| CTRI Number |
CTRI/2018/02/011763 [Registered on: 07/02/2018] 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 postoperative pain reducing anesthetic technique known as ultrasound guided erector spinae block in cardiac surgery in children. |
|
Scientific Title of Study
|
Safety and Effectiveness of Bilateral Erector Spinae Plane (ESP) Block in management of Acute Post operative surgical pain in pediatric cardiac surgeries via midline sternotomy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
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 |
|
| Fax |
|
| Email |
brajeshkaushal3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Debesh Bhoi |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Anesthesia, All India Institute of Medical Sciences, 4th floor main block, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
debeshbhoi@gmail.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 |
|
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Source of Monetary or Material Support
|
| Department Of Cardiac Anesthesia, C. N. Centre, AIIMS, Ansari Nagar, New Delhi. 110029 |
|
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Primary Sponsor
|
| Name |
Department of Cardiac Anesthesia |
| Address |
Cardiothoracic and Neuro science centre, 7 th floor, AIIMS Ansari Nagar, New Dellhi |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Brajesh Kaushal |
All India Institute of Medical Sciences |
Department of Cardiac Anesthesia,7th floor, C. N. Center, AIIMS, New Delhi
New Delhi
DELHI |
9425772151
brajeshkaushal3@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 |
Pediatric patients between age 6 months to 12 years, ASA Grade I or II with congenital heart diseases i.e. ASD, VSD, TOF, TAPVC, requiring elective sternotomy for surgical correction or repair. , (1) ICD-10 Condition: Q213||Tetralogy of Fallot, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous Opioid / non opioid Analgesics in standard doses. |
patients will be given i.v. analgesics (Paracetamol) as per standard doses (mg/kg) and inj. Fentanyl (µg/kg) will be used as rescue analgesic whenever required. |
| Intervention |
Ultrasound guided Erector Spinae Plane (ESP) Block |
Ultrasound guided erector spinae plane block will be performed after completion of the surgery and skin closure. Patient will be turned right/left lateral with vigilance about intact invasive lines. After skin disinfection, a high frequency linear ultrasound transducer (LII-1, Philips iE33, Bothell, USA) will be placed in a longitudinal orientation over the transverse process lateral to T5 spinous process. After identifying the three muscles above the hyperechoic transverse process shadow as trapezius, rhomboid major and erector spinae, an 5 cm 22-guage stimuplex block needle will be inserted in-plane in a cephalad to caudal direction. The endpoint will be needle pointing to the tip of trasverse process piercing the erector spinae muscle (at this position the LA will be deposited close to the costo-transverse foramen leading to better drug spread to dorsal and ventral rami). Needle tip position will be confirmed by hydrolocation with 0.5 to 1 ml of 2% lidocaine indicating linear fluid spread lifting the inter fascial plane between rhomboid major and erector spinae muscle. Then under continuous ultrasound guidance after careful negative aspiration, 2.5 mg/kg of 0.25% ropivacaine (half dose) will be injected. The same will be repeated on the contralateral side of T5 spinous process and the remaining half dose of the 2.5mg/kg of 0.25% ropivacaine will be injected. |
|
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Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
patients of either sex in the age group of 06 months -12 years, patients with congenital heart disease with normal LV function for elective surgery. |
|
| ExclusionCriteria |
| Details |
emergency surgery, redo surgery, moderate to severe LV dysfunction, bleeding disorder or abnormal coagulation profile, patients planned for thoracotomy. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the assessment of postoperative analgesia by the Modified Objective Pain Score (MOPS) and duration of postoperative analgesia of bilateral erector spinae plane block as compared to standard institutional practices. |
Modified Objective pain score assessed after extubation and the 2,4,6,8,10,12 hours after extubation |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To compare duration of mechanical ventilation, rescue analgesia (fentanyl) consumption / total opioid consumption and duration of ICU stay. |
Extubation time, monitoring of pulse rate, blood pressure SpO2, ECG, Respiratory rate, total fentanyl consumption, duration of mechanical ventilation and duration of ICU stay will be recorded every 2,4,6,8,10 and 12 hours. |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/12/2017 |
| Date of Study Completion (India) |
30/09/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Ultrasound
– guided Erector spinae Plane (ESP) block is a novel, yet simpler and promising
regional anesthetic technique for post-operative analgesia that produces an
extensive multidermatomal sensory block. The dorsal and ventral rami of the
thoracic spinal nerves along with rami communicantes are its site of action.
The ESP block, when given bilaterally at the level of T5 spinous process, provides complete
analgesia from T2-T9 sensory level for about 12 hours on average. Further, it is less invasive, safer, easier
and quicker to perform, with rare to very rare occurrence of complications like
pneumothorax. This block results in both somatic and
visceral analgesia3.
Thus, ESP block could provide adequate and
reliable analgesia for all the patients undergoing cardiac surgery via midline
sternotomy. Till date no research has been done regarding the role of ESP block
for postoperative analgesia in pediatric cardiac surgical patients.All preoperative cardiac
medication will be continued until the morning of surgery except antiplatelate,
anticoagulant drugs. Premedication for children > 5kg will consist of 0.1
mg/kg morphine and 0.5 mg/kg promethazine intramuscularly 1 hour before the
surgery. Children <5 kg receive no premedication as per institutional
protocol. 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 every 2 hours for 12 hours after surgery.
|