| CTRI Number |
CTRI/2022/07/044518 [Registered on: 29/07/2022] Trial Registered Prospectively |
| Last Modified On: |
27/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Compare the analgesic effect of Ultrasound guided rhomboid intercostal block and Erector spinae plane block in pediatric patients for video-assisted thoracoscopy surgery . |
|
Scientific Title of Study
|
Analgesic efficacy of Ultrasound guided rhomboid intercostal block versus Erector spinae plane block in pediatric patients undergoing video-assisted thoracoscopy surgery: A Randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Poonam Kumari |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical sciences-Patna |
| Address |
Department of Anaesthesia,Room No-506,5th floor Ot complex,B Block ,Aiims Patna
Patna
BIHAR
801507
India |
| Phone |
9473199126 |
| Fax |
|
| Email |
drpoonam1981@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Poonam Kumari |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical sciences-Patna |
| Address |
Department of Anaesthesia,Room No-506,5th floor Ot complex,B Block ,Aiims Patna
Patna
BIHAR
801507
India |
| Phone |
9473199126 |
| Fax |
|
| Email |
drpoonam1981@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Poonam Kumari |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical sciences-Patna |
| Address |
Department of Anaesthesia,Room No-506,5th floor Ot complex,B Block ,Aiims Patna
Patna
BIHAR
801507
India |
| Phone |
9473199126 |
| Fax |
|
| Email |
drpoonam1981@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology,B Block 5th Floor OT, Aiims Patna |
|
|
Primary Sponsor
|
| Name |
Department of AnaesthesiaAiims Patna |
| Address |
Department of Anaesthesia,Room No-506,5th floor Ot complex,B Block ,Aiims Patna |
| 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 |
| Poonam Kumari |
Aiims Patna |
Pediatric OT,6th floor of OT Complex,
Patna
BIHAR |
9473199126
drpoonam1981@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethical Committee AIIMS Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J984||Other disorders of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Erector Spinae Block |
Will receive ESP Block after general anaesthesia.Erector spinae block will be performed at the T5 level of the spine using an in-plane approach.10 mL of 0.2% ropivacaine .To compare the requirement of perioperative analgesics (total dose of Fentanyl) in 24 hours |
| Intervention |
rhomboid intercostal block |
will receive RIB Block after general anaesthesia.10 ml 0.2% ropivacaine will be administered at the T6-7 level.To compare the requirement of perioperative analgesics (total dose of Fentanyl) in 24 hours |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA I/II
2.Age (Either Sex) – 7 to 12 years
3.Scheduled for VATS
|
|
| ExclusionCriteria |
| Details |
1.ASA physical status > Grade III
2.Allergic to local anesthetics
3.Local infection at or near the needle insertion site
4.Severe respiratory compromise
5.Coagulopathy or medical anticoagulation
6.Mental disorder
7.Communication failure
8.Inability to understand the functionality of patient-controlled analgesia pump
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the requirement of perioperative analgesics (total dose of Fentanyl) in 24 hours . |
24 hours . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time for 1st rescue analgesia (IV PCA fentanyl):
Total dose of fentanyl used in 24 hours:
Worst NRS score in 24 hours:
Mean NRS score of 24 hours:
|
30 min,2hr,4hr,8hr,12hr,24hr |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Video-assisted thoracoscopic surgery (VATS) has become an increasingly important and common paediatric surgical procedure.This study is novel as no studies have been done earlier to compare Erector spine block vs RIB for VATS surgeries. So our study is focused on finding out which approach among them is more effective in terms of requirement of analgesics, pain scores and adverse effects. |