| CTRI Number |
CTRI/2021/01/030736 [Registered on: 25/01/2021] Trial Registered Prospectively |
| Last Modified On: |
19/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of pregabalin given pre-operatively in patients undergoing total abdominal hysterectomy under spinal anaesthesia |
|
Scientific Title of Study
|
Role of pregabalin as pre-emptive analgesic in patients undergoing total abdominal hysterectomy under spinal anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Narendra Babu MC |
| Designation |
Professor and head of the department. Department of anaesthesiology |
| Affiliation |
Kempegowda institute of medical sciences, Bengaluru |
| Address |
Department of Anesthesiology, A-block, 4th floor,Kempegowda institute of medical sciences, Bengaluru 560004
Bangalore
KARNATAKA
560004
India |
| Phone |
9900214064 |
| Fax |
|
| Email |
narendrababuchanappa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narendra Babu MC |
| Designation |
Professor and head of the department. Department of anaesthesiology |
| Affiliation |
Kempegowda institute of medical sciences, Bengaluru |
| Address |
Department of Anesthesiology, A-block,4tg floor, Kempegowda institute of medical sciences, Bengaluru 560004
Bangalore
KARNATAKA
560004
India |
| Phone |
9900214064 |
| Fax |
|
| Email |
narendrababuchanappa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sania Almeida |
| Designation |
Post graduate |
| Affiliation |
Kempegowda institute of medical science, Bengaluru |
| Address |
Department of Anesthesiology, A-block, 4th floor, Kempegowda institute of medical sciences, Bengaluru 560004
Bangalore
KARNATAKA
560004
India |
| Phone |
7276737209 |
| Fax |
|
| Email |
almeidasania@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sania Almeida
Kempegowda institute of medical science, Bengaluru |
|
|
Primary Sponsor
|
| Name |
Dr Sania Almeida |
| Address |
Post graduate, Department of anesthesiology, Kims, Bengaluru |
| 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 Sania Almeida |
Kempegowda institute of medical science, bengaluru |
Department of anesthesiology, Kempegowda institute of medical science, Bengaluru
Bangalore
KARNATAKA |
7276737209
almeidasania@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kims institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O9A1||Malignant neoplasm complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pregabalin |
Role of pregabalin as preoperative analgesic to assess the post operative requirement of analgesia
Pregabalin 150mg iv preoperatively once , 1hour before surgery |
| Intervention |
Pregabalin 150mg iv preoperatively once , 1hour before surgery |
role of pregabalin in post operative pain and analgesic requirement
Pregabalin 150mg iv preoperatively once , 1hour before surgery |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
ASA grade 1 and 2
Patients undergoing Total abdominal hysterectomy |
|
| ExclusionCriteria |
| Details |
Allergy to pregabalin
patient on antiplatlet and anticoagulants
consumption of Nsaids in last 48hours
Coagulation abnormalities |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in requirement of post operative analgesia |
Reduction in requirement of post operative analgesia
VAS score to be assessed at 2,4,8,12and 24hrs post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/01/2021 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To evaluate whether pregabalin when given preoperatively has an effect on postoperative pain and analgesic requirement. Purpose of the trial is to reduce requirement of opioid consumption postoperatively |