| CTRI Number |
CTRI/2020/07/026364 [Registered on: 04/07/2020] Trial Registered Prospectively |
| Last Modified On: |
19/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Nerve block for inguinal hernia repair in children |
|
Scientific Title of Study
|
Ultrasound guided transversalis fascia plane block compared to caudal block for postoperative analgesia for herniotomy in pediatric population- A randomised comparative study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swati |
| Designation |
Associate Professor |
| Affiliation |
Department of Anesthesia, Indira Gandhi Institute of Medical Science ,Patna |
| Address |
9A, Road No 1, New Patliputra Colony
Room no. 21, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna- 800013
Patna
BIHAR
800013
India |
| Phone |
08544413241 |
| Fax |
|
| Email |
swatipgi2006@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
swati |
| Designation |
Associate Professor |
| Affiliation |
Department of Anesthesia, Indira Gandhi Institute of Medical Science ,Patna |
| Address |
9A, Road No 1, New Patliputra Colony
Room no. 21, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna- 800013
Patna
BIHAR
800013
India |
| Phone |
08544413241 |
| Fax |
|
| Email |
swatipgi2006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SWATI |
| Designation |
Associate Professor |
| Affiliation |
Department of Anesthesia, Indira Gandhi Institute of Medical Science ,Patna |
| Address |
9A, Road No 1, New Patliputra Colony
Room no. 21, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna- 800013
Patna
BIHAR
800013
India |
| Phone |
08544413241 |
| Fax |
|
| Email |
swatipgi2006@gmail.com |
|
|
Source of Monetary or Material Support
|
| India Gandhi Institute of Medical Sciences , Patna, Bihar, India |
|
|
Primary Sponsor
|
| Name |
Swati |
| Address |
Department of Anesthesia
Indira Gandhi institute of Medical , Sheikhpura, Patna |
| Type of Sponsor |
Other [None] |
|
|
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 |
| Swati |
Indira Gandhi Institute of Medical Sciences |
Room number 3, Department of Anesthesia
Patna
BIHAR |
08544413241
swatipgi2006@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indira Gandhi institute of Medical Science ethics com |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N51||Disorders of male genital organs in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Caudal block and transversalis fascia plane block is compared for analgesia in pediatric. |
After completion of surgery we are giving caudal or transversalis fascia plane block for analgesia. |
| Intervention |
Transversalis fascia plane block and caudal block |
0.25% Bupivacaine depending on the weight of the body |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Male |
| Details |
Undergoing herniotomy, American Society of Anaesthesiology I/II,posted under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Female child, infection or subcutaneous hematoma close to puncture site,altered hemostasis, history of previous surgical intervention, history of bleeding diathesis, patient on anticoagulant |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total rescue analgesia required for 24hours in postoperative period |
0,4,8,16,24hr postoperative period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| FLACC score at different timepoints in post operative period. |
0,4,8,16,24 hr postoperative period. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
18/07/2020 |
| Date of Study Completion (India) |
19/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
We will compare two different blocks, transversalis fascia plane block versus caudal block for postoperative analgesia in pediatric population.We will see the effectiveness of new block compared to caudal block |