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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 Âµg/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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