| CTRI Number |
CTRI/2025/08/092497 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the post operative pain relief in patients undergoing gall bladder surgery, provided by injecting local anaesthetic drugs at two different sites. |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of ultrasound guided external oblique intercostal plane block and subcostal
transverse abdominis plane block in patients undergoing laparoscopic cholecystectomy – A double blinded
randomised interventional trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aswini L |
| Designation |
Associate Professor |
| Affiliation |
Esic Medical College and Hospital |
| Address |
Modulat Ot, First floor, Dept.of anaesthesiology, Esic medical college and hospital, Ashok Pillar Road, KK nagar, Chennai.
Chennai
TAMIL NADU
600078
India |
| Phone |
9442011352 |
| Fax |
|
| Email |
aswinijipmer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aswini L |
| Designation |
Associate Professor |
| Affiliation |
Esic Medical College and Hospital |
| Address |
Modulat Ot, First floor, Dept.of anaesthesiology, Esic medical college and hospital, Ashok Pillar Road, KK nagar, Chennai.
Chennai
TAMIL NADU
600078
India |
| Phone |
9442011352 |
| Fax |
|
| Email |
aswinijipmer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aswini L |
| Designation |
Associate Professor |
| Affiliation |
Esic Medical College and Hospital |
| Address |
Modulat Ot, First floor, Dept.of anaesthesiology, Esic medical college and hospital, Ashok Pillar Road, KK nagar, Chennai.
Chennai
TAMIL NADU
600078
India |
| Phone |
9442011352 |
| Fax |
|
| Email |
aswinijipmer@gmail.com |
|
|
Source of Monetary or Material Support
|
| Esic Medical College and Hospital, KK Nagar, Chennai. |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| 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 |
| Aswini L |
Esic medical college and hospital, KK nagar, Chennai. |
Modular Ot, First floor, Dept. of Anaesthesiology, Esic medical college and hospital,Ashok Pillar Road, KK nagar
Chennai
TAMIL NADU |
9442011352
aswinijipmer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Esic medical College and Hospital |
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 intercostal plane block |
Ultrasound guided bilateral external oblique intercostal block using 20 ml of
0.25% ropivacaine |
| Comparator Agent |
Subcostal plane block |
Ultrasound guided bilateral transverse
abdominis plane block using 20 ml of 0.25% ropivacaine on each side |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Association
1 and 2
Patients undergoing laparoscopic cholecystectomy |
|
| ExclusionCriteria |
| Details |
Patients undergoing emergency surgeries,Revision or re-do surgeries, patients with
allergy to local anaesthetics, patients with coagulation disorders and patients
undergoing surgery due to infectious causes 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 and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the analgesic efficacy of subcostal transverse abdominis plane block and
external oblique intercostal plane block in patients undergoing laparoscopic
cholecystectomy. To compare the time for the first request of rescue analgesia post operatively between
the two groups. |
To compare the time for the first request of rescue analgesia post operatively between
the two groups. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Total opioid consumption between the two groups
2. Comparison of pain scores & postoperative comfort scores between the two
groups. |
1. In the first 24 hours after surgery.
2. At 0,4,8,12,24 hours |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
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="0"
Months="3"
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
|
Laparoscopic cholecystectomy is one of the most common upper abdominal surgeries. Pain after laparoscopic cholecystectomy is a hindering factor for early discharge of the patients. Use of opioids leads to unwanted side effects .External oblique intercostal plane block is a novel technique covering the anterior and lateral cutaneous branches of the intercostal nerves. This study is aimed to compare the post operative analgesic efficacy of two different plane blocks- subcostal transverse abdominis block and external oblique intercostal plane block. This block if successful will help in early discharge of the patients and will reduce the use of opioids. |