| CTRI Number |
CTRI/2022/03/041052 [Registered on: 14/03/2022] Trial Registered Prospectively |
| Last Modified On: |
10/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
It is a study to see effectiveness of ultrasound guided sacral erector spinae block for postoperative analgesia in paediatric patients undergoing hypospadias repair. |
|
Scientific Title of Study
|
A study to compare ultrasound guided erector spinae block for post-operative analgesia in paediatric patients undergoing hypospadias repair. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
TEENA BANSAL |
| Designation |
Professor |
| Affiliation |
Pt. BDS PGIMS, Rohtak |
| Address |
Department of anesthesiology and critical care PGIMS ROHTAK
19/6 J, Medical Campus, PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
09034239374 |
| Fax |
|
| Email |
aggarwalteenu@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Niharika |
| Designation |
Junior Resident |
| Affiliation |
Pt. BDS PGIMS , Rohtak |
| Address |
Department of Anaesthesiology and critical care , 2nd floor modular ot complex ,PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8053933690 |
| Fax |
|
| Email |
nihurao5353@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Niharika |
| Designation |
Junior Resident |
| Affiliation |
Pt. BDS PGIMS , Rohtak |
| Address |
Department of Anaesthesiology and critical care , 2nd floor modular ot complex ,PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8053933690 |
| Fax |
|
| Email |
nihurao5353@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology Pt. BD Sharma PGIMS Rohtak |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Pt. BDS Pgims Rohtak |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Niharika |
Pt. BDS Pgims Rohtak |
Department of Anaesthesiology, 2nd floor new modular icu cum ot complex, PGIMS Rohtak
Rohtak
HARYANA |
8053933690
nihurao5353@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commttee Pt. BDS Pgims, Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, , (1) ICD-10 Condition: N99-N99||Intraoperative and postprocedural complications and disorders of genitourinary system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ultrasound guided erector spinae block |
Ultrasound guided erector spinae plane block for paediatric patients undergoing hypospadias repair. |
| Intervention |
Ultrasound guided erector spinae plane block |
Ultrasound guided erector spinae plane block in paediatric patients undergoing hypospadias repair. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Male |
| Details |
patients with ASA Physical status I or II scheduled to undergo surgery for hypospadias repair |
|
| ExclusionCriteria |
| Details |
Patients with hstory of developmental delay, allergic reactions to local anaesthetic, infection at the puncture site and parental refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| post operative analgesic consumption in 24 hrs. |
post operative analgesic consumption in 24 hrs. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Post operative pain score using FLACC scale
2. Time to first rescue analgesic
3. Total intraoperative fentanyl consumption.
4. Complications, if any |
1 FLACC score at every 15 minutes upto 1 hour every 30 min upto 2 hrs every 2 hrs upto 12 hrs and ecery 6 hrs upto 24 hrs.
2.Duration of analgesia
3. Number of times analgesia required.
4. Yes/No |
|
|
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)
|
20/03/2022 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pain is defined as unpleasant sensory and emotional experience associated with actual or potential tissue damage or descibed in terms of such damage. post operative pain can lead to delayed postoperative recovery of normal physiological functions. Caudal block is a most frequently used regional technique in children undergoing hypospadias repair for post operative pain management since it is simple, safe and has a higher success rate. Erector spinae plane block is a paraspinal plane block frst described to relieve thoracic pain. The sacral erector spinae plane block was first performed to provide analgesia to sacral dermatomes for pilonidal sinus surgery. Erector spinae plane block at sacral level can potentially block the pudendal nerve(S2-S4). Ultrasound assisted blocks help to visualise needle trajectory depth , injection site and spread of drug that reduces the number of attempts and improved patient comfort. Bupivacaine is long acting amide local anesthetic drug that is widely used for peripheral nerve block. So the present study is conducted to evaluate the effectiveness of sacral erector spinae plane block for post operative analgesia in paediatric patients undergoing hypospadias repair. |