| CTRI Number |
CTRI/2023/10/058504 [Registered on: 11/10/2023] Trial Registered Prospectively |
| Last Modified On: |
08/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the effect of ultrasound guided erector spinae plane block on opioid requirement during operation in children undergoing video assisted thoracoscopic surgery under general anaesthesia |
|
Scientific Title of Study
|
Effect of ultrasound guided erector spinae plane block on intra operative opioid requirement in children undergoing video assisted thoracoscopic surgery under general anaesthesia |
| 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 Anshul |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Room No 302 3rd Floor BL Taneja Block Department of Anaesthesiology Maulana Azad Medical College New Delhi
New Delhi
DELHI
110002
India |
| Phone |
08571852630 |
| Fax |
|
| Email |
redhuanshul18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonia Wadhawan |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Room No 302 3rd Floor BL Taneja Block Department of Anaesthesiology Maulana Azad Medical College New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9810946845 |
| Fax |
|
| Email |
Soniawadhawan@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anshul |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Room No 302 3rd Floor BL Taneja Block Department of Anaesthesiology Maulana Azad Medical College New Delhi
New Delhi
DELHI
110002
India |
| Phone |
08571852630 |
| Fax |
|
| Email |
redhuanshul18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated Lok Nayak Hospital |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Maulana Azad Medical College and associated Lok Nayak Hospital,JLN Marg New Delhi,110002 |
| 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 Anshul |
Maulana Azad Medical College and associated Lok Nayak Hospital |
Department of Anaesthesiology, BL Taneja Block ,Maulana Azad Medical College and associated Lok Nayak Hospital, JLN Marg
New Delhi
DELHI |
8571852630
redhuanshul18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee,Maulana Azad Medical College |
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 |
Control group |
In this group, anaesthesia will be maintained as per standard techniques. At the end of the procedure, the port site and intercostal drainage tube [ICD] insertion site will be infiltrated with 2-3 ml of 0.25% bupivacaine. Patient will be observed for 1st 24-hour post operatively. |
| Intervention |
Erector spinae plane block |
Ultrasound guided erector spinae plane block will be performed after induction with the patient in the lateral position by an experienced anaesthesiologist. Under all aseptic precautions, a high frequency linear ultrasound transducer will be placed in the paraspinal region, longitudinally oriented and lateral to the thoracic [T4-T6] spinous process. A 20G,50mm nerve block needle will be inserted in the craniocaudal direction deeper to the erector spinae muscle. After confirming the needle position by hydro dissection with 0.5 ml saline, injection of 0.25% bupivacaine 0.5 ml/kg will be administered in the fascial plane under the erector spinae muscle. After completion of block surgery will commence and observed till 1st 24hr post operatively |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children 3-10 years of age belonging to American Society of Anaesthesiologists grade 1,2,3 undergoing elective video assisted thoracoscopic surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1.History of bleeding diathesis
2.Child receiving anticoagulant treatment
3.Infection at the region of block
4.Any known allergies to local anaesthetics or opioids |
|
|
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 |
| The mean intraoperative opioid requirements in both the groups[Erector spinae plane block group or Control group] |
Till total duration of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Post operative pain score using VAS or FLACC scale
2.Total number of doses of analgesia required in the 1st 24 hour postoperatively
3.Adverse events if any like haematoma due to block, nausea, vomiting, respiratory depression
4.To document the time to perform the Erector spinae plane block which is defined as the time from the start of nerve block needle insertion till removal of the needle after administering the local anaesthetic drug in the erector spinae plane. |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
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)
|
20/10/2023 |
| 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 Yet Recruiting |
| 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
|
We are evaluating the effect of ultrasound guided erector spinae plane block on intra operative opioid requirement in children undergoing Video Assisted Thoracoscopic surgery [VATS] under general anaesthesia in Lok Nayak Hospital and associated Maulana Azad Medical College, New Delhi. A total of 14 patients with 7 patients in each group will be enrolled for the study. Patients guardian/parent will be explained about the study and written informed consent will be obtained from the parent/guardian. We will be using standard general anaesthesia for induction of the patients following which ultrasound guided block site will be identified and local anaesthetic drug will be administered in the erector spinae plane block group. The mean intraoperative opioid requirement in both the groups[Erector spinae plane block group/Control group] will be calculated. Patients will be followed up postoperatively for 24 hours, during which the VAS/FLACC scale score for pain and the number of doses of analgesia required in the first 24 hours will be determined. |