| CTRI Number |
CTRI/2019/04/018641 [Registered on: 16/04/2019] Trial Registered Prospectively |
| Last Modified On: |
12/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study between the effects two medicines, oral clonidine and pregabalin on pain relief after surgery under spinal anaesthesia. |
|
Scientific Title of Study
|
A comparative study of pre-operative oral clonidine and pregabalin on post-operative analgesia after spinal anaesthesia: A randomised double blind controlled study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Navin Kumar |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
1st Floor, Ward Block
Department of Anaesthesia
Sheikhpura, Bailey Road
Patna
Patna
BIHAR
800014
India |
| Phone |
8210442195 |
| Fax |
|
| Email |
navinnav06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arvind Kumar |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
1st Floor, Ward Block
Department of Anaesthesia
Sheikhpura, Bailey Road
Patna
Patna
BIHAR
800014
India |
| Phone |
9534870908 |
| Fax |
|
| Email |
arvind007kumar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arvind Kumar |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
1st Floor, Ward Block
Department of Anaesthesia
Sheikhpura, Bailey Road
Patna
BIHAR
800014
India |
| Phone |
9534870908 |
| Fax |
|
| Email |
arvind007kumar@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Institute of Medical Sciences |
| Address |
Sheikhpura, Bailey Road
Patna 800014
Bihar |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Navin Kumar |
1st Floor, Ward Block
Department of Anaesthesia
Indira Gandhi Institute of Medical Sciences, Patna 14, Bihar |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Navin Kumar |
Indira Gandhi Institute of Medical Sciences |
1st Floor, Ward Block, Sheikhpura, Bailey Road
Patna, Bihar
Patna
BIHAR |
8210442195
navinnav06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IGIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 3||Administration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Oral Clonidine vs Oral Pregabalin |
To compare effect on post operative analgesia upto 24 hours after surgery |
| Intervention |
Oral Medication of Clonidine and Pregabalin
|
Effect of drugs on postoperative analgesia upto 24 hours after surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I and II
Patients able to comprehend and participate
Patients in whom oral clonidine and pregabalin is indicated for induction analgesia |
|
| ExclusionCriteria |
| Details |
Patients refusal to participate
Contraindications to use of oral clonidine and pregabalin.
Patients with known sensitivity to clonidine and pregabalin
Patients with deranged renal function
Contraindication of spinal anaesthesia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of oral clonidine and pregabalin on post-operative analgesia under spinal anaesthesia |
From administration of drug to upto 24 hours of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of oral clonidine and pregabalin on incidence of hypotension and bradycardia for surgeries under spinal anaesthesia |
From administration of drug to upto 24 hours of surgery |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
17/04/2019 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
We plan to study the effect of oral clonidine and oral pregabalin administered before spinal anaesthesia and to see their effect on post operative analgesia upto 24 hours after surgery. |