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CTRI Number  CTRI/2021/02/030926 [Registered on: 02/02/2021] Trial Registered Prospectively
Last Modified On: 15/01/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Transversalis Fascia Plane Block (TFP) versus Transverse Abdominis Plane (TAP) block for pain relief after Caesarean section delivery 
Scientific Title of Study   Comparison of Transversalis Fascia Plane Block versus Transverse Abdominis Plane block for postoperative analgesia in patients undergoing caesarean section: A Randomized controlled trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rajnish Kumar 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences Patna 
Address  All India Institute of Medical Sciences Patna Department of Anaesthesiology Room no 3 B5A, IPD building Phulwarisharif Patna

Patna
BIHAR
801507
India 
Phone  7783865337  
Fax    
Email  drraj76pmch@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Rajnish Kumar 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences Patna 
Address  All India Institute of Medical Sciences Patna Department of Anaesthesiology Room no 3 B5A, IPD building Phulwarisharif Patna

Patna
BIHAR
801507
India 
Phone  7783865337  
Fax    
Email  drraj76pmch@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rajnish Kumar 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences Patna 
Address  All India Institute of Medical sciences Patna Department of Anaesthesiology Room no 3 B5A, IPD building Phulwarisharif AIIMS Patna

Patna
BIHAR
801507
India 
Phone  7783865337  
Fax    
Email  drraj76pmch@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Patna 
 
Primary Sponsor  
Name  All India institute of Medical Sciences Patna 
Address  All India institute of Medical Sciences Patna Department of Anaesthesiology Patna Bihar  
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 
Rajnish Kumar  All India Institute of Medical sciences, Patna  All India Institute of medical sciences, Patna Department of Anaesthesia, Room no 3 B5A, IPD building
Patna
BIHAR 		 7783865337

drraj76pmch@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute Of Medical Sciences, Patna Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures, (2) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Transversalis Fascia Plane Block  Transversalis Fascia Plane Block with 0.25% 15ml levobupivacaine for postoperative analgesia in patients undergoing caesarean section 
Comparator Agent  Transverse abdomins Plane Block  Transverse abdomins Plane Block with 0.25% 15ml levobupivacaine for postoperative analgesia in patients undergoing caesarean section 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. ASA I and II
2. Patients between the ages of 18-45 years
 
 
ExclusionCriteria 
Details  1. Patient refusal
2. Coagulopathy /thrombocytopenia
3. Localised infection at the proposed site of injection.
4. Inability to comprehend the scoring systems to be employed due to physical or mental problems
5. Known allergy to the drugs to be used (local anaesthetics, opioids)
6. Opioid tolerance /dependence
7. Renal/hepatic impairment
8. Known cardio respiratory impairment
9. Patient with any neurological disorder.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess time to first rescue analgesia after block  time to first rescue analgesia after block 
 
Secondary Outcome  
Outcome  TimePoints 
• Compare pain using the Numerical Rating Score (NRS) at 0, 30 min, 1 hr, 6 hr, 12 hr and 24 hrs post-surgery.
• To compare the total opioid consumption in 24 hours.
 		 24hrs 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   17/02/2021 
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)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Caesarian section is one of the most commonly done lower abdominal surgeries. Regional Anaesthesia is a part of multimodal analgesia which can be used for lower abdominal surgeries. Transversalis abdominis plane block reduces opioid consumption and patient satisfaction and improves postoperative pain management. Transversalis Fascia plane block is given in the posterior axillary line, which blocks the branches of L1 nerve roots and ilioinguinal and iliohypogastric nerves. Fewer Study  compared Transversalis Fascia plane block  versus transverse abdominis plane block in cesarean section for postoperative analgesia. 
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