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CTRI Number  CTRI/2024/03/064113 [Registered on: 14/03/2024] Trial Registered Prospectively
Last Modified On: 13/03/2024
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   Comparison of two pain relief methods for caesarean section: ultrasound-guided erector spinae plane block and transversus abdominis plane block, both used with spinal anesthesia. 
Scientific Title of Study   Comparative evaluation of ultrasound guided erector spinae plane block and transversus abdominis plane block for post operative analgesia in lower segment caesarean section under subarachnoid block 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nishtha Narang 
Designation  Post Graduate Student 
Affiliation  Maulana Azad Medical College 
Address  Room number 302 3rd floor BL Taneja Block Department of Anaesthesiology Maulana Azad Medical College Central Delhi
Room number 302 3rd floor BL Taneja Block Department of Anaesthesiology Maulana Azad Medical College Central Delhi
Central
DELHI
110002
India 
Phone  09871069874  
Fax    
Email  narangnishtha5@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sonia Wadhawan 
Designation  Director Professor 
Affiliation  Maulana Azad Medical College 
Address  Room Number 302 3rd Floor Bl Taneja Block Department Of Anaesthesiology Maulana Azad Medical College Central Delhi

Central
DELHI
110002
India 
Phone  9968604218  
Fax    
Email  soniawadhawan@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nishtha Narang 
Designation  Post Graduate Student  
Affiliation  Maulana Azad Medical College 
Address  Room Number 302 3rd Floor Bl Taneja Block Department Of Anaesthesiology Maulana Azad Medical College Central Delhi

Central
DELHI
110002
India 
Phone  9871069874  
Fax    
Email  narangnishtha5@gmail.com  
 
Source of Monetary or Material Support  
Lok Nayak Hospital, Jawaharlal Nehru Marg, Near Delhi Gate, New Delhi - 110002 
 
Primary Sponsor  
Name  Maulana Azad Medical College 
Address  Maulana Azad Medical College, 2, Bahadur Shah Zafar Marg, New Delhi - 110002 
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 Nishtha Narang  Lok Nayak Hospital  Gynae OT, 1st floor, Gynae block Department of Anaesthesiology Central Delhi
Central
DELHI 		 9871069874

narangnishtha5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Maulana Azad Medical College   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, (2) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ultrasound guided erector spinae plane block  ultrasound guided erector spinae plane block with 20ml of 0.25% bupivacaine bilaterally in immediate postoperative period for postoperative analgesia in LSCS under subarachnoid block 
Comparator Agent  ultrasound guided transversus abdominis plane block  ultrasound guided trnsversus abdominis plane block with 20ml of 0.25% bupivacaine bilaterally in immediate postoperative period for post operative analgesia in LSCS under subarachnoid block 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Patients belonging to ASA Grade II/III

Patients height between 150 to 170 cm 
 
ExclusionCriteria 
Details  Obstetric complications like antepartum hemorrhage (APH), severe preeclampsia, severe heart disease.

Any allergy to study medication 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Time to rescue analgesia  24 hours in post operative period 
 
Secondary Outcome  
Outcome  TimePoints 
1. Post operative NRS score till 24 hours
2. Total amount of rescue analgesic consumption up to 24 hours postoperatively.
3. Post block hemodynamic parameters monitored and recorded till 24hours
4. Block related complications 		 24 hours in post operative period 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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 2 
Date of First Enrollment (India)   21/03/2024 
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="1"
Months="0"
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   We are comparing the efficacy of ultrasound guided erector spinae plane block and transversus abdominis plane block for postoperative analgesia using bupivacaine in patients of reproductive age group undergoing caesarean section. The aim of the study is to compare the efficacy of ultrasound guided ESP and TAP block, taking a total sample size of 42, 21 patients in each group. 
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