| CTRI Number |
CTRI/2025/08/092548 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparison of pain reducing ability of external oblique intercoastal plane block with transversus abdominis plane block in upper abdominal surgeries |
|
Scientific Title of Study
|
A Comparison of analgesic efficacy of ultrasound-guided external oblique intercostal plane block and subcostal transversus abdominis plane block, in patients undergoing upper abdominal surgery. |
| 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 Shrey Kumar Dubey |
| Designation |
DNB trainee, Department of Anaesthesiology |
| Affiliation |
Shija Hospitals and Research Institute, Imphal |
| Address |
Department of Anaesthesiology and Critical care, 1st Floor, Eastern block, Shija Hospitals and Research Institute, Langol, Imphal
Imphal West
MANIPUR
795004
India |
| Phone |
7972907395 |
| Fax |
|
| Email |
skdubey718@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T. Kennedy Singh |
| Designation |
Sr. Consultant, Department of Anaesthesiology |
| Affiliation |
Shija Hospitals and Research Institute, Imphal |
| Address |
Department of Anaesthesiology, First Floor, Eastern Block, Shija Hospitals and Research Institute, Langol, Imphal
Imphal West
MANIPUR
795004
India |
| Phone |
9862342821 |
| Fax |
|
| Email |
t.kennedysinghdr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shrey Kumar Dubey |
| Designation |
DNB trainee, Department of Anaesthesiology |
| Affiliation |
Shija Hospitals and Research Institute, Imphal |
| Address |
Department of Anaesthesiology, First Floor, Eastern block, Shija Hospitals and Research Institute, Langol, Imphal
Imphal West
MANIPUR
795004
India |
| Phone |
7972907395 |
| Fax |
|
| Email |
skdubey718@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr T Kennedy Singh |
| Address |
Shija Hospitals and Research Institute Imphal |
| Type of Sponsor |
Other [Self] |
|
|
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 Shrey Kumar Dubey |
Shija Hospitals and Research Institute, Imphal |
Department of Anaesthesiology and Critical care, 1st Floor Eastern block, Shija Hospitals and Research Institute,Langol, Imphal
Imphal West
MANIPUR |
7972907395
skdubey718@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Shija academy of health sciences, Imphal |
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 |
| Intervention |
External oblique inrercostal muscle plane block |
25ml of 0.2% Ropivacaine will be injected under ultrasound guidance in the interfascial plane before the surgical incision but after the induction of general anaesthesia |
| Comparator Agent |
Subcostal transversus abdominis plane block |
25ml of 0.2% Ropivacaine will be given under ultrasound guidance in the interfascial plane before the incision for surgery but after induction of anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I/II
BMI 20-30kg/m² |
|
| ExclusionCriteria |
| Details |
Allergy to local Anaesthetics
Refusal to participate
On chronic pain therapy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To check the time to rescue analgesia in different approaches |
30 mins, 1 hour, 2 hour, 4 hour, 6 hours, 12 hours, and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| We will also measure the total amount of opioid consumed in. intraoperative & postoperative period |
1 day |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/08/2025 |
| 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 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 - NO
|
|
Brief Summary
|
Early postoperative pain that is not adequately managed reduces the quality of recovery and raises the possibility of pulmonary issues following operative procedures, which is a risk factor for the development of chronic pain. The External oblique intercostal plane block is a unique fascial plane block modification that might successfully cover the upper lateral abdomen. In addition to External oblique intercostal plane block’s possible analgesic effectiveness, anticoagulated patients have a significantly decreased risk due to its remote access point from vascular structures. In addition, the block’s superficial technique is preferable to conventional regional operations for obese individuals. For patients experiencing acute pain, the option to put a catheter away from the surgery site without requiring specific patient positioning is also advantageous. In the present study we are comparing the analgesic efficacy of ultrasound-guided external oblique intercostal plane block and ultrasound guided subcostal transversus abdominis plane block, in patients undergoing upper abdominal surgery with subcoastal supraumbilical incisions.
|