| CTRI Number |
CTRI/2024/03/064112 [Registered on: 14/03/2024] Trial Registered Prospectively |
| Last Modified On: |
13/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare dorsal penile block vs caudal epidural block for hypospadias surgery by ultrasound.
|
|
Scientific Title of Study
|
Comparison of Ultrasound guided Dorsal penile block and Ultrasound guided
caudal epidural block for postoperative analgesia in children undergoing hypospadias surgery:A
randomized control study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Snigdha Kumari |
| Designation |
Senior resident |
| Affiliation |
AIIMS Raipur |
| Address |
B block,4th floor,superspeciality ot complex,AIIMS Raipur.
Raipur
CHHATTISGARH
492009
India |
| Phone |
7909059807 |
| Fax |
|
| Email |
snigdhasingh19590@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Snigdha Kumari |
| Designation |
Senior resident |
| Affiliation |
AIIMS Raipur |
| Address |
B block,4th floor, superspeciality ot,AIIMS Raipur.
Raipur
CHHATTISGARH
492009
India |
| Phone |
7909059807 |
| Fax |
|
| Email |
snigdhasingh19590@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Snigdha Kumari |
| Designation |
Senior resident |
| Affiliation |
AIIMS Raipur |
| Address |
4th floor,B block, superspeciality ot,AIIMS Raipur.
Raipur
CHHATTISGARH
492009
India |
| Phone |
7909059807 |
| Fax |
|
| Email |
snigdhasingh19590@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| DrSnigdha Kumari |
AIIMS Raipur |
4th floor, superspeciality
ot,AIIMS Raipur
Raipur
CHHATTISGARH |
7909059807
snigdhasingh19590@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Commitee AIIMS Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q549||Hypospadias, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Caudal epidural block |
Bupivacaine 0.25% (0.5 ml/kg) will be given before start of surgery and duration of analgesia in postoperative period is studied |
| Intervention |
Dorsal penile block |
0.25%. Bupivacaine 0.2 ml/kg will be given once before start of surgery and duration of analgesia is studied. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Age: 1-6years
2. ASA physical status I-II
3. Child undergoing hypospadias surgery |
|
| ExclusionCriteria |
| Details |
Patient parent’srefusal.
2. Patients with any contraindications to regional anaesthesia.
3. History of developmental delay or mental retardation, which will make observational
pain intensity assessment difficult.
4. History of allergic reaction to locaanaesthetic.
5. Rash or skin infection at the site of injection.
6. Anatomical abnormalities.
7. Bleedingdiathesis.
8. Coagulationdisorder.
9. History of renal, hepatic, cardiac disorder upper or lower infection or any
neurologicalabnormalities.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain |
0,1,2,4,6,8,12 and 24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total analgesic requirement, duration of first rescue analgesia, Hemodynamics, parents satisfaction |
0,1,2,4,6,8,12 and 24 hours postoperatively |
|
|
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)
|
23/03/2024 |
| 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="0"
Months="6"
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
|
This study compares the analgesic efficacy of Dorsal penile block vs Caudal epidural block with 0.25 %bupivacaine for postoperative analgesia in hypospadias surgery. Previously many blocks have been performed for postoperative analgesia like caudal epidural,sacral spinous block and dorsal penile block. Hence the efficacy of above 2 block is studied under guidance of ultrasound. |