| 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
|
|
|
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
|
|
|
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. |