| CTRI Number |
CTRI/2017/11/010548 [Registered on: 17/11/2017] Trial Registered Prospectively |
| Last Modified On: |
17/11/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Pilot Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of two methods of penile and ring blocks for pediatric circumcision
|
|
Scientific Title of Study
|
Comparison between Dorsal Penile nerve block plus Ring block vs. Ring block alone in pediatric circumcision – a prospective pilot study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vrushali C Ponde |
| Designation |
Pediatric Anaesthesiologist |
| Affiliation |
Surya Childrens Hospital, Santacruz, Mumbai |
| Address |
Surya Children Hospital.
OT, first floor
S V road
Santacruz(w) 400054
Surya Children Hospital.
OT, first floor
S V road
Santacruz 400054
Mumbai (Suburban)
MAHARASHTRA
400054
India |
| Phone |
9819886502 |
| Fax |
|
| Email |
vrushaliponde@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Vrushali C Ponde |
| Designation |
Pediatric Anaesthesiologist |
| Affiliation |
Surya Childrens Hospital, Santacruz, Mumbai |
| Address |
Surya Children Hospital.
OT, first floor
S V road
Santacruz(w) 400054
Surya Children Hospital.
OT, first floor
S V road
Santacruz 400054
Mumbai (Suburban)
MAHARASHTRA
400054
India |
| Phone |
9819886502 |
| Fax |
|
| Email |
vrushaliponde@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Vrushali C Ponde |
| Designation |
Pediatric Anaesthesiologist |
| Affiliation |
Surya Childrens Hospital, Santacruz, Mumbai |
| Address |
Surya Children Hospital.
OT, first floor
S V road
Santacruz(w) 400054
Surya Children Hospital.
OT, first floor
S V road
Santacruz 400054
Mumbai (Suburban)
MAHARASHTRA
400054
India |
| Phone |
9819886502 |
| Fax |
|
| Email |
vrushaliponde@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Childrens Anaesthesia Services, Mumbai |
|
|
Primary Sponsor
|
| Name |
Surya Children Hospital |
| Address |
S V Road, Santacruz west, Mumbai-400054 |
| 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 Vrushali C Ponde |
Surya Childrens Hospital |
Surya Children Hospital.
OT, first floor
S V road
Santacruz 400054
Mumbai (Suburban)
MAHARASHTRA |
9819886502
vrushaliponde@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Scientific Research Committee, Surya Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Forty pediatric patients less than 10 years of age and ASA physical status 1 posted for circumcision, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
10.00 Year(s) |
| Gender |
Male |
| Details |
Forty paediatric patients less than 10 years of age and ASA physical status 1 posted for circumcision |
|
| ExclusionCriteria |
| Details |
patients without consent, known allergy to local anaesthetic, known coagulopathy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Analgesia |
Surgical stimulation. Heart rate changes due to surgical incision will assess the analgesia rendered by the block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| complications |
Complications noted during and after the regional block within 24 hours |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/12/2017 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Inclusion, exclusion criteria and enrollment will be done as mentioned. One half of patients will recieve dorsal penile block and ring infiltration while the rest will be given ring infiltration alone. Comparison will be made among the two groups on the basis of age, weight and incidence of block failure (i.e. rise in heart rate of more than 20%from baseline on surgical stimulus), primary outcome being analgesia and secondary outcome being complications. Appropriate test will be used for statistical analysis. |