| CTRI Number |
CTRI/2024/10/076057 [Registered on: 29/10/2024] Trial Registered Prospectively |
| Last Modified On: |
29/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Determining the best needle length in young children using ultrasound |
|
Scientific Title of Study
|
Determination of the optimal needle length for caudal block in infants using ultrasonography |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya Jain |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Anesthesia, fourth floor, Nehru hospital, PGIMER, sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855900171 |
| Fax |
|
| Email |
jaindivya77@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shephali |
| Designation |
Senior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Anesthesia, fourth floor, Nehru hospital, PGIMER, sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9044657889 |
| Fax |
|
| Email |
addusingh22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shephali |
| Designation |
Senior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Anesthesia, fourth floor, Nehru hospital, PGIMER, sector 12, Chandigarh
CHANDIGARH
160012
India |
| Phone |
9044657889 |
| Fax |
|
| Email |
addusingh22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research, sector-12, Madhya marg, Chandigarh, India- 160012 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education and Research |
| Address |
SECTOR 12, MADHYA MARG, CHANDIGARH, INDIA-160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shephali |
Advance pediatric centre, Post Graduate Institute of Medical Education and Research |
Pediatric surgery operation theatre, 6th floor (6A), OT number 1-4, Divison of pediatric anesthesia, Deartment of Anesthesia
Chandigarh
CHANDIGARH |
9044657889
addusingh22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Intramural), Postgraduate Institute of Medical Education and Research, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K928||Other specified diseases of the digestive system, (2) ICD-10 Condition: N398||Other specified disorders of urinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
1.00 Year(s) |
| Gender |
Both |
| Details |
Infant (1 month-1 year) undergoing surgery in APC OT under general anaesthesia and caudal block |
|
| ExclusionCriteria |
| Details |
Parental refusal to participate in the study.
Contra-indication to caudal block (local site infection, coagulopathy, raised intracranial pressure, vertebral anomalies)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the optimal needle length for caudal block in infants using ultrasonography |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the factors (age, gender, weight, height, weight to height ratio, body mass index & subcutaneous fat in sacral area) that affect the optimal needle length. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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)
|
10/11/2024 |
| 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
|
Caudal block is the primary and most widely employed regional anesthesia technique in pediatric population. Irrespective of its high success rate, there is increased risk of dural and vascular puncture due to inappropriate needle length inserted to place the block. Ultrasound guided caudal needle insertion is recommended for each patient. However, there is lack of USG in many centers, making scanning impossible. The distance that a needle can be safely inserted while performing a caudal block in infants would be a useful information for anesthesiologist in clinical practice. There is no known standard method at present which suggest the optimal length of needle which can be used to perform caudal block, by avoiding risk of dural puncture. Therefore, the present study is designed to determine the optimal needle length for caudal block using ultrasound and identify the factors that affects the needle length for caudal block in infants. |