| CTRI Number |
CTRI/2024/12/078305 [Registered on: 18/12/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to compare costotransverse block with no block in pediatric patients undergoing video assisted thoracoscopic surgeries by assessing pain after surgery |
|
Scientific Title of Study
|
Analgesic Efficacy of Ultrasound Guided
Costotransverse Block in Paediatric patients undergoing Video Assisted Thoracoscopic
Surgery: A Randomised 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 Naveen V |
| Designation |
Junior Resident |
| Affiliation |
AIIMS PATNA |
| Address |
Department of anaesthesiology, OT Complex, 5th floor, IPD Building, AIIMS Patna, Phulwari Sharif, Patna, Bihar
Patna
BIHAR
801507
India |
| Phone |
9789759705 |
| Fax |
|
| Email |
naveenvenkatachalam91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandni Sinha |
| Designation |
Professor |
| Affiliation |
AIIMS PATNA |
| Address |
Department of anaesthesiology, OT Complex, 5th floor, IPD Building, AIIMS Patna, Phulwari Sharif, Patna, Bihar
Patna
BIHAR
801507
India |
| Phone |
7250333148 |
| Fax |
|
| Email |
chandni.doc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandni Sinha |
| Designation |
Professor |
| Affiliation |
AIIMS PATNA |
| Address |
Department of anaesthesiology, OT Complex, 5th floor, IPD Building, AIIMS Patna, Phulwari Sharif, Patna, Bihar
Patna
BIHAR
801507
India |
| Phone |
7250333148 |
| Fax |
|
| Email |
chandni.doc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, All India Institute of Medical Science, Patna, Phulwari Sharif, Patna, Bihar, India, 801507 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Science, Patna |
| Address |
Department of anaesthesiology, OT Complex, 5th floor, IPD Building, AIIMS Patna, Phulwari Sharif, Patna, Bihar, 801507, India |
| 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 Naveen V |
All India Institute of Medical Science, Patna |
OT-17, OT complex, 6th floor,IPD building, Aiims Patna, Phulwari Sharif, Patna, Bihar, 801507, India
Patna
BIHAR |
9789759705
naveenvenkatachalam91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J989||Respiratory disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Costotransverse block |
Costotransverse block given with 0.4ml per kg body weight of 0.2 % ropivacaine at T4-T5
and T6-T7 level single shot prior to surgery along with conventional analgesics postoperatively by Injection Paracetamol IV 6th hourly according to body weight and Injection fentanyl 0.5 mcg/kg IV will be given as rescue analgesia for patients if pain score FLACC or NRS score more than 4 |
| Comparator Agent |
without block |
Will be given only conventional analgesics postoperatively by injection Paracetamol IV 6th hourly according to body weight and injection fentanyl 0.5 mcg/kg IV will be given as rescue analgesia for patients if pain score FLACC/NRS score more than 4. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 1 to 14 years scheduled for Video Assisted Thoracoscopic Surgeries |
|
| ExclusionCriteria |
| Details |
Parent/patient refusal to participate in the study
Patients with coagulation disorders.
Patients hypersensitive to study medications.
Patients with developmental or mental delay.
Skin lesions or infection at the planned site of needle insertion
Congenital vertebral anomalies
Patients planned for postoperative ventilation |
|
|
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 evaluate the 24-h postoperative opioid consumption per kg body weight |
From the end of surgery to 24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate postoperative pain scores using the FLACC/NRS scale |
30 minutes,
2,4,8,16 and 24 hours |
| To evaluate intraoperative fentanyl consumption |
from the time of administration of block to the end of the surgery |
To evaluate side effects like vomiting, respiratory depression and sedation using
POSS scale |
from the end of surgery to 24 hours post operatively |
| Time to 1st rescue analgesia administration. |
from the time of administration of block to the first need of use of analgesic administration |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/01/2025 |
| 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="2"
Months="0"
Days="0" |
|
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
|
Video-assisted thoracoscopic surgery is a commonly done procedure in Paediatric patients. These patients experience moderate to severe pain postoperatively increasing the risk of postoperative complications and delaying their recovery. Conventional analgesics like opioids have systemic adverse effects, insufficient pain alleviation and delayed recovery. This has led to the advent of locoregional analgesic techniques like ultrasound (USG) paravertebral block (PVB), which blocks both the dorsal and ventral rami providing adequate pain relief. However this block is accompanied by complications like hematoma, hypotension and pneumothorax. Lately US guided costotransverse block (CTB) has been described as a peri PVB where the drug is deposited above superior costotransverse ligament. Its use has been described in adult breast and Paediatric cardiac surgeries. The purpose of this study is to investigate the costotransverse block’s analgesic effectiveness in Paediatric VATS patients. This study aims to provide insight into the possible advantages of incorporating this method into Paediatric thoracic surgery procedures. |