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CTRI Number  CTRI/2025/03/083257 [Registered on: 24/03/2025] Trial Registered Prospectively
Last Modified On: 20/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Assessing the after surgical pain reduction by giving one lower dose of Gabapentin 100mg before varicose vein operation. 
Scientific Title of Study   Effectiveness of a Single preoperative low dose of Gabapentin 100mg in reducing postoperative pain in varicose vein surgery. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arul Nirmal Raj S 
Designation  Post Graduate Registrar 
Affiliation  christian medical college vellore 
Address  Arul Nirmal Raj S, Post Graduate, Department of Anesthesiology, Christian Medical College, Vellore, Tamil Nadu, India

Vellore
TAMIL NADU
632004
India 
Phone  9566743370  
Fax    
Email  arulnirmalraj.s@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Tony thomson chandy 
Designation  Professor 
Affiliation  christian medical college, vellore 
Address  department of anaesthesiology, christian medical college, vellore tamilnadu India

Vellore
TAMIL NADU
632004
India 
Phone  9500242412  
Fax    
Email  tonythomson@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  Tony thomson chandy 
Designation  Professor 
Affiliation  christian medical college, vellore 
Address  department of anaesthesiology, christian medical college, vellore tamilnadu India

Vellore
TAMIL NADU
632004
India 
Phone  9500242412  
Fax    
Email  tonythomson@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
Fluid research grant, Christian medical college , Vellore 632004, Tamilnadu, India 
 
Primary Sponsor  
Name  Arul nirmal raj S 
Address  Arul nirmal raj S Department of anaesthesiology, christian medical college, vellore 632004, tamilnadu, India 
Type of Sponsor  Other [self] 
 
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 Arul nirmal Raj S  Christian medical college, Vellore  Division 7 7th floor PB Building Department of anaesthesiology Christian medical college, Vellore 632004 Tamilnadu, India
Vellore
TAMIL NADU 
9566743370

arulnirmalrajs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board and Ethics Commitee of CMC Vellore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I832||Varicose veins of lower extremities with both ulcer and inflammation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Oral Gabapentine Suspension group  Oral Suspension Gabapentine 100mg Single dose 2hrs prior to surgery 
Comparator Agent  Placebo group  Oral Placebo drug is composition of Carboxymethyl cellulose and syrup NF 2 hrs prior to surgery  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  a) All ASA 1 and 2 patients for varicose vein surgery
b) Age between 18 to 60 years
 
 
ExclusionCriteria 
Details  a)Patient refusal
b)ASA more than 3 patient
c)Ideal body weight less than 50 kg
d)Allergic to Gabapentin
e)Patient on antiepileptics
f)Contraindication to opioids and paracetamol
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
comparison of post operative pain in patients taking single pre op dose of gabapentin and preop placebo  will be assessed at 4hrs after giving spinal anaesthesia then every 1hrs for first 24 hrs. 
 
Secondary Outcome  
Outcome  TimePoints 
a.To measure the Sedation using Ramsay sedation scale in the postoperative period
b.To calculate the total requirements of analgesia used in first 24 hours postoperatively.
c.To measure the incidence of nausea and vomiting
 
First 24 hrs of postop period 
 
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 3 
Date of First Enrollment (India)   01/04/2025 
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  

Minimally invasive Varicose veins surgery is a standard of care for dilated incompetent leg veins.  However, patients often have a low-grade postoperative pain which leads to poor patient satisfaction.

Gabapentin, an NMDA receptor modulator, has been used to modulate postoperative pain as a preemptive agent. The study is designed as a randomized control trial to evaluate prevention of postoperative pain with gabapentin.

Patients undergoing varicose vein surgery who fulfill the inclusion criteria will be enrolled in the study. Pre operative pain score will be evaluated using Numeric Rate Score. Patients will be divided into two groups by random allocation.

 

Group A will receive 100 mg of Gabapentin Suspension 2 hours prior to surgery.

 

Group B will receive a placebo 2 hours prior to surgery.

 

All patients will undergo surgery under spinal anesthesia. They will receive 0.5% heavy Bupivacaine (Hyperbaric) with 25mcg Fentanyl.

After surgery, patients will be assessed for post operative incidence of pain using Numeric Rate Score, sedation with Ramsay sedation score and post operative nausea and vomiting at regular intervals for first 24 hours.

Post operatively all patients will receive Tablet Paracetamol 1gm per oral every 6hrly. Break through pain will be managed with subcutaneous Inj. Morphine 0.1mg/kg for the first 24 hrs.

 
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