| CTRI Number |
CTRI/2024/08/072843 [Registered on: 21/08/2024] Trial Registered Prospectively |
| Last Modified On: |
19/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of plain ropivacaine and ropivacaine with adjuvants in different participants undergoing chest surgeries and assessment of post operative pain as the main outcome |
|
Scientific Title of Study
|
A prospective observational study to assess post operative analgesia following addition of dexmeditomidine or dexamethasone to ropivacaine in erector spinae plane block in children undergoing thoracic surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tarannum Shaikh |
| Designation |
Junior resident doctor |
| Affiliation |
LOKMANYA TILAK MUNCIPAL MEDICAL COLLEGE AND HOSPITAL |
| Address |
FLAT 313 THIRD FLOOR GANDHI MARKET SION WEST MUMBAI
DEPARTMENT OF ANAESTHESIOLOGY, LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND HOSPITAL, MUMBAI
Mumbai
MAHARASHTRA
400022
India |
| Phone |
7219510997 |
| Fax |
|
| Email |
tanno999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anila D Malde |
| Designation |
Head of department of Anaesthesiology |
| Affiliation |
Lokmanya Tilak municipal medical college and general hospital |
| Address |
4th floor , department of anaesthesiology, Lokmanya Tilak municipal medical college and hospital , Sion West, Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9821085730 |
| Fax |
|
| Email |
dradmalde@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tarannum Shaikh |
| Designation |
Junior resident doctor |
| Affiliation |
Lokmanya Tilak municipal medical college and general hospital |
| Address |
FLAT 313 THIRD FLOOR GANDHI MARKET SION WEST MUMBAI, DEPARTMENT OF ANAESTHESIOLOGY, LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND HOSPITAL
Mumbai
MAHARASHTRA
400022
India |
| Phone |
7219520997 |
| Fax |
|
| Email |
tanno999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lokmanya Tilak Municipal medical college and hospital , Sion West Mumbai 400022 |
|
|
Primary Sponsor
|
| Name |
Lokmanya Tilak Municipal Medical college and Hospital |
| Address |
Lokmanya Tilak Municipal medical college and hospital, Sion west Mumbai 40022 |
| 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 Tarannum Shaikh |
Lokmanya Tilak municipal medical college |
N424, 4th floor , department of anaesthesiology Lokmanya Tilak municipal medical college and hospital , sion , Mumbai 400022
Mumbai
MAHARASHTRA |
7219520997
tanno999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee human research lokmanya tilak municipal medical college and muncicpal hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
All the children between the age group of 6 months to 18 years who have received general endotracheal anaesthesia plus Erector spinae plane block for open thoracic surgeries or VATS using plain ropivacaine or ropivacaine with adjuvants. |
|
| ExclusionCriteria |
| Details |
1.Patients who are in altered sensorium
2.Patients who are already sedated or on ventilatory support since visual analog score (VAS) or FLACC score cannot be checked in them |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study and compare the duration of post operative analgesia following addition of dexamethasone ( 0.15 mg/kg) or dexmedetomidine ( 1mcg/kg) to ropivacaine versus plain ropivacaine in ESPB following thoracic surgeries ( open /VATS) |
The post operative pain score would be assessed 3 hours 12 hours, 24 hours and 36 hours after the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare and assess the following in the group R (plain ropivacaine 0.4ml/kg of 0.5% ropivacaine), group RD (0.4ml/kg of 0.5% ropivacaine + 0.15 mg/kg dexamethasone) and group RDM (0.4ml/kg 0f 0.5% ropivacaine + 1 µg/kg dexmedetomidine)
1. The requirement of intra operative analgesic
2. The number of rescue analgesics required in first 24 hours
3. Parental satisfaction |
To assess the number of intra op rescue analgesics required and to assess post op PAIN score |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
30/08/2024 |
| 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
|
Thoracic surgeries like decortications can be done by either open approach or as video assisted thoracoscopic surgeries (VATS). Thoracotomy surgeries which involve stripping of pleura can give rise to significant pain. Adequate analgesia while recovering from thoracic surgeries is essential for providing patient comfort and preventing complications such as pneumonia and respiratory failure.
The erector spinae plane block (ESPB), first described by anaesthesiologist Mauricio Forero in 2016 is a multi-dermatomal sensory block that provides regional anaesthesia to the ipsilateral chest wall. The site of action is the dorsal and ventral rami of the thoracic nerves, typically extending from the level of T3 to T10. It has been tried for analgesia in thoracic, surgical and chest trauma patients, providing excellent pain relief while reducing narcotic requirements. The ESPB does not pose risk of direct neurological injury and can be placed when the patient is anaesthetized. In this study patients undergoing thoracic surgeries who receive general endotracheal anaesthesia and erector spinae plane block (ESPB) will be observed. Patient is taken inside the operation theatre , all the monitors are attached and general endotracheal anaesthesia is given using injection propofol 3mg/kg or inhalational sevoflurane. Non depolarising muscle relaxant is given . All patients receive injection fentanyl 2mcg/kg. Patient is given lateral decubitus position and ESPB is given between T5/T6 transverse process and erector spinae muscle using either plain ropivacaine ( group R- 0.4ml/kg of 0.5% ropivacaine or ropivacaine with adjuvants ( group RD 0.15mg/kg or group RDM 1mcg/kg dexmeditomidine ). Intra operatively the patient is monitored and if there is increase in pain stimuli in the form of increase in heart rate or systolic blood pressure by 20% then rescue analgesic injection fentanyl 0.5 mcg/kg is given and noted .After extubation the patient is observed in recovery room for 3 hours and if post operative pain score (VAS score or FLACC) is >3 injection fentanyl 0.5mcg/kg is given and noted. After 3 hours the patient is shifted to ward and if the pain still perssits injection paracetamol 15mg/kg is given and any other complications if present are noted.
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