| CTRI Number |
CTRI/2022/07/043945 [Registered on: 12/07/2022] Trial Registered Prospectively |
| Last Modified On: |
06/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Study of Analgesic effect of bilateral ultrasound guided erector spinae plane block in pediatric lower abdominal surgeries. |
|
Scientific Title of Study
|
A randomised controlled interventional study for analgesic effect of bilateral ultrasound guided erector spinae plane block in pediatric lower abdominal surgeries,SMS hospital, Jaipur during 2021-2023 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neelam Dogra |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College and attached Hospitals, Jaipur |
| Address |
Department of Anesthesiology, SMS Medical College and attached Hospitals, Adarsh Nagar, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9928709289 |
| Fax |
|
| Email |
neelam_dogra24@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelam Dogra |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College and attached Hospitals, Jaipur |
| Address |
Department of Anesthesiology, SMS Medical College and attached Hospitals, Adarsh Nagar, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9928709289 |
| Fax |
|
| Email |
neelam_dogra24@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushma Jain S |
| Designation |
Junior Resident |
| Affiliation |
SMS Medical College and attached Hospitals |
| Address |
Department of Anesthesiology, SMS Medical College and attached Hospitals, Adarsh Nagar, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
7411262980 |
| Fax |
|
| Email |
sushma.jain2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, SMS Medical College and attached Hospitals, Jaipur |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology SMS Medical College and attached Hospitals Jaipur |
| Address |
JLN Marg, Adarsh Nagar, Jaipur |
| 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 |
| Dr Sushma Jain S |
Jk lon hospital operation theatre ,SMS Medical College and attached Hospitals |
JLN Marg, Adarsh Nagar, Jaipur
Jaipur
RAJASTHAN |
7411262980
sushma.jain2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS Medical College and attached Hospitals, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (2) ICD-10 Condition: K389||Disease of appendix, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector spinae plane block using Ropivacaine |
After general anesthesia , patient made to lie in lateral position and Erector spinae plane block given using 0.2% Ropivacaine (0.5ml/kg) under USG guidance. |
| Comparator Agent |
General anesthesia without erector spinae plane block.
|
General anesthesia in given and surgery started . Postoperative analgesia requirement is assessed. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients belonging to grade 1 & grade 2 ASA.
2.Patients undergoing lower abdominal surgeries. |
|
| ExclusionCriteria |
| Details |
1.Parental refusal.
2.Children with history of allergic reaction to drug.
3.Children undergoing bilateral surgeries.
4.Local infection at the site of puncture. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean FLACC pain score in first 24 hrs. |
FLACC score assessed at 0, 1, 2, 3, 6, 12, 24 hours after block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean dose of postoperative rescue analgesia in first 24 hours.
Time of first rescue analgesia. |
Assessed at 0,1,2,3,6,12,24 hours |
|
|
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)
|
15/07/2022 |
| 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="3"
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
|
Regional Anaesthesia is highly effective both for surgical procedure and postoperative pain management. USG Guided erector spinae plane block using 0.2% Ropivacaine (0.5 mg/kg ) is applied between the erector spinae muscle and the transverse process of the lumbar vertebrae for analgesia in lower abdominal surgeries in pediatric patients.The Study is used to assess analgesic effect of bilateral erector spinae plane block in lower abdominal surgeries for postoperative analgesia. |