| CTRI Number |
CTRI/2025/07/091488 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two nerve blocks to reduce Pain after Gall bladder removal surgery |
|
Scientific Title of Study
|
Comparison of Analgesic Efficacy of USG Guided External Oblique Intercostal Plane block vs Subcostal Transversus Abdominis Plane Block in Patients Undergoing Elective Laparoscopic Cholecystectomy Randomised Controlled 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 |
Dr Akhil Kumar G |
| Designation |
Postgraduate Resident |
| Affiliation |
Ballari Medical College and Research Centre |
| Address |
G Akhil Kumar,Post Graduate resident ,
Dept of Anesthesiology,
Ballari Medical College and Research Centre,
Ballari.
Bellary KARNATAKA 583104 India |
| Phone |
8247886059 |
| Fax |
|
| Email |
joshuvaakhil@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anuradha H |
| Designation |
Associate professor |
| Affiliation |
Ballari Medical College and Research Centre |
| Address |
Dr Anuradha H ,Associate Professor in Department of Anaesthesiology BMCRC ,Ballari, Karnataka
Bellary KARNATAKA 583104 India |
| Phone |
8095106846 |
| Fax |
|
| Email |
hanuradha19@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Anuradha H |
| Designation |
Associate professor |
| Affiliation |
Ballari Medical College and Research Centre |
| Address |
Dr Anuradha H ,
Associate professor in Department of Anaesthesiology BMCRC , Ballari ,Karnataka
Bellary KARNATAKA 583104 India |
| Phone |
8095106846 |
| Fax |
|
| Email |
hanuradha19@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Ballari Medical College and Research Centre, Ballari,Karnataka, India ,583104 |
|
|
Primary Sponsor
|
| Name |
Ballari Medical College and Research Centre Ballari |
| Address |
Post graduate in MD anesthesia department of anaesthesiology BMCRC,Ballari ,Karnataka, India ,583104 |
| 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 |
| Dr Akhil |
Bellary medical college and research centre |
Department of Anesthesiology, new OT complex , Bellary, Karnataka Bellary KARNATAKA |
8247886059
joshuvaakhil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,Ballari Medical College and Research Centre, Ballari |
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 |
Comparative study to evaluate analgesic efficacy by using injection bupivacaine 0.25 % in laparoscopic cholecystectomy. |
Tap block vs Eoip block by using 0.25% bupivacaine 20 ml + 3 ml ns through usg guided and observed over 24 hours |
| Intervention |
Comparative study to evaluate analgesic efficacy by using injection bupivacaine 0.25 % in laparoscopic cholecystectomy. |
Tap block vs Eoip block by using 0.25% bupivacaine 20 ml + 3 ml ns through usg guided and observed over 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients who will be under going elective laparoscopic cholecystectomy done under general anaesthesia ASA 1 and 2 between 18 t0 60 years |
|
| ExclusionCriteria |
| Details |
Patient refusal for procedure
Patients with derange coagulation profile
Patient with puncture site infection
History of allergy to local anesthetic/study drugs
Neuromuscular diseases |
|
|
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 time to first rescue analgesia between External oblique intercostal plane block and subcostal Transversus abdominis plane block in patients undergoing laparoscopic cholecystectomy |
Duration of post operative analgesia after 4 hours, 8 hours, 12 hours,18 hours, 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare postoperative pain scores between patients receiving EOIP block and those receiving TAP block at various time intervals.
The amount of Tramadol consumption in the first 24 post operative hours.
Intraoperative vital signs including MAP and HR before and after surgical incision, after one hour, and at the end of surgery.
Incidence of shoulder tip pain
PONV Shivering and adverse effects associated with either block technique |
4 HOURS
8 HOURS
12 HOURS
18 HOURS
24 HOURS
|
|
|
Target Sample Size
|
Total Sample Size="48" Sample Size from India="48"
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 4 |
|
Date of First Enrollment (India)
|
14/08/2025 |
| 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="6" 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 13-03-2028 and end date provided 13-03-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Title
"COMPARISON OF ANALGESIC EFFICACY OF USG GUIDED EXTERNAL OBLIQUE INTERCOSTAL PLANE BLOCK VS SUBCOSTAL TRANSVERSUS ABDOMINIS PLANE BLOCK IN PATIENTS UNDERGOING ELECTIVE LAPAROSCOPIC CHOLECYSTECTOMY: RANDOMISED CONTROLLED STUDY"
Need for Study/Introduction
Laparoscopically performed Cholecystectomy is the corner stone of modern surgical practice as it speeds up post operative recovery. Even if LC is a minimally invasive procedure, patients may experience severe pain the postoperative period. Such pain can occur due to inflammation as result of surgical trauma, muscle and soft tissue trauma caused by port entry sites, insufflation of the abdominal cavity with carbon dioxide and trauma to the liver caused by dissection of the gall bladder. Inadequate analgesia in LC has implications for post operative pain management and patient recovery, as it can lead to delayed mobilization and a longer hospitalization period. In our institution we use inj. Fentanyl 2 mcg/kg, inj. Paracetamol 15 mg/kg IV infusion, local port site infiltration for analgesia. PROSPECT guidelines recommend truncal blocks for post-LC analgesia Regional anaesthesia technique have increasingly become essential components of multimodal analgesia, providing targeted pain relief while minimizing systemic opioid requirements. Despite promising preliminary data, there remains a paucity of direct comparative studies evaluating the efficacy of EOIP versus TAP blocks in Laparoscopic Cholecystectomy surgeries. A rigorous assessment of these two techniques is necessary to determine the most effective and reliable regional block for optimizing postoperative pain control in this patient population
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