| CTRI Number |
CTRI/2025/12/099549 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Medical procedure] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing postoperative pain control of External oblique intercostal plane block versus Modified thoracoabdominal nerve block via the perichondrial approach after upper abdominal surgery |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of ultrasound guided external oblique intercostal plane block and modified thoracoabdominal nerve block via perichondrial approach in patients undergoing upper abdominal surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divyashree R |
| Designation |
Senior Resident |
| Affiliation |
Sri Siddhartha Medical College |
| Address |
Department of Anaesthesiology, Major OT complex, Sri Siddhartha Medical College, Agalakote, B H road
TUMKUR
Tumkur
KARNATAKA
572107
India |
| Phone |
7892708987 |
| Fax |
|
| Email |
divyashree0545@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Divyashree R |
| Designation |
Senior Resident |
| Affiliation |
Sri Siddhartha Medical College |
| Address |
Department of Anaesthesiology, Major OT complex, Sri Siddhartha Medical College, Agalakote, B H road
TUMKUR
Tumkur
KARNATAKA
572107
India |
| Phone |
7892708987 |
| Fax |
|
| Email |
divyashree0545@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Divyashree R |
| Designation |
Senior Resident |
| Affiliation |
Sri Siddhartha Medical College |
| Address |
Department of Anaesthesiology, Major OT complex, Sri Siddhartha Medical College, Agalakote, B H road
TUMKUR
KARNATAKA
572107
India |
| Phone |
7892708987 |
| Fax |
|
| Email |
divyashree0545@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Siddhartha Medical College |
|
|
Primary Sponsor
|
| Name |
Dr Divyashree R |
| Address |
Senior resident, Department of Anaesthesiology, Major OT complex, Sri Siddhartha Medical College, Agalakote, B H road
TUMKUR |
| 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 |
| Dr Divyashree R |
Sri Siddhartha Medical College |
Department of Anaesthesiology, Major OT complex, Sri Siddhartha Medical College, Agalakote, B H road
TUMKUR
Tumkur
KARNATAKA |
7892708987
divyashree0545@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 |
| Healthy Human Volunteers |
Pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
External oblique intercostal plane block |
At the level of 6th rib in mid clavicular line under ultrasound guidance |
| Intervention |
Modified thoracoabdominal nerve block via the perichondrial approach |
At the level of 10th costal margin in the anterior axillary line under ultrasound guidance |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA1,2,3 |
|
| ExclusionCriteria |
| Details |
Refusal to participate in the study, second surgery at the same site, mental retardation,metabolic disorders, antidepressant, diathesis,body mass index (BMI) above 35kg/m2,
Preoperative liver or kidney dysfunction,Severe cardiac or respiratory disease, High prothrombin time abnormal or activated partial thromboplastin time, History of allergy to local anaesthetics
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To record Numerical rating scores for pain assessment post block
|
At 2nd hour, 4th hour, 6th hour, 12th hour, 24th hour post block
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Resue analgesic requirements |
At 4th hour, 12th hour, 24th hour |
| Sensory block distribution |
At 2nd hour |
| Side effects |
At 2nd hour, 4th hour, 6th hour, 12th hour, 24th hour |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
15/01/2026 |
| 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 Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [divyashree0545@gmail.com].
- For how long will this data be available start date provided 15-08-2026 and end date provided 31-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Various regional anesthesia techniques can be used to provide analgesia after abdominal surgery. While thoracic epidural anesthesia can be used, fascial plane blocks are favored as contemporary analgesic approaches. The thoracoabdominal nerves, also known as the T7–T12 thoracic intercostal nerves, innervate the abdominal wall muscles, parietal peritoneum, and skin. Postoperative pain following abdominal surgeries can arise from various causes. Multimodal analgesia methods are frequently used for the treatment of postoperative pain in different regions. Currently regional anesthesia techniques, particularly field blocks are typically used as multimodal analgesia. Various versions of Quadratus lumborum block, Erector spinae plane block, TAP block are used as regional anesthesia methods. Though QLB, ESP block targets both anterior and lateral cutaneous nerves, positioning and deep application area limits the use of such blocks. The inability of TAP block techniques to block the lateral and anterior areas of the upper abdominal region has prompted exploration of External oblique intercostal plane block, m- TAPA block, EXORA blocks. These blocks need further studies to know the vastness of its application and safety limits, hence present study is been carried out.
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