| 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
|
|
|
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
|
|
|
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. |