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CTRI Number  CTRI/2023/03/050617 [Registered on: 13/03/2023] Trial Registered Prospectively
Last Modified On: 13/03/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of interfacial plane block for upper abdominal surgery in pediatric population. 
Scientific Title of Study   Comparison of ultrasound‐guided erector spinae plane block vs modified thoracoabdominal nerve block through perichondrial approach for perioperative analgesia in paediatric patients undergoing upper abdominal surgery: a randomized controlled trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amarjeet Kumar 
Designation  Associate Professor 
Affiliation  AIIMS, Patna 
Address  Department of Anaesthesia, Room no 505, B Block, OT Complex

Patna
BIHAR
801507
India 
Phone  9570890646  
Fax    
Email  amarjeetdmch@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Amarjeet Kumar 
Designation  Associate Professor 
Affiliation  AIIMS, Patna 
Address  Department of Anaesthesia, Room no 505, B Block, OT Complex


BIHAR
801507
India 
Phone  9570890646  
Fax    
Email  amarjeetdmch@gmail.com  
 
Details of Contact Person
Public Query  
Name  Amarjeet Kumar 
Designation  Associate Professor 
Affiliation  AIIMS, Patna 
Address  Department of Anaesthesia, Room no 505, B Block, OT Complex


BIHAR
801507
India 
Phone  9570890646  
Fax    
Email  amarjeetdmch@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, AIIMS, Patna, Phulwarisharif, Bihar, India 
 
Primary Sponsor  
Name  AIIMS Patna 
Address  Department of Anaesthesia, B-Block, OT complex 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
AIIMS Patna  Department of Anaesthesia, B-Block, OT Complex 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Amarjeet Kumar  AIIMS Patna  Department of Anaesthesia, B-Block, OT complex Patna, BIHAR
Patna
BIHAR 		 9570890646

amarjeetdmch@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC AIIMS, Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Erector spinae plane (ESP) block   ESP block will be performed lateral position at the level of T7 transverse process. Under the aseptic precautions a high frequency (6-13MHz) linear probe (footprint size 4cm) will be placed longitudinally (parasagittal plane) parallel to the vertebral axis. After identifying the three muscles trapezius, rhomboid major, and erector spinae superficial to the hyperechoic transverse process, the block will be performed using 22-gauge 5cm echogenic needle. total duration of procedure will take 10 minutes Skin incision will be allowed 15 minutes after the injection of study solutions. 
Comparator Agent  Modified thoracoabdominal nerve block through perichondrial approach (mTAPA block)  mTAPA block will be performed in supine position at the level of 9th costal cartilage. Under the aseptic precautions a high frequency (6-13MHz) linear probe (footprint size 4cm, M‑Turbo, Fujifilm Sonosite, Inc, Bothell, WA, USA) will be placed longitudinally (sagittal plane) on the costochondral angle of operating side. The angle of the probe is to be deepened to view the lower aspect of the chondrium in the midline. The block will be performed using 22-gauge 5cm echogenic needle. The needle will be inserted in-plane to the probe in caudal to cephalad direction to target lower aspect of chondrium. Total duration of procedure will take 10 minutes. Skin incision will be allowed 15 minutes after the injection of study solutions. 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  ASA I and II patients scheduled for upper abdominal surgeries through unilateral upper quadrant incision 
 
ExclusionCriteria 
Details  1. Parents refusal to participate in the study
2. Patients with coagulation disorders
3. Patients hypersensitive to study medications
4. Patients with developmental or mental delay
5. Skin lesions or infection at the planned site of needle insertion
6. Subcostal incision extended to opposite side.
7. Patient develop complication (surgical/Anaesthesia) or re-exploration within 24 hours will be excluded from analysis.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Intraoperative fentanyl consumption  Total fentanyl consumption during intaoperative period.  
 
Secondary Outcome  
Outcome  TimePoints 
1. Postoperative pain score using CHEOPS (Children’s Hospital of Eastern Ontario Pain Scale)
2. To estimate postoperative paracetamol consumption
3. To determine time to first rescue analgesic administration
4. Side effect likes nausea, vomiting and sedation and local anesthetic toxicity
 		 pain score at 1, 4, 8, 16, 24 hours at rest. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   13/03/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Upper abdominal surgeries are very commonly done surgical procedure in pediatric population. Perioperative pain management in major abdominal surgeries remain a challenge. Adequate pain control reduces postoperative respiratory dysfunction and promote early mobilisation. Among the various nerve blocks available, ESP and mTAPA block are relatively newer regional anaesthetic technique. 
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