| CTRI Number |
CTRI/2024/06/068621 [Registered on: 10/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| 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
|
Study to Compare the effect of combined Rhomboid intercostal block and sub serratus plane block with surgical site local anaesthetic drug infiltration for pain relief in children undergoing VAT surgery |
|
Scientific Title of Study
|
Combined Rhomboid intercostal block and Sub serratus plane block for perioperative analgesia 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 Shubheshwari Anupam |
| Designation |
Post graduate student |
| Affiliation |
Maulana Azad Medical College, New Delhi, 110002 |
| Address |
Room no.302, B L Taneja Block, Department of Anaesthesiology and intensive care, Maulana Azad Medical College , New Delhi, 110002
New Delhi
DELHI
110002
India |
| Phone |
7004861545 |
| Fax |
|
| Email |
shubheshwari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonia Wadhawan |
| Designation |
Director Professor |
| Affiliation |
Maulana azad medical college, New Delhi, 110002 |
| Address |
Room no.302, B L Taneja Block, Department of Anaesthesiology and intensive care, Maulana Azad Medical College , New Delhi, 110002
New Delhi
DELHI
110002
India |
| Phone |
9810946845 |
| Fax |
|
| Email |
soniawadhawan@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubheshwari Anupam |
| Designation |
Post graduate student |
| Affiliation |
Maulana azad medical college , New Delhi, 110002 |
| Address |
Room no.302, B L Taneja Block, Department of Anaesthesiology and intensive care, Maulana Azad Medical College , New Delhi, 110002
New Delhi
DELHI
110002
India |
| Phone |
7004861545 |
| Fax |
|
| Email |
shubheshwari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lok Nayak Hospital, Jawaharlal Nehru Marg, near Delhi gate, New Delhi -110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College, 2, Bahadur Shah Zafar 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 Shubheshwari Anupam |
Lok Nayak Hospital |
OT 3, 3rd Floor, New Operation Theatre block, Department of Anaesthesiology and intensive care
New Delhi
DELHI |
7004861545
shubheshwari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee, Maulana Azad Medical College, 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 |
| Intervention |
Combined Rhomboid intercostal block and sub serratus plane block |
After induction of anaesthesia, single shot Combined RISS block will be given with 7 and 10 ml of 0.2 % ropivacaine respectively pre operatively in children undergoing video assisted thoracoscopic surgery under general anaesthesia. After that requirement of rescue analgesic drug will be recorded till 24 hours post surgery. |
| Comparator Agent |
Site infiltration with 0.2% ropivacaine |
In this group,two shots of 0.2 % ropivacaine will be given. First, before surgical incision at the site of ICD tube and port site and second, at the post operative ICD tube site. After that requirement of rescue analgesic drug will be recorded till 24 hours post surgery. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Children of age 3-8 years belonging tp American Society of Anesthesiologists(ASA) grades I, II, III undergoing Video assisted thoracoscopic surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1. History of bleeding diathesis
2. Children receiving anticoagulant treatment
3. Infection at the region of block
4. Any known allergy to local anaesthetic or opoids |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total intraoperative fentanyl requirement in children undergoing video assisted thoracoscopic surgery (VATS) under general anaesthesia |
Within 2 hours after surgical incision |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Total intraoperative requirement of sevoflurane
2. Post operative pain score using Visual Analogue scale( VAS) and the ( FLACC ) behavioral scale at 0,3,6,12,24 hours.
3. Total number of doses of rescue analgesic required I the first 24 hours postoperatively
4. Frequency of occurrence of adverse events like post operative nausea and vomiting, urinary retention, sedation, pruritus |
24 hours in post operative period |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
20/06/2024 |
| 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="1"
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
|
We are evaluating the effect of ultrasound guided Combined Rhomboid intercostal block and sub serratus plane block (RISS) for perioperative analgesia in children in the age group 3-8 years, undergoing video assisted thoracoscopic surgery under general anaesthesia. The objective of the study is to compare the efficacy of RISS block with Surgical site local infiltration for perioperative analgesia taking a total sample size of 32 patients, 16 patients in each group. |