| 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
|
|
|
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
|
|
|
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. |