| CTRI Number |
CTRI/2023/03/050508 [Registered on: 09/03/2023] Trial Registered Prospectively |
| Last Modified On: |
09/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of medicine below erector spinae muscle for pain relief in kids |
|
Scientific Title of Study
|
Analgesic efficacy of erector spinae plane block in pediatric patients - Our experience in a tertiary care hospital |
| Trial Acronym |
ESPB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gifty Susan Philip |
| Designation |
Senior resident |
| Affiliation |
St Johns Medical College and Hospital |
| Address |
Department of Anesthesia and Critical Care
St Johns Medical College and Hospital
Department of Anesthesia and Critical Care
St Johns Medical College and Hospital
Bangalore
KARNATAKA
560034
India |
| Phone |
9945122036 |
| Fax |
|
| Email |
giftyphilip@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gifty Susan Philip |
| Designation |
Senior resident |
| Affiliation |
St Johns Medical College and Hospital |
| Address |
Department of Anesthesia and Critical Care
St Johns Medical College and Hospital
Department of Anesthesia and Critical Care
St Johns Medical College and Hospital
Bangalore
KARNATAKA
560034
India |
| Phone |
9945122036 |
| Fax |
|
| Email |
giftyphilip@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Manjula Devi |
| Designation |
Professor |
| Affiliation |
St Johns Medical College and Hospital |
| Address |
Department of Anesthesia and Critical Care
St Johns Medical College and Hospital
Koramangala Bangalaore
Bangalore
KARNATAKA
560034
India |
| Phone |
9449059395 |
| Fax |
|
| Email |
drmanjula95@yahoo.com |
|
|
Source of Monetary or Material Support
|
| St Johns Medical College and Hospital,Koramangala, Bengaluru 560034 |
|
|
Primary Sponsor
|
| Name |
St Johns Medical College and Hospital |
| Address |
St Johns Medical College and Hospital Sarjapur Road, Bengaluru-560034 |
| Type of Sponsor |
Private 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 Gifty Susan Philip |
St Johns Medical College |
room no 10,2nd floor ,Operation Theatre complex, St Johns Medical College and Hospital
Bangalore
KARNATAKA |
919945122036
giftyphilip@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee St Johns Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2
Scheduled for elective abdominal, inguinal, hip and femur surgeries |
|
| ExclusionCriteria |
| Details |
History of allergy to local anesthetics
Coagulopathic disorders
Cardiac or Renal diseases
Infection at site of injection
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia |
postoperatively at 10min, 20min , 2 hour, 6hrs, 12hrs and 24 hrs. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) To assess frequency of rescue analgesics
b) To assess the total doses of rescue analgesics
|
a) Intraopertively baseline,at incision and every 15 min therafter
b) at the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/03/2023 |
| 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="1"
Months="0"
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)?
Response - NO
|
|
Brief Summary
|
This is a prospective ,observational,descriptive study which aims to determine the analgesic effects of erector spinae plane block (ESPB)in pediatric patients aged between 2-7yrs posted for abdominal and lower limb surgeries.
The primary objective of the study is to assess the duration of analgesia provided by ESPB (time to first request of rescue analgesic postoperatively) and secondary objectives are to assess frequency of rescue analgesics used and total number of rescue analgesics utilized during the intraoperative and postoperative period.
All children posted for abdominal ,inguinal,hip and femur surgeries fulfilling the inclusion criteria will receive ESPB after general anesthesia with dose of 0.5ml/kg with a maximum dose of 2mg /kg of 0.25% bupivacaine with dexamethasone 100mcg/kg at the level of lumbar vertebrae appropriate for the case.
Intraoperatively, heart rate (HR) ,mean arterial pressure (MAP) will be monitored every 15 minutes .If the vitals rises more than 20 percent of baseline values then iv rescue analgesics (fentanyl-0.5mcg/kg) will be given. Postoperatively the duration of analgesia provided by ESPB will be assessed by assessing revised FLACC score at 10 minutes, 20 minutes, 2 hours, 6 hours, 12 hours, 24 hours. If FLACC >3 then iv paracetamol will be given(15mg/kg) as rescue analgesic and if FLACC >5 then iv pethidine will be given (0.5mg/kg). Frequency of rescue analgesics and total doses of rescue analgesics given for a period of 24 hours during the postoperative period will be observed.
Descriptive and inferential statistics will be calculated to provide statistical significance. |