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CTRI Number  CTRI/2025/07/091732 [Registered on: 25/07/2025] Trial Registered Prospectively
Last Modified On: 24/07/2025
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   A study comparing two types of nerve blocks given before surgery to reduce pain after gallbladder removal under general anaesthesia. 
Scientific Title of Study   Preemptive Ultrasound guided Modified Thoracoabdominal nerve block via perichondrial approach (M - TAPA) vs oblique subcostal transversus abdominis plane block for postoperative analgesia in patients undergoing laparoscopic cholecystectomy under general anaesthesia - A 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 Deepak Vijaykumar Kadlimatti 
Designation  Associate Professor 
Affiliation  Dr B R Ambedkar medical college and hospital 
Address  Department of Anaesthesiology Dr B R Ambedkar medical college and hospital Shampura main road Kadugondanahalli Bangalore

Bangalore
KARNATAKA
560045
India 
Phone  9008229914  
Fax    
Email  deepakkadlimatti@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepak Vijaykumar Kadlimatti 
Designation  Associate Professor 
Affiliation  Dr B R Ambedkar medical college and hospital 
Address  Department of Anaesthesiology Dr B R Ambedkar medical college and hospital Shampura main road Kadugondanahalli Bangalore

Bangalore
KARNATAKA
560045
India 
Phone  9008229914  
Fax    
Email  deepakkadlimatti@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Deepak Vijaykumar Kadlimatti 
Designation  Associate Professor 
Affiliation  Dr B R Ambedkar medical college and hospital 
Address  Department of Anaesthesiology Dr B R Ambedkar medical college and hospital Shampura main road Kadugondanahalli Bangalore

Bangalore
KARNATAKA
560045
India 
Phone  9008229914  
Fax    
Email  deepakkadlimatti@gmail.com  
 
Source of Monetary or Material Support  
Dr B R Ambedkar medical college and hospital. Shampura main road. Kadugondanahalli. Bangalore 560045 
 
Primary Sponsor  
Name  Dr B R Ambedkar medical college and hospital 
Address  Ot complex, Dr B R Ambedkar medical college and hospital, Shampura main road, Kadigondanahalli, Bangalore 560045 
Type of Sponsor  Private 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 Deepak Vijaykumar Kadlimatti  Dr B R Ambedkar medical college and hospital  Ot complex, Department of anaesthesiology, Dr B R Ambedkar medical college and hospital, Shampura main road, Kadigondanahalli, Bangalore 560045
Bangalore
KARNATAKA 
9008229914

deepakkadlimatti@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, Dr B R Ambedkar medical college and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bilateral Modified Thoracoabdominal nerve block through perichondrial approach for postoperative analgesia in patients undergoing laparoscopic cholecystectomy under general anaesthesia   Group A will receive ultrasound guided Modified Thoracoabdominal nerve block through perichondrial approach at 10th costal costochondral junction with Inj Bupivacaine (0.25%) 20ml with Inj Dexamethasone 4mg 
Comparator Agent  Bilateral Oblique Subcostal Transversus abdominis plane block for postoperative analgesia in patients undergoing laparoscopic cholecystectomy under general anaesthesia  Group B will receive ultrasound guided Oblique Subcostal Transversus abdominis plane block to transversus abdominis fascia with Inj Bupivacaine (0.25%) 20ml with Inj Dexamethasone 4mg 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients posted for elective laparoscopic cholecystectomy under general anaesthesia.2. Patients aged between 18 to 75y.3. Patients belonging to American Society of Anaesthesiologists physical status (ASA - PS) 1 and 2  
 
ExclusionCriteria 
Details  1. Known allergy to the local anaesthetics given.
2. Patients with chronic pain on slow-release preparations of opioid, drug or alcohol abuse.
3. Patients with dementia or cognitive problems.
4. Patients with BMI more than 35 kg/m2.
5. Coagulopathy or patients on anti-coagulants
6. Patients who are known case of diabetes mellitus. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the duration of postoperative analgesia following laparoscopic cholecystectomy in both groups  The time period from administration of block till first rescue analgesia for first 24 postoperative hours  
 
Secondary Outcome  
Outcome  TimePoints 
To compare total analgesic consumption during postoperative period over 24 hours in both groups.
To assess the adverse effects associated with analgesics such as nausea, vomiting.  
Time of administration of block to 24 postoperative hours 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   04/08/2025 
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="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 - NO
Brief Summary  

Laparoscopic cholecystectomy (LC) is a frequently performed surgery as the gold standard in the treatment of symptomatic gallstone disease. Despite the introduction of a  minimally invasive approach, cholecystectomy can cause significant postoperative pain owing to multifactorial factors.  Acute postoperative pain is the most common cause of patient discomfort during the period after LC and is the most common cause of readmission after discharge. Poorly controlled postoperative pain impairs the quality of recovery, increasing the risk of postoperative pulmonary complications as risk factor for the formation of chronic pain. It was observed that the abdominal pain following LC mostly originates from the incision area, and the remaining part consists of visceral and referred pain. Multimodal analgesia, including opioids is used to limit pain following LC. Treatment with opioids might cause side effects for example postoperative nausea and vomiting, constipation, respiratory depressionOblique subcostal transverse abdominis plane block (OSTAP) provides a wide range of analgesia from T7 – T12, is effective for 6 – 18h postoperatively, however it requires multiple injections to achieve complete analgesiaModified thoracoabdominal nerve block through perichondrial approach (M – TAPA)  is a newer technique which has received increasing attention due to its wide range of analgesic coverage of the trunk (that is T5 – T12)  with a single puncture per side and has been  reported to provide a long acting effect. M – TAPA offers blocking both anterior and lateral cutaneous branches of the thoracoabdominal nerves, surpassing the limitations of conventional techniques such as transversus abdominis plane blockWe hypothesize that M – TAPA block would be more effective than OSTAP block for controlling postoperative pain, considering its range of efficacy and long term durability.

 
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