| CTRI Number |
CTRI/2021/04/032717 [Registered on: 09/04/2021] Trial Registered Prospectively |
| Last Modified On: |
09/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Erector Spinae Plane Block versus Caudal Epidural Block for children undergoing lower abdominal surgery |
|
Scientific Title of Study
|
Comparison of Erector Spinae Plane block versus Caudal Epidural block in pediatric patients undergoing lower abdominal surgery under general anesthesia- a randomised study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashutosh Pandey |
| Designation |
PG student |
| Affiliation |
AIIMS Bhopal |
| Address |
Department of Anesthesiology and Critical Care
Room 1 PG boys hostel AIIMS Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8960589413 |
| Fax |
|
| Email |
ashu95pandey@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Zainab Ahmad |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Bhopal |
| Address |
Department of Anesthesiology and Critical Care, AIIMS Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8860048951 |
| Fax |
|
| Email |
drzainabhaq@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Zainab Ahmad |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Bhopal |
| Address |
Department of Anesthesiology and Critical Care, AIIMS Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8860048951 |
| Fax |
|
| Email |
drzainabhaq@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS BHOPAL (Non funded) |
|
|
Primary Sponsor
|
| Name |
Dr Zainab Ahmad |
| Address |
Associate Professor,Department of Anesthesiology and Critical Care, AIIMS Bhopal |
| Type of Sponsor |
Other [Guide for study planned to fulfil requirement of PG thesis (MD Anesthesiology)] |
|
|
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 Ashutosh Pandey |
Department of Anesthesiology and Critical Care, and Department of Pediatric Surgery AIIMS Bhopal |
AIIMS Bhopal,Saket Nagar,Bhopal
Bhopal
MADHYA PRADESH |
8960589413
ashu95pandey@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee-Post Graduate Research(IHEC-PGR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Caudal Epidural Block (Ultrasound guided) |
Bupivacaine 0.25% 1 ml/kg |
| Intervention |
Erector Spinae Plane Block (Ultrasound guided) |
Bupivacaine 0.25% 0.5-0.8 ml/kg |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
The study will include all paediatric patients of age 1 year - 9 years, of either sex, ASA(American Society of Anesthesiologists classification of Physical Status) grade I and II undergoing elective or emergency lower abdominal surgery. |
|
| ExclusionCriteria |
| Details |
·Contraindications to regional technique e.g.
allergy to local anesthetic drugs, infection
around site of block.
.Any coagulation disorder, sepsis.
·Patient having anatomical deformities &
progressive neurological disorder,
·Patient with cutaneous anomalies (angioma, hair
tuft, naevus, dimple at the site of block)
·Inability to identify landmarks.
·Patient on enti-epileptic drugs or any other
enzyme inducers.
·Hypersensitivity/contra-indication to any of the
study drugs.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of post-operative analgesia, defined as time to first request of rescue analgesia ( defined as a FLACC score 4 or verbal request of analgesics from verbal children) at any time from the time of completion of surgery. |
Patients will be evaluated at 0, 30 minutes, 1 hours, 2 hours, 6 hours, 12 hours and 24 hours after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Intraoperative opioid requirement - number of additional doses of Fentanyl administered intraoperatively.
2. Postoperative pain scale - FLACC score
3. Number of doses and cumulative dose of rescue analgesic in the postoperative 24 hours.
4. Number of patients requiring any rescue analgesic during the first 24 hours after surgery.
5. Side effects if any
6. Parental satisfaction on a numerical scale of 1-10.
|
Patients will be evaluated at 0, 30 minutes, 1 hours, 2 hours, 6 hours, 12 hours and 24 hours after surgery. |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2021 |
| Date of Study Completion (India) |
29/07/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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)?
Response - NO
|
Brief Summary
Modification(s)
|
Aim of the study is to compare the effect of Erector Spinae Plane Block with the effect of Caudal Epidural Block in pediatric patients undergoing lower abdominal surgery under general anesthesia. Study will be a single blind randomised study with blinding of outcome assessors and will be conducted in AIIMS Bhopal under the Department of Anesthesiology, and Department of Pediatric Surgery. Both erector spinae plane block and caudal epidural block will be proceeded under the Ultrasound guidance. Primary outcome to be compared will be the duration of post operative analgesia defined as time to first request of rescue analgesia. Randomisation will be done using computer generated random number table and allocation concealment will be done using sequentially numbered opaque sealed envelopes. The study will include all pediatric patient of age 1- 9 years of either sex, ASA(American society of Anesthesiology classification of physical status) grade 1 and 2 undergoing elective and emergency lower abdominal surgeries. Patients having any contraindications to regional technique, any coagulation disorder, local infection around site of block, any anatomical deformity, progressive neurological disorder, any cutaneous anomaly, any hypersensitivity to the local anesthetics or inabilty to identify the landmarks; will be excluded from the study. A standard anesthesia technique will be followed in all the patients included in the study. Well informed written consent will be taken from the patients included in the study. All the records will be confidential, and the patient identity would be known to the chief investigatorand would not be released to anybody else. Participation in the study will be voluntary and refusal to participate will not influence care of the participants in the hospital anyway.
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