| CTRI Number |
CTRI/2026/02/103765 [Registered on: 12/02/2026] Trial Registered Prospectively |
| Last Modified On: |
12/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study comparing pain relief with two types of anaesthetic injection techniques in patients undergoing keyhole gall bladder removal surgery. |
|
Scientific Title of Study
|
A prospective randomised controlled trial on the postoperative analgesic efficacy of ultrasound guided external oblique intercostal plane block versus port site infiltration in patients undergoing 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 |
Dr Sruthy Suresh |
| Designation |
Assistant Professor |
| Affiliation |
Sree Uthradom Thirunal Academy Of Medical Sciences |
| Address |
Department of Anaesthesiology
Sree Uthradom Thirunal Academy Of Medical Sciences
Vencode
Vattapara
Thiruvananthapuram
Thiruvananthapuram
KERALA
695028
India |
| Phone |
9400791101 |
| Fax |
|
| Email |
drsruthykiran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sruthy Suresh |
| Designation |
Assistant Professor |
| Affiliation |
Sree Uthradom Thirunal Academy Of Medical Sciences |
| Address |
Department of Anaesthesiology
Sree Uthradom Thirunal Academy Of Medical Sciences
Vencode
Vattapara
Thiruvananthapuram
Thiruvananthapuram
KERALA
695028
India |
| Phone |
9400791101 |
| Fax |
|
| Email |
drsruthykiran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sruthy Suresh |
| Designation |
Assistant Professor |
| Affiliation |
Sree Uthradom Thirunal Academy Of Medical Sciences |
| Address |
Department of Anaesthesiology
Sree Uthradom Thirunal Academy Of Medical Sciences
Vencode
Vattapara
Thiruvananthapuram
Thiruvananthapuram
KERALA
695028
India |
| Phone |
9400791101 |
| Fax |
|
| Email |
drsruthykiran@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sree Uthradom Thirunal Academy Of Medical Sciences |
| Address |
Sree Uthradom Thirunal Academy Of Medical Sciences
Vencode , Vattappara
Thiruvananthapuram
695028 |
| Type of Sponsor |
Private 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 |
| Dr Bhaskar M K |
Sree Uthradom Thirunal Academy Of Medical Sciences |
Assistant professors’s room, Room no - 215,Department of Anaesthesiology,Operation Theatre
complex,Hospital block,
Vencode (p.o),Vattapara,Trivandrum
Pincode-695028
Thiruvananthapuram
KERALA |
8113005184
bhaskarmk2008@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SUTAMS-IEC |
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 |
Port-Site Infiltration |
Just before extubation, the surgeon will infiltrate 5 mL of 0.25 percentage bupivacaine at each of the four port sites using a 21G needle (total volume: 20 mL).
Drug-Bupivacaine percentage
Dose- 5 mL at each port site(Total 20ml)
Route- local infiltration at surgical port site
Frequency-single administration
Timing-At the end of surgery before extubation .
Total duration-single time infiltration. |
| Intervention |
Ultrasound-Guided External Oblique Intercostal Plane (EOIP) Block |
Before extubation and in supine position, under aseptic precautions,
a high-frequency linear ultrasound probe (12–15 MHz) will be placed obliquely over the 6th–7th rib medial to the anterior axillary line.
An in-plane technique will be used to advance the needle between the external oblique and intercostal muscles.
Following hydrodissection with saline, 25 mL of 0.25 percentage bupivacaine on each side will be injected into the fascial plane.
Dose- total 50 mL(bilaterally)
Drug- 0.25 percentage Bupivacaine
Route-fascial plane block
Frequency-single administration
Timing-given once at the end of surgery before extubation
Duration - single time block administered post surgery, before extubation.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA Physical Status class 1 and 2
Undergoing elective laparoscopic cholecystectomy
Providing written informed consent |
|
| ExclusionCriteria |
| Details |
Known allergy to local anesthetics
Coagulopathy or local infection at injection site
Chronic opioid use or major comorbid illnesses
Refusal to give consent |
|
|
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 |
| Pain scores using the NRS |
At 1 hour post extubation
2 hours post extubation
6 hours post extubation
12 hours post extubation
24 hours post extubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to first intravenous rescue analgesic
Total dose of IV analgesic required in 24 hours
Frequency of intravenous analgesia administration
Incidence of postoperative nausea & vomiting
Patient satisfaction score using Likert scale
|
Within first 24 hours post extubation |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/03/2026 |
| 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="2"
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
|
This study will be conducted as a prospective, parallel-arm, randomized controlled trial done for a period of two years , comparing the postoperative analgesic efficacy of ultrasound-guided external oblique intercostal plane (EOI) block with port-site infiltration in patients undergoing laparoscopic cholecystectomy. Eligible patients will be randomly assigned to either Group A (EOI block) or Group B (port-site infiltration) using a computer-generated random number sequence. Allocation concealment will be ensured through sealed opaque envelopes. The investigator performing postoperative assessments will be blinded to group allocation. The final sample size will be 20 participants per group (total 40).Primary Outcome measures Pain scores at 1, 2, 6, 12, and 24 hours using the NRS. Secondary Outcomes are time to first intravenous rescue analgesic,total dose of IV analgesic required in 24 hours,frequency of IV analgesia administration, incidence of postoperative nausea and vomiting (PONV) , patient satisfaction score (Likert scale). |