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CTRI Number  CTRI/2023/08/056640 [Registered on: 18/08/2023] Trial Registered Prospectively
Last Modified On: 17/08/2023
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 giving oral Pre-emptive Gabapentin for post operative pain relief to patients undergoing surgery under general anesthesia  
Scientific Title of Study   Efficacy of Oral Pre-emptive Gabapentin for post-operative pain relief in patients undergoing surgery under General Anaesthesia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Cheeranjeevi S 
Designation  Post graduate 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Department of Anesthesiology Pondicherry Institute of Medical Sciences, Ganapathichettikulam, Kalapet, Puducherry-605014

Pondicherry
PONDICHERRY
605014
India 
Phone  9597717108  
Fax    
Email  cheeranjeevi97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ramyavel 
Designation  Professor 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Department of Anaesthesiology, Pondicherry Institute of Medical Sciences,Puducherry

Pondicherry
PONDICHERRY
605014
India 
Phone  9487630425  
Fax    
Email  ramyavel1988@gmail.com  
 
Details of Contact Person
Public Query  
Name  Cheeranjeevi S 
Designation  Post Graduate 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Department of Anaesthesiology, Pondicherry Institute of Medical Sciences,Puducherry

Pondicherry
PONDICHERRY
605014
India 
Phone  9597717108  
Fax    
Email  cheeranjeevi97@gmail.com  
 
Source of Monetary or Material Support  
Pondicherry Institute of Medical Sciences 
 
Primary Sponsor  
Name  Pondicherry Institute of Medical Sciences 
Address  Pondicherry Institute of Medical Sciences, Ganapathichettikullam, Puducherry-605014 
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 Cheeranjeevi S  Pondicherry Institute of Medical Sciences  Department of Anaesthesiology, Pondicherry Institute of Medical Sciences,Ganapathichettikullam,Pondicherry
Pondicherry
PONDICHERRY 		 9597717108

cheeranjeevi97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PIMS Institute 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 
Comparator Agent  Placebo tablets  Identical capsules as placebo will be administered orally at same two occasions, one at prior night and other at morning approximately 2 hours prior to shifting to OT for surgery.  
Intervention  Tablet Gabapentin  oral gabapentin 600mg will be pre-medicated at two occasions, one at prior night & other at morning approximately 2 hours prior to shifting to OT for surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1-Patients belonging to American Society of Anesthesiologist physical status
classification I & II.
2-Patients aged between 18-65 years.
3-Patients scheduled for elective General Anesthesia procedures 
 
ExclusionCriteria 
Details  1-Patients undergoing Emergency surgical procedures.
2-Patients undergoing Surgeries under combined Regional/ Nerve blocks and
General anesthesia
3-Patients undergoing laparoscopic surgeries.
4-Patients with history of chronic pain/prolonged pain medications.
5-Pregnant patients.
6-Patients with history of Psychiatric disease/ Drug abuse.
7-Patients with BMI > 40kg/m2.
8-Patients with history of use of anti-convulsant. 
 
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 
To measure the efficacy of oral pre-emptive gabapentin in reducing post-operative
pain when compared to placebo in patients undergoing surgery under general
anaesthesia. 		 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1) Post operative total analgesic consumption for 24 hrs.
2) Pre-operative anxiety between two groups.
3) Intra-operative & post-operative hemodynamic changes (Heart rate, Mean arterial
pressure) between two groups.
4) Post operative sedation level between two groups 		 24 hours 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   28/08/2023 
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="2"
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   To measure the effect of oral gabapentin in reducing post-operative pain in patients undergoing surgery under general anesthesia. This study also helps in assessing the reduction of anxiety prior to surgery, proper post-operative sedation and reduction in the use of dosages of post-operative analgesia being used than normal time.  
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