sciences and Research Institute Navy Layout, Hesaraghatta main road, Chikkabanavara, Bangalore

Bangalore
KARNATAKA
560090
India 
Phone  9945840092  
Fax    
Email  kavya.marun@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Narendra Babu C 
Designation  Professor 
Affiliation  Sapthagiri Institute of Medical Sciences and Research Institute 
Address  Department of ANaesthesiology Sapthagiri Institute of Medical Sciences and Research Institute Navy Layout, Hesaraghatta main road, Chikkabanavara, Bangalore

Bangalore
KARNATAKA
560090
India 
Phone  9900214064  
Fax    
Email  narendrababuchanappa@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Narendra Babu C 
Designation  Professor 
Affiliation  Sapthagiri Institute of Medical Sciences and Research Institute 
Address  Department of ANaesthesiology Sapthagiri Institute of Medical Sciences and Research Institute Navy Layout, Hesaraghatta main road, Chikkabanavara, Bangalore


KARNATAKA
560090
India 
Phone  9900214064  
Fax    
Email  narendrababuchanappa@gmail.com  
 
Source of Monetary or Material Support  
Sapthagiri Institute of Medical Sciences and Research Institute, Chikkabanavara, Hesaraghatta Main Road, Bangalore - 560090 
 
Primary Sponsor  
Name  Sapthagiri Institute of Medical Sciences and Research Institute 
Address  Department of Anaesthesiology Sapthagiri Institute of Medical Sciences and Research Institute Navy Layout, Hesaraghatta main road, Chikkabanavara, Bangalore  
Type of Sponsor  Private medical college 
 
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 Narendra Babu C  Sapthagiri Institute of Medical Sciences and Research Institute   Department of Anaesthesiology Sapthagiri Institute of Medical Sciences and Research Institute Navy Layout, Hesaraghatta main road, Chikkabanavara, Bangalore
Bangalore
KARNATAKA 
9900214064

narendrababuchannappa@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sapthagiri Institute of Medical Sciences   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N29||Other disorders of kidney and ureter in diseases classified elsewhere, (2) ICD-10 Condition: N288||Other specified disorders of kidney and ureter,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Adminstration of Gabapentin  Administration of T. Gabapentin 600 mg orally 1 hour before administration of anaesthesia  
Comparator Agent  Adminstration of Pregabalin   Administration of T. Pregabalin 150mg orally 1 hour before administration of anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients willing to give written informed consent.
2. Patients undergoing urological procedure.
3. ASA grade - 1&2 
 
ExclusionCriteria 
Details  1. ASA Grade - 3 & above.
2. Patients with known allergy to pregabalin, history of intake of NSAIDs within 48 hours of surgery, coagulation abnormalities.
3. Patients on anti-coagulant and anti-platelet medications. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
VAS score  VAS score assessed at baseline, 2, 4, 6 and 12 hours after procedure. 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
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   N/A 
Date of First Enrollment (India)   30/09/2024 
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="0"
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  

After obtaining approval and clearance from the institutional ethics committee, the patients fulfilling the inclusion criteria will be enrolled for the study after obtaining informed consent.

Demographic details of the patients will be recorded as per the case record form.

After a thorough pre-operative evaluation, visual analogue score (VAS) is explained to the patient. On the day of surgery, two hours prior to the procedure, patients are pre-medicated with Tab. Pantoprazole 40mg. Patients are randomly allocated into two groups based on computer generated random number table. The patients are unaware as to which group they belong.

Group A receive T.  Pregabalin 150mg and Group B receive T. Gabapentin 600mg. After shifting the patient to operating room, sub-arachnoid block is given with Inj. Bupivacaine heavy (0.5%) at a dose of 0.3mg/kg body weight with maximum dose limited to 20mg and the level was assessed.After surgery, all the patients received IV Paracetamol 1 gram and are shifted to the recovery room. All patients are given Inj. Tramadol 50mg as rescue analgesia, once VAS exceeds 4. The patients are subsequently shifted to ward. Post-operatively VAS score is assessed at 0,2,4,6 and 12 hours after surgery. Total amount of analgesic administered is recorded. Any adverse events like giddiness, nausea, vomiting in the first 24 hours of post-operative period is noted.

 
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