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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  
Name  Address 
nil  nil 
 
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  
Status 
Not Applicable 
 
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
  1. 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).

  2. 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

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. 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.

  7. 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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