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CTRI Number  CTRI/2021/05/033512 [Registered on: 10/05/2021] Trial Registered Prospectively
Last Modified On: 08/05/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparative study of two methods of nerve block (during surgery and the other after surgery) for pain on pain relief after cesarean section 
Scientific Title of Study   Analgesic effectiveness of surgically administered transversus abdominis plane block versus conventional transversus abdominis plane block in elective caesarean sections – an open labelled randomised control trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jahnavi Jayakumar J 
Designation  Postgraduate 
Affiliation  Bangalore Baptist Hospital 
Address  Room number 137, department of OBG, Bangalore Baptist Hospital, Bellary Rd, Vinayakanagar, Hebbal, Bengaluru, Karnataka
Room number 137, department of OBG, Bangalore Baptist Hospital, Bellary Rd, Vinayakanagar, Hebbal, Bengaluru, Karnataka
Bangalore
KARNATAKA
560024
India 
Phone  08861138840  
Fax    
Email  jahnavijay@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shiny Varghese 
Designation  Head of the Department 
Affiliation  Bangalore Baptist Hospital 
Address  Room number 137, department of OBG, Bangalore Baptist Hospital, Bellary Rd, Vinayakanagar, Hebbal, Bengaluru, Karnataka
Room number 137, department of OBG, Bangalore Baptist Hospital, Bellary Rd, Vinayakanagar, Hebbal, Bengaluru, Karnataka
Bangalore
KARNATAKA
560024
India 
Phone  9880632522  
Fax    
Email  shinyashishvarghese@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shiny Varghese 
Designation  Head of the department 
Affiliation  Bangalore Baptist Hospital 
Address  Room number 137, department of OBG, Bangalore Baptist Hospital, Bellary Rd, Vinayakanagar, Hebbal, Bengaluru, Karnataka
Room number 137, department of OBG, Bangalore Baptist Hospital, Bellary Rd, Vinayakanagar, Hebbal, Bengaluru, Karnataka
Bangalore
KARNATAKA
560024
India 
Phone  9880632522  
Fax    
Email  shinyashishvargheses@gmail.com  
 
Source of Monetary or Material Support  
Bangalore Baptist Hospital 
 
Primary Sponsor  
Name  Bangalore Baptist Hospital 
Address  Bellary Rd, Vinayakanagar, Hebbal, Bengaluru, Karnataka 
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 Jahnavi Jayakumar  Bangalore Baptist hospital  OPD no 137, Department of OBG, Bangalore Baptist Hospital bellary road Hebbal
Bangalore
KARNATAKA 
8861138840

jahnavijay@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review board, Bangalore Baptist Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional TAP block with 0.25% Bupivacaine 25 ml each side  Patients in Group B will receive conventional TAP block with 0.25% Bupivacaine 25 ml each side. The conventional TAP will be performed by the anesthesiologist, under ultrasound-guidance, after the completion of surgery.  
Intervention  Surgically administered TAP block with 0.25% Bupivacaine 25 ml each side  In participants allocated to Group A after the completion of uterine closure and confirmation of haemostasis, surgical TAP block will be administered by operating surgeon using a technique adapted from the description by Owen et.al. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Pregnant women undergoing elective caesarean section under spinal anaesthesia
2. Age group of 18-40 years.
3. ASA grade I or II.
 
 
ExclusionCriteria 
Details  1. Patient refusal
2. If vertical abdominal incision was required
3. Planned duration of surgery more than two hours
4. Having blood loss greater than 2 L
5. Thrombocytopenia
6. Coagulopathy or anti-coagulation treatment (INR>1.5)
7. History of allergy to the study drug
8. Body Mass Index (BMI) <18 or >35 Kg/m2
9. Patients with hypertensive disorders
10. Alcohol or drug abuse.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Time to rescue analgesia  Before 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
• Time taken to perform the TAP block  AT THE TIME OF PROCEDURE 
Amount of rescue analgesia  Before 24 hours 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   14/05/2021 
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   not done 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Caesarean section delivery is becoming more frequent and at present is one of the most common major operative procedures performed worldwide. It is important that effective postoperative analgesia is provided to facilitate early ambulation, infant care (which also includes breast feeding, mother infant bonding) and prevention of postoperative morbidity. Therefore, the analgesic regimen needs to meet the goals of providing safe and effective analgesia with minimal side effects for the mother and the neonate. TAP block as a part of multimodal analgesic regimen would result in decreased opioid and NSAID consumption and improved analgesia. TAP block is conventionally performed by the anaesthesiologist, using a percutaneous approach under ultrasound-guidance. The surgically administered TAP block is a variant of TAP block administration, the efficacy of which in comparison to the conventional TAP block as a part of multimodal analgesic regimen following caesarean section is not very widely studied till date. Our study is designed to assess if the newly described surgical TAP block is as effective as the conventional TAP block (by comparing the requirement of rescue analgesia in both the groups) for post-operative analgesia following caesarean section in the Indian set-up in which surgical TAP block prove to be an easier procedure as there no the need for skilled operators or specialized equipment.

 
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