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CTRI Number  CTRI/2024/03/063802 [Registered on: 07/03/2024] Trial Registered Prospectively
Last Modified On: 20/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of MTAPA and OSTAP( two techniques of nerve blocks),to reduce pain, after laparoscopic gallbladder surgeries . 
Scientific Title of Study   Comparison of analgesic efficacy of ultrasound guided modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) VS oblique subcostal transversus abdominis plane block(OSTAP) in laproscopic cholecystectomy -A randomized 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  Rahul Katyal 
Designation  Post diploma DNB trainee  
Affiliation  Northern Railway Central Hospital 
Address  Department of anaesthesiology, Northern railway central hospital, Basant Lane, New delhi New Delhi

Central
DELHI
110055
India 
Phone  8360129948  
Fax    
Email  katyalrahul6@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sushil krishnan 
Designation  Assistant Chief Health Director 
Affiliation  Northern Railway Central Hospital 
Address  Department of anaesthesiology, Northern Railway Central Hospital, Basant Lane, New delhi

Central
DELHI
110055
India 
Phone  9717630552  
Fax    
Email  dr.sushilkrishnan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sushil krishnan 
Designation  Assistant chief health director 
Affiliation  Northern Railway Central Hospital, 
Address  Department of anaesthesiology, Northern Railway Central Hospital, Basant Lane, New Delhi

Central
DELHI
110055
India 
Phone  9717630552  
Fax    
Email  dr.sushilkrishnan@gmail.com  
 
Source of Monetary or Material Support  
Northern railway central hospital, basant lane, new delhi 
 
Primary Sponsor  
Name  Northern railway central hospital 
Address  Northern railway central hospital, basant lane, new delhi 
Type of Sponsor  Research institution and hospital 
 
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 Rahul katyal  Department of anaesthesiology, Northern Railway Central Hospital, Basant Lane, New Delhi  Northern railway central hospital, Basant lane New Delhi DELHI
Central
DELHI 
8360129948

katyalrahul6@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee, northern railway central hospital, IEC-NRCH  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  oblique subcostal [OSTAP] block  Ultrasound guided oblique subcostal [OSTAP] block using 0.5ml/kg of 0.2% Ropivacaine 
Intervention  ultrasound guided modified thoracoabdominal nerve block through perichondrial approach (M-TAPA)   ultrasound guided modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) using 0.5ml/kg of 0.2% Ropivacaine  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients aged 18 -75 years old, with American Society of Anaesthesiologists Physical Status grades [ASA] 1-3, scheduled for elective laparascopic cholecystectomy. 
 
ExclusionCriteria 
Details  Known allergy or intolerance to injection Ropivacaine.Infection at the injection site of the block.Opioid consumption in last 24 hours. Coagulopathy.Known case of Psychiatric illness.Body mass index (BMI) ≥ 40kg /m2. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the 24 hour cumulative post-operative analgesic consumption [Tramadol] between the M-TAPA block, and the OSTAP block after laparascopic cholecystectomy .  Comparison of total tramadol consumption in 24hours. 
 
Secondary Outcome  
Outcome  TimePoints 
NRS pain score  30min 1 hour 2 hour 4 hour 8hour 24 hour 
Time to first rescue analgesia  Time taken to give first rescue analgesia  
Comparison of QoR - 15 scale between the two groups  24 hours post operative 
Comparison of thoracoabdominal areas with sensory block(T3 -L1)
 
2 Hours following surgery 
 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   17/03/2024 
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 leads to somatic pain from the supraumbilical abdominal area and also visceral pain due to pneumoperitoneum and surgical manipulation.Pain managment in these patients is very important for enhanced recovery after surgery.Ultrasoundguidance and anatomic studies have led to the description of many new interfascial plane blocks.One of the most commonly used blocks is oblique transverse abdominisplane block[OSTAP] to relief post operative pain relief in laparoscopic abdominal surgeries.The thoracoabdominalnerves block through perichondrial approach[M-TAPA] is one of the newer blocks that is used nowadays for postoperative analgesia in laparoscopic abdominal surgeries. Early studies seem to indicate that M-TAPA  hasadvantage over OSTAP.

 

We will be conducting a double blinded, randomized control trial to compare the analgesic efficacy of ultrasound guided modified thoracoabdominal nerve block through perichondrial approach versus oblique subcostaltransversus abdominis plane block for laparoscopic cholecystectomy

 

Total of 60 patients will be randomly allocated into two equal groups of 30 patients each.The M-TAPA or OSTAP Blocks will be administered  following general anesthesia with endotracheal  intubation by the standard institutional  protocol. 

 

We will note the  24 hour  post-operative analgesic consumption [Tramadol ] ; the time of first rescue analgesic administration, and the NRS pain scale at 30 min ; 1 hour ; 2 hour ; 4 hour ; 8 hour and 24 hour will be noted .QoR-15 questionnaire scores both before and after the operation will recorded.Comparison of thoracoabdominal areas(T3-L1) with sensory block 2hours following surgery will be noted.

 
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