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CTRI Number  CTRI/2025/08/092940 [Registered on: 12/08/2025] Trial Registered Prospectively
Last Modified On: 11/08/2025
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 pain relief with two types of regional blocks ( ultrasound assisted external oblique intercostal plane block vs erector spinae plane block) in children undergoing upper abdominal surgery 
Scientific Title of Study   Comparison of analgesic efficacy of ultrasound guided external oblique intercostal plane block and erector spinae plane block for paediatric patients undergoing upper abdominal surgery a randomised contolled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashish Kumar 
Designation  Senior resident 
Affiliation  All India Institute Of Medical Science Patna Phulwarisharif Patna Bihar India 
Address  B5A OT complex IPD building Department of anaesthesiology All India Institute of Medical sciences, Patna Phulwarisharif Patna 801507

Patna
BIHAR
801507
India 
Phone  8757935290  
Fax    
Email  akmodi009@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shagufta Naaz 
Designation  Additional Professor 
Affiliation  All India Institute Of Medical Science Patna Phulwarisharif Patna Bihar India 
Address  B5A OT complex IPD building Department of anaesthesiology All India Institute of Medical sciences Patna Phulwarisharif Patna BIHAR India

Patna
BIHAR
801507
India 
Phone  7838117314  
Fax    
Email  drshaguftanaaz@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ashish Kumar 
Designation  Senior resident 
Affiliation  All India Institute Of Medical Science Patna Phulwarisharif Patna Bihar India 
Address  B5A OT complex IPD building Department of anaesthesiology All India Institute of Medical sciences, Patna Phulwarisharif Patna 801507

Patna
BIHAR
801507
India 
Phone  8757935290  
Fax    
Email  akmodi009@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Patna Bihar 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Patna Bihar 
Address  All India Institute of Medical Sciences Patna Phulwarisharif 801507  
Type of Sponsor  Research institution and hospital 
 
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 
Ashish Kumar  All India institute of medical sciences , patna  Department of anaesthesiology, OT 17 OT complex ipd building All India institute of medical sciences patna Patna BIHAR 801507
Patna
BIHAR 
8757935290

akmodi009@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
THE INSTITUTE ETHICS COMMITTEE ALL INDIA INSTITUTE OF MEDICAL SCIENCES 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 
Comparator Agent  erector spinae plane block  single injection of 0.5 ml/kg 0.2% ropivacaine after induction 
Intervention  External oblique intercostal plane block  single injection of 0.5 ml/kg 0.2% ropivacaine after induction  
 
Inclusion Criteria  
Age From  8.00 Month(s)
Age To  8.00 Year(s)
Gender  Both 
Details  Patients aged 8 months to 8 years ASA I and II scheduled for upper abdominal surgeries 
 
ExclusionCriteria 
Details  Parent refusal to participate in the study.
Patients with coagulation disorders.
Patients hypersensitive to study medications.
Patients with developmental or mental delay.
Skin lesions or infection at the planned site of needle insertion
6.Congenital vertebral anomalies 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the post operative 24 hour opioid consumption  To compare the post operative 24 hour opioid consumption 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the time of first rescue analgesic administration  From the time of administration of block to the first need of use of analgesic administration 
To compare intra operative opioid consumption  From the time of administration of block to the end of the surgery 
To measure the average pain using MOPS score at 24 hour post operative period.  30 minutes, 2 hour, 4 hour, 6 hour, 12 hour, 24 hour 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
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)   25/08/2025 
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="1"
Months="0"
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  
Upper abdominal surgeries often involve various incisions, such as subcostal, inverted L-shaped, vertical, transverse, and oblique, which can lead to significant postoperative pain1. Effective pain management is crucial for ensuring early mobilization and a smooth recovery. Regional anaesthesia techniques are integral to perioperative care, forming a key component of multimodal pain management strategies that help reduce reliance on opioids and their side effects.
Traditionally, the thoracic epidural block has been the gold standard for pain relief in abdominal surgeries due to its superior analgesic properties. However, it comes with potential complications, including sympathetic blockade, hypotension, and rare but serious risks like epidural hematoma or spinal cord compression. These concerns are heightened in patients with coagulopathy or those undergoing extensive procedures.
Recently, the Erector Spinae Plane Block (ESPB) has gained prominence as a promising alternative for managing postoperative pain in abdominal surgeries. It offers effective pain relief while avoiding many complications associated with thoracic epidural analgesia. Similarly, superficial interfascial blocks are becoming increasingly popular in clinical practice due to their simplicity, ease of administration, and safety, particularly in patients where repositioning or coagulopathy is a concern.
Among these newer techniques, the External Oblique Intercostal (EOIPB) Block is attracting attention. This block targets the anterior and lateral cutaneous branches of the intercostal nerves and has demonstrated positive outcomes in various upper abdominal surgeries, including hepatic resections, open cholecystectomies, and pancreatic procedures.
This study aims to conduct a randomized clinical trial comparing the analgesic efficacy of ultrasound-guided External Oblique Intercostal Plane Block and Erector Spinae Plane Block. These techniques will be evaluated as part of a multimodal analgesia plan for patients undergoing upper abdominal surgeries with unilateral subcostal incisions. The trial will assess these blocks in terms of pain control, reduction in opioid usage, patient satisfaction, and overall safety.
 
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