| CTRI Number |
CTRI/2018/01/011559 [Registered on: 25/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
14/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
study the various regional anesthetic technique to reduce the pain of thoracotomy after cardiac surgery in children. |
|
Scientific Title of Study
|
“Comparison between Ultrasound guided Serratus anterior Plane Block, Intercostal Nerves Block and Pectoral Nerves (PECS) 1 Block for Post-operative Thoracotomy Pain in pediatric cardiac surgical patients†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Brajesh Kaushal |
| Designation |
Senior Resident (Acad) |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Cardiac Anesthesia , C N Center, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9425772151 |
| Fax |
09425772151 |
| Email |
brajeshkaushal3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Chauhan |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Cardiac Anesthesia , C N Center, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
sdeep61@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Chauhan |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Cardiac Anesthesia , C N Center, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
sdeep61@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Cardiac Anesthesia C. N. Center, All India Institute of medical science, Ansari Nagar new delhi 110029 |
|
|
Primary Sponsor
|
| Name |
Department of Cardiac Anesthesia |
| Address |
AIIMS, Ansari Nagar, New Delhi |
| 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 Sandeep Chauhan |
All India Institute of Medical Sciences |
Department of Cardiac Anesthesia,7 th floor and Cardiac OT and ICU First Floor, C. N. Center, AIIMS, New Delhi
New Delhi
DELHI |
9868398101
sdeep61@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for post graduate research, All India Institute of Medical sciences, Ansari Nagar, New Delhi 110029 |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
having congenital cardiac diseases with ASA grade I or II for correction of defect via thoracotomy incision., (1) ICD-10 Condition: Q250||Patent ductus arteriosus, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intercostal Nerve Block (ICNB) |
Intercostal nerve block: intercostal nerve block will be performed after skin closure and in lateral position with thoracotomy side up palpating the rib in the mid axillary line. A 25 gauge needle is introduce perpendicularly through the skin onto the rib and gently walked down the rib to its caudad edge. At this point, the needle is angled posteriorly and advanced slightly medially and posteriorly so that it is almost parallel to the rib, until the tip of the needle lies 1-2 mm beneath the edge of the rib. The bevel of the needle faces cephalad. A loss of resistance is frequently experienced and the needle felt to slide into the subcostal space. After aspirating if no blood or air is withdrawn 1 ml of 0,5% Ropivacaine (diluted upto 0,2% with normal saline in case of small children) is injected in each space (2 space above and 3 space below the thoracotomy incisiona).11
|
| Intervention |
Ultrasound guided Pectoral Nerves (PECS) 1 Block |
The Pectoral nerves (PECS) 1 block requires Ultrasound guided injection of 2.5 mg/kg ropivacaine 0.5% diluted with normal saline according to age into the space between Pectoral Major Muscle (PMM) and the Pectoral Minor Muscle (PmM). With the probe at the mid clavicular level and angled inferolaterally, first locate the axillary artery and vein. Next move the probe laterally until pectoralis minor and serratus anterior are identified. Locate the 2nd rib immediately under the axillary artery, then count the 3rd rib and with further lateral probe movement, the 4th rib. With the image centered at the level of 3rd rib, advance the needle in plane from medial to lateral in an oblique manner until the tip lies between pectoralis major and minor and Inject the calculated amount of ropivacaine 0.5% according to weight of children. |
| Intervention |
Ultrasound guided Serratus anterior plane block (SAPB) |
Ultrasound guided SAP Block will be performed while patient is still in lateral position with the thoracotomy side up. A linear Ultrasound Transducer (10-12 MHz) will be placed in a sagittal plane over the mid clavicular region of the thoracic cage, then the ribs were counted down until the fifth rib identify in the mid axillary line. The following muscles will be identified overlying the fifth rib : The Latissimus dorsi (superficial and posterior), Teres major (superior), and Serratus muscles (deep and inferior). A 19 gauge, 50 mm, touhy needle will introduced in place with respect to the ultrasound probe, targeting the plane superficial to the serratus anterior muscle. Under continuous ultrasound guidance 2.5 mg/kg Ropivacaine 0.5% diluted with normal saline according to age will be injected in this plane.10 |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Pediatric patients between age 1 to 14 years, ASA Grade I or II with congenital heart disease i.e. Patent ductus arteriosus (PDA), Coarctation of Aorta (CoA), Atrial Septal defect (ASD), Partial anomalous pulmonary venous return (PAPVR) and Blalog taussig shunt (B T shunt) requiring elective thoracotomy for surgical correction or repair. |
|
| ExclusionCriteria |
| Details |
Children requiring sternotomy for correction of heart defect, children with emergency cardiac surgery, children having deranged coagulation profile and children with previous thoracotomy will be excluded from the study. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of post operative analgesia and duration of post operative analgesia by Modified Objective Pain Score (MOPS) between serratus anterior plane block (SAPB), Intercostal nerve block (ICNB), and pectoral nerves (PECS) 1 block in pediatric patients undergoing a thoracotomy. |
After completion of surgery and administering the block, hemodynamic parameters noted and patient will be shifted to ICU with endotracheal tube in situ. Extubation time, monitoring of pulse rate, blood pressure SpO2, ECG, Respiratory rate and Modified objective pain score (MOPS) will be recorded in ICU every 2 hours interval for upto 12 hours after extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the side effect or complications, rescue analgesia (fentanl) consumption, associated with the three procedures. |
After completion of surgery and administering the block, hemodynamic parameters noted and patient will be shifted to ICU with endotracheal tube in situ. Extubation time, monitoring of pulse rate, blood pressure SpO2, ECG, Respiratory rate and Modified objective pain score (MOPS) will be recorded in ICU every 2 hours interval for upto 12 hours after extubation. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "108"
Final Enrollment numbers achieved (India)="108" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2017 |
| Date of Study Completion (India) |
30/06/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="20" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published in Journal of Cardiothoracic and Vascular Anesthesia |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
All preoperative cardiac
medication will be continue until the morning of surgery. Premedication will
consist of 0.1 mg/kg morphine and 0.5 mg/kg promethazine intramuscularly 1 hour
before the surgery. After coming to operative room, initial monitoring will
include a 5-lead electrocardiogram, Noninvasive blood pressure, and pulse
oxymetry. Anesthetic induction will performed with Sevoflurane with oxygen and
air, 50% each. Anesthesia will supplemented with intravenous midazolam, 0.05 to
0.1 mg/kg; fentanyl 2 mcg/kg and rocuroneum 0.8 mg/kg. The maintenance will be
achieved with midazolam, fentanyl, sevoflurane and atracurium as required.
Following measurements will be obtained for each
patient. The hemodynamic parameters – Heart rate and Blood pressure (Systolic,
Diastolic and mean) will be measured as baseline, after induction of
anaesthesia. Intraoperative monitoring will be continued. After completion of
surgery and administering the block, hemodynamic parameters noted and patient
will be shifted to ICU with endotracheal tube in situ. Extubation time,
monitoring of pulse rate, blood pressure SpO2, ECG, Respiratory rate and Modified
objective pain score (MOPS) will be recorded in ICU for 12 hours after surgery. |