| CTRI Number |
CTRI/2025/10/096518 [Registered on: 28/10/2025] Trial Registered Prospectively |
| Last Modified On: |
25/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of regional analgesia techniques for providing postoperative analgesia following laparoscopic cholecystectomy |
|
Scientific Title of Study
|
A comparative evaluation of effectiveness of external oblique intercostal plane block and subcostal transversus abdominis plane block in enhancing post op analgesia in laparoscopic cholecystectomy. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DIVESH ARORA |
| Designation |
DIRECTOR AND HOD |
| Affiliation |
Asian Hospital Faridabad |
| Address |
OT Complex,3rd floor,Department of Anesthesia, Asian Hospital SECTOR 21 A, BADKAL FLYOVER ROAD,FARIDABAD
OT Complex,3rd floor,Department of Anesthesia, Asian Hospital,SECTOR 21 A, BADKAL FLYOVER ROAD,FARIDABAD
Faridabad
HARYANA
121002
India |
| Phone |
09650099113 |
| Fax |
|
| Email |
drdivesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KAUSHIKI NARAYAN |
| Designation |
PG STUDENT |
| Affiliation |
Asian Hospital Faridabad |
| Address |
OT Complex,3rd floor,Department of Anesthesia, Asian Hospital,SECTOR 21 A, BADKAL FLYOVER ROAD,FARIDABAD
OT Complex,3rd floor,Department of Anesthesia, Asian Hospital,SECTOR 21 A, BADKAL FLYOVER ROAD,FARIDABAD
HARYANA
121002
India |
| Phone |
9934181399 |
| Fax |
|
| Email |
kaushiki.narayan0201@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DIVESH ARORA |
| Designation |
DIRECTOR AND HOD |
| Affiliation |
Asian Hospital Faridabad |
| Address |
OT Complex,3rd floor,Department of Anesthesia, Asian Hospital,SECTOR 21 A, BADKAL FLYOVER ROAD,FARIDABAD
OT Complex,3rd floor,Department of Anesthesia, Asian Hospital,SECTOR 21 A, BADKAL FLYOVER ROAD,FARIDABAD
HARYANA
121002
India |
| Phone |
09650099113 |
| Fax |
|
| Email |
drdivesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| ASIAN HOSPITAL, Sector 21 A, Badkal Flyover Road, FARIDABAD-121002, Haryana, India. |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| DIVESH ARORA |
Asian Hospital Faridabad-121002 |
OT Complex,3rd floor, Department of Anesthesia, Asian Hospital,SECTOR 21 A, BADKAL FLYOVER ROAD,FARIDABAD
Faridabad
HARYANA |
09650099113
drdivesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTION ETHICS COMMIITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A
External Oblique Intercostal Plane Block (EOIB) |
Ultrasound-guided EOIB is given using 25 mls of 0.3% ropivacaine plus 8 mg dexamethasone. Local anesthetic is injected in plane between external oblique and intercostal muscles at 6th rib level |
| Comparator Agent |
Group B
Subcostal Transversus Abdominis Plane (TAP) Block |
Ultrasound-guided subcostal TAP block is given using 25 mls of 0.3% ropivacaine plus 8 mg dexamethasone. Injection is given in the plane between posterior rectus sheath and transversus abdominis muscle medial to Linea semilunaris and in between internal oblique and transversus abdominis lateral to Linea semilunaris |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18–60 years belonging to ASA I–II status, scheduled for elective laparoscopic cholecystectomy who provided written informed consent will be recruited for this trial |
|
| ExclusionCriteria |
| Details |
Patients who refuse to participate, who have Local infection at injection site, are known allergic to local anesthetic drugs, are having coagulopathy or receiving anticoagulant drugs, are pregnant or having neuromuscular and psychiatric disorders will be excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total tramadol consumption in first 24 postoperative hours |
Total tramadol consumption in first 24 postoperative hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intraoperative fentanyl requirement |
0, 2, 4, 8, 12, and 24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/11/2026 |
| 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 - NO
|
|
Brief Summary
|
This randomized, double-blind clinical study aims to compare the analgesic efficacy of the External Oblique Intercostal Plane (EOIB) block and the Subcostal Transversus Abdominis Plane (TAP) block in patients undergoing elective laparoscopic cholecystectomy. Sixty adult patients (ASA I–II, aged 18–60 years) will be randomly allocated into two equal groups to receive either EOIB or subcostal TAP block under ultrasound guidance, in addition to standard multimodal analgesia. The primary outcome is total tramadol consumption in the first 24 postoperative hours. Secondary outcomes include intraoperative fentanyl requirement, hemodynamic stability, time to first rescue analgesic, postoperative VAS pain scores, patient satisfaction, and incidence of nausea, vomiting, or sedation. Data will be analyzed using appropriate statistical methods with p < 0.05 considered significant.
This study seeks to determine which block provides superior postoperative analgesia and better patient comfort after laparoscopic cholecystectomy, thereby contributing to improved regional anesthesia practices in upper abdominal surgeries. |