| CTRI Number |
CTRI/2024/10/074687 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
26/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparing between the efficacy of erector spinae plane block and thoracic epidural in paediatric patients undergoing thoracic surgery under general anaesthesia |
|
Scientific Title of Study
|
Comparison between the efficacy of ultrasound guided erector spinae plane block and thoracic epidural analgesia in paediatric patients undergoing unilateral thoracic surgery under general anaesthesia
A randomized controlled trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neeraj Kumar Sharma |
| Designation |
PG Resident |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Anaesthesia
5th floor New Academic block
Lady Hardinge Medical College
Shaheed Bhagat Singh Marg DIZ Area Connaught Place New Delhi 110001
Central
DELHI
110001
India |
| Phone |
9711255432 |
| Fax |
|
| Email |
shneeraj97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vidhi Chandra |
| Designation |
Professor |
| Affiliation |
Lady Hardnige Medical College |
| Address |
Department of Anaesthesia
5th floor New Academic block
Lady Hardinge Medical College
Shaheed Bhagat Singh Marg DIZ Area Connaught Place New Delhi 110001
Central
DELHI
110001
India |
| Phone |
9953204447 |
| Fax |
|
| Email |
drvidhivd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vidhi Chandra |
| Designation |
Professor |
| Affiliation |
Lady Hardnige Medical College |
| Address |
Department of Anaesthesia
5th floor New Academic block
Lady Hardinge Medical College
Shaheed Bhagat Singh Marg DIZ Area Connaught Place New Delhi 110001
DELHI
110001
India |
| Phone |
9953204447 |
| Fax |
|
| Email |
drvidhivd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia
Lady Hardinge Medical College
Shaheed Bhagat Singh Marg DIZ Area Connaught Place New Delhi India 110001
|
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia Lady Hardinge Medical College |
| Address |
Department of Anaesthesia
5th floor New Academic block
Lady Hardinge Medical College
Shaheed Bhagat Singh Marg DIZ Area Connaught Place New Delhi 110001 |
| 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 Neeraj Kumar Sharma |
Lady Hardinge Medical College |
Department of Anaesthesia
room no 518
5th floor New Academic block
Lady Hardinge Medical College
Shaheed Bhagat Singh Marg DIZ Area Connaught Place New Delhi 110001
Central
DELHI |
9711255432
shneeraj97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional Ethics comittee for human research LHMC and associated hospitals, New Delhi |
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 |
efficacy of thoracic epidural analgesia in paediatric patients undergoing unilateral thoracic surgery under general anaesthesia |
patient under general anaesthesia in lateral position blind epidural technique is used. 22G epidural catheter inserted through 19G Touhy’s needle via epidural catheter bolus 0.25% bupivacaine (0.5ml/kg) given and 50% of same repeated throughout surgery at regular interval
|
| Intervention |
ultrasound guided erector spinae plane block in paediatric patients undergoing unilateral thoracic surgery under general anaesthesia |
patient under general anaesthesia in prone position. erector spinae muscle identified on either side using ultrasound catheter in inserted, bolus of 0.25% bupivacaine(0.5ml/kg) given and 50 % same repeated throughout surgery at regular intervals |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Paediatrics patients of either sex belonging to age group 2 -7yrs with ASA physical status I & II scheduled for unilateral thoracic surgery under general anaesthesia.
|
|
| ExclusionCriteria |
| Details |
History of any relevant drug allergy or chronic pain.
Any contraindication to the regional block such as coagulation disorder infection at needle insertion site.
Deformity of thoracolumbar spine.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean opioid consumption 24hr postoperatively of ultrasound guided erector spinae plane block and thoracic epidural analgesia in paediatric patients undergoing thoracic surgery under general anaesthesia
|
At 0 hour 1 hour 3 hour 6 hour 12 hour and 24 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Median [Interquartile range] FLACC score
2.Mean / Median time of first rescue analgesia
3.Proportion of patients developing complications (nausea hypotension bradycardia respiratory depression urinary retention)
4.Median (IQR) parental satisfaction score (Likert scale)
|
1. At 0 hour 1 hour 3 hours 6 hours 12 hours 24 hours in the postoperative period
2. in 24 hours postoperatively
3. from 0 hours to 24 hours postoperatively
4. At 24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/10/2024 |
| 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="10"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Thoracic epidural analgesia (TEA) with continuous catheter infusion is
widely regarded as a superior technique in providing prolonged duration of
postoperative analgesia in adult as well as paediatric patients in thoracic
surgery but
with newer peripheral blocks such as erector spinae plane block (ESPB) with a
continuous catheter infusion, one can achieve the same amount of pain control at much
lesser complications when compared to
thoracic epidural.
A
lot of studies have been published where epidural analgesia is compared to
erector
spinae
plane block in adult in terms of their efficacy and safety.However,
to the best of our knowledge, there is limited literature on comparison between
the efficacy of ultrasound guided erector spinae plane block (ESPB) and
thoracic epidural analgesia (TEA) with continuous catheter infusion in
paediatric patients undergoing unilateral thoracic surgery. This study has been planned to compare the efficacy of two techniques in post
operative pain control in paediatric patients under going unilateral thoracic
surgery.
|