| CTRI Number |
CTRI/2024/03/064239 [Registered on: 15/03/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of long acting pain relieving agents in patients having surgery for gap in upper jaw |
|
Scientific Title of Study
|
Evaluating efficacy of Pre-emptive Tranexamic acid infusion with Ropivacaine to minimise blood loss and post operative pain in children undergoing palatoplasty |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aditya Hurkat |
| Designation |
Post graduate student |
| Affiliation |
Saveetha dental college and hospitals |
| Address |
Department of Oral and Maxillofacial Surgery, Saveetha dental college, Saveetha institute of medical and technical sciences, Poonamallee High Road, Chennai , Tamil Nadu
Chennai
TAMIL NADU
600077
India |
| Phone |
9925012656 |
| Fax |
|
| Email |
aditya.hurkat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod Krishna K |
| Designation |
Associate Professor |
| Affiliation |
Saveetha dental college and hospitals |
| Address |
Department of Oral and Maxillofacial Surgery, Saveetha dental college, Saveetha institute of medical and technical sciences, Poonamallee High Road, Chennai , Tamil Nadu
Chennai
TAMIL NADU
600077
India |
| Phone |
9925012656 |
| Fax |
|
| Email |
vinodkrishna.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditya Hurkat |
| Designation |
Post graduate student |
| Affiliation |
Saveetha dental college and hospitals |
| Address |
Department of Oral and Maxillofacial Surgery, Saveetha dental college, Saveetha institute of medical and technical sciences, Poonamallee High Road, Chennai , Tamil Nadu
Chennai
TAMIL NADU
600077
India |
| Phone |
9925012656 |
| Fax |
|
| Email |
aditya.hurkat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Oral and Maxillofacial Surgery, Saveetha dental college, Saveetha institute of medical and technical sciences, Poonamallee High Road, Chennai , Tamil Nadu |
|
Primary Sponsor
Modification(s)
|
| Name |
Dr Aditya Hurkat |
| Address |
Department of Oral and Maxillofacial Surgery, Saveetha dental college, Saveetha institute of medical and technical sciences, Poonamallee High Road, Chennai , Tamil Nadu |
| 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 Aditya Hurkat |
Saveetha dental college and hospitals, Chennai |
Department of Oral and Maxillofacial Surgery, Saveetha dental college, Saveetha institute of medical and technical sciences, Poonamallee High Road, Chennai , Tamil Nadu
Chennai
TAMIL NADU |
09925012656
aditya.hurkat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College- Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q359||Cleft palate, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lignocaine + Tranexamic acid |
Lignocaine 2& as local infiltration. |
| Intervention |
Ropivacaine+ Tranexamic acid |
Ropivacaine 2% , Local infiltration with maximum dose of 3mg/kg. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Primary cleft palate
Non syndromic patients
No bleeding disorders |
|
| ExclusionCriteria |
| Details |
Palatal fistula
Syndromic patients
Patients with bleeding disorders |
|
|
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 |
| Intraoperative blood loss, Post operative pain |
2,4, 6, 8, 12, 24 Hours |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Surgeons comfort, patients comfort, intra operative vitals |
At 1hour, 6hour, 12hour, & 24 hours post operatively |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
28/03/2024 |
| 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="1"
Months="0"
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
|
To check for blood loss
and to control post operative pain in small children under going repair surgery
of the cleft palate. As it is a long acting anesthetic, the effect will stay
for long time. |