| CTRI Number |
CTRI/2024/04/066219 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
22/04/2024 |
| 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
|
Comparison of Post-surgery versus Pre-surgery caudal nerve block on surgical outcomes in children undergoing hypospadias surgery |
|
Scientific Title of Study
|
Comparison of Post-surgical versus Pre-surgical caudal block on surgical outcomes in children undergoing hypospadias repair:A Randomised Controlled Trial |
| 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 Osharani Rathor |
| Designation |
Post graduate student |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Department of Anaesthesiology, Builiding A, Floor 6, AIIMS Rishikesh Virbhadra road Rishikesh Uttarakhand 249203 India
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8594922622 |
| Fax |
|
| Email |
rathorlipsa.123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mridul Dhar |
| Designation |
Associate professor |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Department of Anaesthesiology, Builiding A, Floor 6, AIIMS Rishikesh Virbhadra road Rishikesh Uttarakhand 249203 India
Department of Anaesthesiology, Builiding A, Floor 6, AIIMS Rishikesh Virbhadra road Rishikesh Uttarakhand 249203 India
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9717778374 |
| Fax |
|
| Email |
mriduldhar8@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Osharani Rathor |
| Designation |
Post graduate student |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Department of Anaesthesiology, Builiding A, Floor 6, AIIMS Rishikesh Virbhadra road Rishikesh Uttarakhand 249203 India
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8594922622 |
| Fax |
|
| Email |
rathorlipsa.123@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Science ,Rishikesh |
|
|
Primary Sponsor
|
| Name |
AIIMS Rishikesh, Uttrakhand |
| Address |
AIIMS Rishikesh Virbhadra road Rishikesh Uttarakhand 249203 India |
| 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 Mridul Dhar |
AIIMS Rishikesh |
Department of Anaesthesiology, Builiding A, Floor 6, AIIMS Rishikesh Virbhadra road Rishikesh Uttarakhand 249203 India
Dehradun
UTTARANCHAL |
9717778374
mriduldhar@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Post-surgical caudal block |
Caudal block given at end of surgery, before awakening. 0.2% Ropivacaine (1ml/kg)
|
| Comparator Agent |
Pre-surgical caudal block |
Conventional caudal block given before incision, after induction of anesthesia using 0.2% ropivacaine (1ml/kg) |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Male |
| Details |
Male child:Aged 1-8 years
ASA I and II
children undergoing hypospadias repair surgery
|
|
| ExclusionCriteria |
| Details |
skin infection or abscess at the side of caudal injection
parents disagreement / refusal to consent
patients having coagulopathy / on anticoagulants
known allergy to any local anaesthetics
children with neuromuscular disorders
spinal dysraphism(meningomyelocele/sacral dimples)
mental retardation/delayed development
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Overall incidence of the following surgical complications: Urethro-cutaneous fistula, Local skin necrosis, Wound infection, Hematoma, Glans dehiscence and urethral stricture |
Post operative: Day 5, Day 10, 1 month and 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intra-operative blood loss |
At the end of surgery |
| Intra-operative increase in penile volume |
0,10,15 & 30 minutes post induction of anesthesia |
| Surgical stress response [blood glucose, by point of care glucometer] |
0,30,60 & 90 minutes post induction |
| Surgery duration |
End of surgery |
| Surgery revision rate (requirement of re-surgery) |
Ascertained at 1 & 6 months post operative |
| Duration of post-operative analgesia |
Post operative, the time to first rescue analgesic requirement at a FLACC score more than 5 or Visual Analogue Score corresponding to Numerical rating scale of more than 5 (in older children). |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/05/2025 |
| 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="9"
Days="6" |
|
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
|
The Aim of the study is to compare the effect of post-surgical versus pre-surgical caudal blocks on surgical complications in children undergoing hypospadias repair surgery.Patient included are all ASA1 and ASA II ages 1 to 8 years. After approval from institutional ethics committee and obtaining written informed consent patient included in the study will be randomised to receive caudal blocks. There will be 2 groups one group will be receiving caudal blocks post-surgically and will be compared to the groups receiving caudal blocks pre-surgically.Primary surgical outcomes and complications, and secondary anaesthetic peri-operative outcomes will be measured. |