| CTRI Number |
CTRI/2020/02/023189 [Registered on: 07/02/2020] Trial Registered Prospectively |
| Last Modified On: |
06/02/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pudendal block versus caudal block in children |
|
Scientific Title of Study
|
Comparison of the efficacy of USG guided pudendal block versus caudal block in
children undergoing urogenital surgeries- A prospective
randomized study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saraswathi Nagapaa |
| Designation |
Assistant professor |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Anaesthesia department,Super speciality block (PMSSY) , Bangalore medical college and research institute, Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
09663304834 |
| Fax |
|
| Email |
dr.saraswathi.pmssy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saraswathi Nagapaa |
| Designation |
Assistant professor |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Anaesthesia department,Super speciality block (PMSSY) , Bangalore medical college and research institute, Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
09663304834 |
| Fax |
|
| Email |
dr.saraswathi.pmssy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saraswathi Nagapaa |
| Designation |
Assistant professor |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Anaesthesia department,Super speciality block (PMSSY) , Bangalore medical college and research institute, Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
09663304834 |
| Fax |
|
| Email |
dr.saraswathi.pmssy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Paediatric surgery cases posted for urogenital surgeries |
|
|
Primary Sponsor
|
| Name |
Super speciality block PMSSY Anaesthesiology department |
| Address |
Super speciality block (PMSSY), Bangalore medical college and research institute, Bangalore-560002 |
| 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 Saraswathi N |
Super speciality block PMSSY, Bangalore medical college and research institute |
Anaesthesia department
Bangalore
KARNATAKA |
09663304834
dr.saraswathi.pmssy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore medical college and research institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q558||Other specified congenital malformations of male genital organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pudendal and caudal block |
Pudendal and caudal block for urogenital surgeries in children undergoing urogenital surgeries |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Male |
| Details |
Children undergoing urogenital surgeries -urethrolpsty |
|
| ExclusionCriteria |
| Details |
Parents refusal
Coagulation abnormalities |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Requirement of opoid and duration of analgesia |
Opoid consumption intraoperatively and duration of analgesia postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain score by modified objective pain score (MOPS) |
Postoperative pain score |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/02/2020 |
| 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="5" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Regional anaesthesia has been used to reduce the incidence and severity of postoperative pain,while reducing the duration of hospital stay. In children pudendal nerve block is considered as an effective alternative for caudal block in hypospadias surgery as it avoids central neuraxial complications and better postoperative pain management |