| CTRI Number |
CTRI/2023/03/050425 [Registered on: 07/03/2023] Trial Registered Prospectively |
| Last Modified On: |
29/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study for assessing technique for pain relief in children undergoing cleft lip surgery. |
|
Scientific Title of Study
|
A double blinded randomised controlled study on the effectiveness of post operative analgesia - comparison between ultrasound versus anatomical landmark technique of blocking bilateral maxillary nerve (suprazygomatic branch) in pediatric patients undergoing cleft lip and palate repair. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SUBASHINI VM |
| Designation |
Postgraduate ( MD Anaesthesiology) |
| Affiliation |
SRM Medical College and Research Institute |
| Address |
No:17/1,
Kamaraj nagar 2nd street,
choolaimedu,
Chennai,
Tamilnadu
Chennai
TAMIL NADU
600094
India |
| Phone |
9566100511 |
| Fax |
|
| Email |
suba1819@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gayathri B |
| Designation |
Head of Department of Anaesthesiology |
| Affiliation |
SRM Institute Of Science and Technology |
| Address |
Room no:209,
B-BLOCK, 2nd floor,
Department of anesthesiology,
SRM Medical college and Research Institute,
Kattankulathur
OT complex,
B-BLOCK, 2nd floor,
Department of anesthesiology,
SRM Medical college and Research Institute,
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9500092905 |
| Fax |
|
| Email |
gayathrii.r@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri B |
| Designation |
Head of Department of Anaesthesiology |
| Affiliation |
SRM Institute Of Science and Technology |
| Address |
Room no:209,
B-BLOCK, 2nd floor,
Department of anesthesiology,
SRM Medical college and Research Institute,
Kattankulathur
Room no:209,
B-BLOCK, 2nd floor,
Department of anesthesiology,
SRM Medical college and Research Institute,
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9500092905 |
| Fax |
|
| Email |
gayathrii.r@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical college and hospital and Research Institution |
|
|
Primary Sponsor
|
| Name |
SRM |
| Address |
ROOM NO:209,
B- BLOCK, 2nd floor,
department of anesthesiology,
SRM medical college and research center,
kattankulathur |
| 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 Subashini VM |
SRM Institute of Science and Technology |
B-206,
B-BLOCK, 2nd floor,
Department of anesthesiology,
SRM Medical college and Research Institute,
Kattankulathur
Kancheepuram
TAMIL NADU |
09566100511
suba1819@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Institutional Ethics Committee- Students |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q375||Cleft hard and soft palate with unilateral cleft lip, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Anatomical Landmark |
Anatomical landmark based Nerve Block |
| Intervention |
Ultrasound |
Ultrasound guided Nerve Block |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing Primary Cleft defect repair.
Aged 6 months to 7 years
Both sexes
Elective Surgeries
|
|
| ExclusionCriteria |
| Details |
ASA III (asthma with marked stridor, asd>5mm, unrepaired VSD, TOF, Eisenmenger syndrome,
bleeding disorder)
infection at the injection site,
allergy to the local anesthetics,
associated syndromes producing facial anomalies,
Parents refusal.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Adequacy for pain relief assessed by FLACC score for postoperative pain. |
2hr, 4hr, 6hr, 8hr, 10hr, 12hr, 14hr, 16hr, 18hr, 20hr, 22hr, 24hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time taken to administer the block
2. The total amount of rescue analgesic requirements during first the 24 h
3. Any complications related to block administration. |
1. Total time in seconds from start of giving the block to end of finishing the block.
2. every 30minutes from end of surgery till first two hours and then every 2 hours till 24 hours
3. measured at the end of 24 hours after surgery. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 4 |
|
Date of First Enrollment (India)
|
01/04/2023 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A total of 70 patients belonging to age group 6months to 7years , ASA class I and II scheduled for cleft palate repair procedures will be prospectively studied. In this double-blinded randomized control trial, a total of 70 participants will be allocated into two groups - GROUP A ( ultrasound guidance) and GROUP B(anatomical landmark technique). Both groups will recieve block with 0.25% Ropivacaine(2mg/kg) with Dexmedetomidine(0.3mcg/kg) with maximal dose of 5ml(on each side) in paediatrics patients undergoing cleft palate repair. All children will be assessed for primary outcomes of postoperative pain (FLACC score) . Data collection will be done by observation and measurement of various parameters.
|