| CTRI Number |
CTRI/2026/07/113242 [Registered on: 02/07/2026] Trial Registered Prospectively |
| Last Modified On: |
01/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare two pain relieving techniques after gallbladder surgery to know which works better |
|
Scientific Title of Study
|
Comparison of external oblique intercostal plane block and transversus abdominis plane block for postoperative 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 |
Sneha P V |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Kozhikode |
| Address |
Department of Anaesthesiology
Government Medical College, Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
9037981970 |
| Fax |
|
| Email |
snehaanishkumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishnadas A |
| Designation |
Professor (CAP) |
| Affiliation |
Government Medical College, Kozhikode |
| Address |
Department of Anaesthesiology
Government Medical College, Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
9447382969 |
| Fax |
|
| Email |
drakrishnadas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sneha P V |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Kozhikode |
| Address |
Department of Anaesthesiology
Government Medical College, Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
9037981970 |
| Fax |
|
| Email |
snehaanishkumar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Government Medical College, Kozhikode |
| Address |
Government Medical College, Kozhikode
Kerala, India
PIN: 673008 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Government Medical College Kozhikode |
Government Medical College, Kozhikode |
Department of Anaesthesiology
Major Operation theatre,
Government Medical College, Kozhikode
Kozhikode
KERALA |
04952350216
principalmcc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Medical College, Kozhikode |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
External Intercostal Plane Block |
Nerve block is given after induction of general anaesthesia. Postoperative pain and dermatology sensory level is assessed after extubation post anaesthesia care unit(PACU) and postoperative ward for 24hours. |
| Comparator Agent |
TAP block |
Nerve block is given after induction of general anaesthesia. Postoperative pain and dermatology sensory level is assessed after extubation post anaesthesia care unit(PACU) and postoperative ward for 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Posted for elective laparoscopic cholecystectomy under GA
ASA physical status 1&2 |
|
| ExclusionCriteria |
| Details |
Infection at injection site
Coagulopathy
BMI more than 35
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 |
1. To compare postoperative analgesia using Numeric Rating Scale between EOIC plane block versus TAP block in adult patient undergoing laparoscopic cholecystectomy
2. To assess the duration of postoperative analgesia in terms of time to first rescue analgesia
after surgery |
0 is on arrival to PACU
4 hours, 8 hours, 12 hours, 12 hours post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SECONDARY OBJECTIVE
1. To compare the postoperative rescue analgesic requirements over a 24-hour period
2. To determine the dermatomal level of sensory block in both groups |
0 is on arrival to PACU
4 hours, 8 hours, 12 hours, 12 hours post surgery |
|
|
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)
|
12/07/2026 |
| 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
|
A 60-patient quasi-experimental study comparing EOIC vs TAP block after laparoscopic cholecystectomy, evaluating postoperative pain scores, duration of analgesia, rescue analgesic consumption, and sensory block coverage.
|