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CTRI Number  CTRI/2025/08/093091 [Registered on: 14/08/2025] Trial Registered Prospectively
Last Modified On: 13/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   using USG in laparoscopic cholecystectomy to compare posterior and subcostal Transverse abdominis plane block 
Scientific Title of Study   Comparison of efficacy of posterior and subcostal techniques of ultrasound-guided transverse abdominis plane block in laparoscopic cholecystectomy-Randomized double-blinded study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  G P Kirankumar  
Designation  Post graduate 
Affiliation  Sri Manakula vinayagar medical college and hospital 
Address  Room no 109 Hospital 1st floor Department of anaesthesiology Sri manakula vinayagar medical college and hospital Kalitheerthalkuppam Puducherry 605107
Room no 109 Hospital 1st floor Department of anaesthesiology Sri manakula vinayagar medical college and hospital Kalitheerthalkuppam Puducherry 605107
Pondicherry
PONDICHERRY
605107
India 
Phone  9676001102  
Fax    
Email  kirankumargp123@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ranjan R V 
Designation  Professor  
Affiliation  Sri Manakula vinayagar medical college and hospital 
Address  Room no 109 Hospital 1st floor Department of anaesthesiology Sri manakula vinayagar medical college and hospital Kalitheerthalkuppam Puducherry 605107
Room no 109 Hospital 1st floor Department of anaesthesiology Sri manakula vinayagar medical college and hospital Kalitheerthalkuppam Puducherry 605107
Pondicherry
PONDICHERRY
605107
India 
Phone  9600823772  
Fax    
Email  ranjanrv2005@gmail.com  
 
Details of Contact Person
Public Query
 
Name  G P Kirankumar  
Designation  Post graduate 
Affiliation  Sri Manakula vinayagar medical college and hospital 
Address  Room no 109 Hospital 1st floor Department of anaesthesiology Sri manakula vinayagar medical college and hospital Kalitheerthalkuppam Puducherry 605107
Room no 109 Hospital 1st floor Department of anaesthesiology Sri manakula vinayagar medical college and hospital Kalitheerthalkuppam Puducherry 605107

PONDICHERRY
605107
India 
Phone  9676001102  
Fax    
Email  kirankumargp123@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  G P kirankumar  
Address  Room no 109 Hospital 1st floor Department of anaesthesiology Sri manakula vinayagar medical college and hospital Kalitheerthalkuppam Puducherry 605107  
Type of Sponsor  Other [self] 
 
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 G P Kirankumar  Sri manakula vinayagar medical college  Room no 109 Hospital 1st floor Department of anaesthesiology Kalitheerthalkuppam Puducherry 605107
Pondicherry
PONDICHERRY 
9676001102

kirankumargp123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMVMCH   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K812||Acute cholecystitis with chronic cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparison of efficacy of posterior and subcostal techniques of ultrasound-guided transverse abdominis plane block in laparoscopic cholecystectomy  Posterior and subcostal transverse abdominis plane block will be compared using USG guidance in laparoscopic cholecystectomy  
Intervention  Comparison of efficacy of posterior and subcostal techniques of ultrasound-guided transverse abdominis plane block in laparoscopic cholecystectomy  Using ultrasound in laparoscopic cholecystectomy cases, sub costal and posterior TAP block will be performed in 10 minutes  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adult age group 18 to 60 years
ASA PS I and II
Either gender
Patient posted for elective Laparoscopic Cholecystectomy
 
 
ExclusionCriteria 
Details  Patients who refuse to give consent
Patients with coagulopathy renal dysfunction pregnancy
Patients with allergy to local anaesthetics
Patients with psychiatric illness substance abuse
History of opioid dependence
Laparoscopic converted to open cholecystectomy
Duration of surgery more than 3 hours
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of postoperative analgesia between posterior and subcostal approaches to ultrasound guided TAP block after laparoscopic cholecystectomy  Post operative analgesia using VAS score 1hr 2hr 4 hrs  
 
Secondary Outcome  
Outcome  TimePoints 
To compare the hemodynamic stability heart rate blood pressure SPO2 VAS between the two groups
To look for complications like LAST
 
intra operative 15 30 45 60 minutes  
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   27/08/2025 
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 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 has become the standard of care for gallbladder diseases due to its minimally invasive nature which results in reduced postoperative pain early recovery and decreased hospital stay compared to open surgery However despite its minimally invasive nature patients often experience moderate to severe postoperative pain particularly in the early hours after surgery Effective management of this pain is critical especially as laparoscopic cholecystectomy is commonly performed as an outpatient procedure necessitating rapid recovery and discharge In recent years there has been increasing interest in regional anesthesia techniques such as the transversus abdominis plane block as part of multimodal analgesia strategies TAP block involves the injection of local anesthetic between the internal oblique and transversus abdominis muscles to block afferent nerves of the anterior abdominal wall This technique provides a more localized analgesic effect and reduces the requirement for systemic opioids thus minimizing opioid-related side effects 

The TAP block was initially performed using a landmark based blind technique but advancements in ultrasound technology have improved the safety and accuracy of this procedure Two main ultrasound-guided techniques have emerged the posterior and subcostal techniques The posterior TAP block is administered near the triangle of Petit and predominantly provides analgesia T10 to L1 dermatomes making it more suitable for abdominal surgeries On the other hand the subcostal TAP block targets higher dermatomes T7 to T12 and is thus more effective for upper abdominal procedures Given the increasing reliance on outpatient surgery models and the need for effective opioid sparing analgesia evaluating the most effective TAP block approach for laparoscopic cholecystectomy remains an area of ongoing clinical interest This thesis aims to further investigate and compare the efficacy of these regional techniques in providing optimal postoperative analgesia for patients undergoing laparoscopic cholecystectomy
 
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