| CTRI Number |
CTRI/2023/09/058140 [Registered on: 29/09/2023] Trial Registered Prospectively |
| Last Modified On: |
27/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effectiveness of ultrasound guided two different block given in the muscle plane of thorax in pediatric cardiac surgery |
|
Scientific Title of Study
|
Comparing The Efficacy of Ultrasound Guided Bilateral-transverses Thoracic Plane Block Versus Bilateral Thoracic Paravertebral Block in Elective Pediatric Cardiac Surgery Patients - A Randomised Study |
| 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 Padma S |
| Designation |
Junior Consultant |
| Affiliation |
Sri Sathya Sai Institute Of Higher Medical Sciences, Whitefield |
| Address |
Dept of Anaesthesiology,
Sri Sathya Sai Institute Of Higher Medical Sciences,
Whitefield,
Bangalore-560066
Bangalore
KARNATAKA
560066
India |
| Phone |
9164546121 |
| Fax |
|
| Email |
drpadma2007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Padma S |
| Designation |
Junior Consultant |
| Affiliation |
Sri Sathya Sai Institute Of Higher Medical Sciences, Whitefield |
| Address |
Dept of Anaesthesiology,
Sri Sathya Sai Institute Of Higher Medical Sciences,
Whitefield,
Bangalore-560066
Bangalore
KARNATAKA
560066
India |
| Phone |
9164546121 |
| Fax |
|
| Email |
drpadma2007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Padma S |
| Designation |
Junior Consultant |
| Affiliation |
Sri Sathya Sai Institute Of Higher Medical Sciences, Whitefield |
| Address |
Dept of Anaesthesiology,
Sri Sathya Sai Institute Of Higher Medical Sciences,
Whitefield,
Bangalore-560066
Bangalore
KARNATAKA
560066
India |
| Phone |
9164546121 |
| Fax |
|
| Email |
drpadma2007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sathya Sai Instiute of Higher Medical Science, Whitefield, Bengaluru |
|
|
Primary Sponsor
|
| Name |
Dr Padma S |
| Address |
Junior Consultant,
Dept of Anaesthesia,
SSSIHMS,
Whitefield,
Bangalore, Karnataka |
| Type of Sponsor |
Other [SELF] |
|
|
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 Padma S |
SRI SATHYA SAI INSTITUTE OF HIGHER MEDICAL SCIENCES, WHITEFIELD, BENGALURU |
Cardiac Operation Theater complex (All OTs included) and Cardiac Intensive care Unit
Bangalore
KARNATAKA |
9164546121
drpadma2007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sathya Sai Institute of Higher Medical Sciences, Whitefield |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I95-I99||Other and unspecified disorders of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group T: Patients will receive USG guided bilateral Transverse thoracic plane block (TTPB) with 0.4ml /kg of 0.25% bupivacaine (2mg/kg) and fentanyl 2mcg/ml on either side. |
Bilateral TTPB will be carried using a 6-13MHz linear transducer probe. The probe is placed in the longitudinal plane 1cm lateral to sternal border and T4-T5 intercostal space is identified. A parasternal sagittal view of the internal intercostal muscle and the transversus thoracis muscle will be visualized between the fourth and fifth rib above the pleura. A 22G 38mm needle will be inserted in plane to the transducer with the tip of the needle located in the Transversus Thoracic Plane between the internal intercostal and transversus thoracic muscles. Hydrodissection will be performed by injecting 1 mL of normal saline between the internal intercostal and transversus thoracic muscles. Once the plane is delineated and ruling out intravascular and intrapleural placement, the drug mixture (containing 0.25%bupivacaine with 2mcg/ml of fentanyl) will be administered in aliquots with intermittent negative aspiration. Further widening of the plane, spread of the local anesthetic injection, depression of the pleura confirms the proper placement of needle. This procedure will be repeated on the contralateral side. |
| Comparator Agent |
Group P: Patients will be given USG guided bilateral paravertebral block (PVB) using 0.4ml/kg of 0.25% bupivacaine (2mg/kg) and fentanyl 2mcg/ml on either side. |
The patient will be placed in the right lateral position. Ultrasound-guided PVB will be performed with the probe placed sagittal on the paravertebral area using in plain technique. The ribs, spinous, and transverse processes of the vertebra, costotransverse joints, and pleura are used as sonographic landmarks. A 22G 38mm needle will be inserted in plane to the transducer with the tip of the needle in the paravertebral space, with negative aspiration for blood and air the drug mixture (0.25%bupivacaine with fentanyl 2mcg/ml) will be administered with intermittent negative aspiration, the injection of the local anesthetic will be visualized in real-time and confirmed with pleural depression. This procedure will be repeated on the contralateral side. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.All patients Aged 1year to 12 years of age.
2.ASA grade II.
3.All pediatric patients scheduled for elective cardiac surgery via median sternotomy.
4.Patients planned for early extubation
|
|
| ExclusionCriteria |
| Details |
1.Parental refusal for the study.
2.Patients with pectus excavatum and carinatum.
3.Patients with documented local anesthetic and opioid allergy.
4.Patients scheduled for emergency surgeries and nonmedian sternotomy procedures.
5.Patients preoperatively intubated
6.Patients planned postoperative ventilation greater than 12 hours
7.Patients planned for complex cardiac surgeries( Risk Adjustment for Congenital Heart Surgery (RACHS-1) score >3 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assess & compare hemodynamic parameters (heart rate, systolic and diastolic blood pressure, mean arterial blood pressure) and peri operative opoid requirement to incision and sternotomy |
Baseline, after induction, after block, 10th , 20th and 30th min after block, after incision, after sternotomy, post Cardio Pulmonary Bypass and last after skin closure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparing time taken for extubation, pain assessment, length of ICU stay |
Hourly for 24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/10/2023 |
| 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="0"
Months="9"
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
|
Median sternotomy in cardiac surgery is very painful. Hence need of regional block which can spare opoid use specially in pediatric age group. Hence we are comparing two truncal blocks and its post operative opoid requirements along with intra op hemodynamic changes, pain score in the ICU stay. Here we are comparing Ultrasound guided Paravertebral block and Transversus thoracic plane block containing Bupivacaine and fentanyl. The results will be analysed and discussed. |