CTRI Number |
CTRI/2024/01/061958 [Registered on: 29/01/2024] Trial Registered Prospectively |
Last Modified On: |
23/01/2024 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Single Arm Study |
Public Title of Study
|
Modified thoracoabdominal nerve block with guidance of ultrasound by perichondrial approach for perioperative analgesia in paediatric patients posted for nephrectomy- A case series |
Scientific Title of Study
|
Ultrasound guided modified thoracoabdominal nerve block through perichondrial approach for perioperative analgesia in paediatric patients posted for nephrectomy- A case series |
Trial Acronym |
Nil |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
VIKASH KUMAR |
Designation |
|
Affiliation |
IGIMS, Patna |
Address |
Deptt of Anaesthesiology,IGIMS, 1st floor, Sheikhpura, Patna Deptt of Anaesthesiology,IGIMS, 1st floor, Sheikhpura, Patna Patna BIHAR 800004 India |
Phone |
8409697069 |
Fax |
|
Email |
vkskmc@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Swati |
Designation |
Additional Professor |
Affiliation |
IGIMS, Patna |
Address |
Deptt of Anaesthesiology,IGIMS, 1st floor, Sheikhpura, Patna
Patna BIHAR 800014 India |
Phone |
9113463130 |
Fax |
|
Email |
deepakswat@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Swati |
Designation |
Additional Professor |
Affiliation |
IGIMS, Patna |
Address |
Deptt of Anaesthesiology,IGIMS, 1st floor, Sheikhpura, Patna
Patna BIHAR 800014 India |
Phone |
9113463130 |
Fax |
|
Email |
deepakswat@yahoo.com |
|
Source of Monetary or Material Support
|
Vikash Kumar, Deptt of Anaesthesiology, first floor,IGIMS, Sheikhpura ,Patna, Bihar, 800014 |
|
Primary Sponsor
|
Name |
VIKASH KUMAR |
Address |
Deptt of Anaesthesiology,IGIMS, 1st floor, Sheikhpura, Patna |
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 |
Vikash Kumar |
Paediatrics Surgery OT |
Paediatrics Surgery OT, 1st floor, IGIMS, Patna Patna BIHAR |
8409697069
vkskmc@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: N288||Other specified disorders of kidney and ureter, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Modified thoracoabdominal nerve block through perichondrial approach for perioperative analgesia in paediatric patients |
Ultrasound guided modified thoracoabdominal nerve block through perichondrial approach for perioperative analgesia in paediatric patients posted for nephrectomy |
Comparator Agent |
Modified thoracoabdominal nerve block through perichondrial approach for perioperative analgesia in paediatric patients |
Ultrasound guided modified thoracoabdominal nerve block through perichondrial approach for perioperative analgesia in paediatric patients posted for nephrectomy |
|
Inclusion Criteria
|
Age From |
2.00 Year(s) |
Age To |
15.00 Year(s) |
Gender |
Both |
Details |
• Patients of ASA physical status 1,2
• Patients between 2-15 years of age of either sex posted for nephrectomy
• Patient attendant able to comprehend and willing to participate
• Patients scheduled for general elective
surgeries
|
|
ExclusionCriteria |
Details |
• Patients attendant who refuse to participate
• Patients allergic to bupivacaine
• Patients having infection at drug
administration site
• Patients having coagulopathy
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
The primary objective of the study will be to evaluate the need for first rescue analgesia in the first postoperative 24 h in patients |
The primary objective of the study will be to evaluate the need for first rescue analgesia in the first postoperative 24 h in patients |
|
Secondary Outcome
|
Outcome |
TimePoints |
To measure hemodynamics of the patient |
Upto 24 hour postoperatively |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
01/02/2024 |
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="0" Months="6" 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
|
This study will be conducted after
institutional ethical committee approval and Clinical Trials Registry India
(CTRI) registration. Written informed consent of patient will be taken.
Standard monitoring
with electrocardiography, non-invasive blood pressure, capnography, a multi-gas
analyser, and peripheral oxygen saturation will be performed on all patients in
the operating room. Mechanical ventilation will be achieved using a
pressure-controlled mode to maintain end-tidal carbon dioxide at 35 to
40 mm Hg. Depth of anaesthesia will be controlled during surgery using
end-tidal sevoflurane and maintaining the sevoflurane concentration (0.8-1MAC).
M-TAPA will be administered bilaterally by a single anaesthesiologist after the
induction of general anaesthesia before the surgical procedure.
Anaesthesia induction and endotracheal intubation will
be performed intravenously using
propofol 2 mg/kg, fentanyl 1-2 µg/kg, and atracurium 0.5 mg/kg.
Anaesthesia will be maintained with sevoflurane and oxygen and nitrous oxide.
M-TAPA technique- M-TAPA will be performed bilaterally by a
single anaesthesiologist, as described by Tulgar et al. Following the tracheal
intubation and before the surgical procedure, transversus abdominis, internal
oblique, and external oblique muscles were identified with a high-frequency
(12 MHz) linear probe on the costochondral angle in the sagittal plane
under ultrasound guidance at the 10th costal margin. A deep angle will be given
to the costochondral angle at the edge of the 10th costa with the probe in the
sagittal direction to view the lower surface of the costal cartilage in the
midline. A 21-G, 80-mm block needle was inserted in the cranial direction using
the in-plane technique and the needle tip will be moved to the posterior aspect
of the 10th costal cartilage. It will be noted that the needle tip never
crossed the cranial edge of the 10th costal cartilage and 25 mL of 0.25%
bupivacaine will be injected into the lower surface of the chondrium. The same
process will be repeated for the other side.
The primary objective of the study will be to evaluate the
need for first rescue analgesia in the first postoperative 24 h in
patients with and without M-TAPA block. Pain severity will be measured using CHEOPS
scale and FLACCS scale. Both will be recorded postoperatively at 0 and 2, 6, 12
hrs. If FLACC score above 4 rescue analgesic will be given.
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