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CTRI Number  CTRI/2017/12/010969 [Registered on: 22/12/2017] Trial Registered Retrospectively
Last Modified On: 12/12/2019
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   TAP Block for post cesarean analgesia  
Scientific Title of Study   A Randomized double blinded study of ultrasound guided Transverse Abdominis Plane block for postoperative analgesia after cesarean section with Bupivacaine Vs Bupivacaine with dexamethasone (Perineural Vs intravenous) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ramya 
Designation  Post graduate student 
Affiliation  kanyakumari government medical college hospital  
Address  Department of anaesthesiology Kanyakumari government medical college hospital Asaripallam

Kanniyakumari
TAMIL NADU
629201
India 
Phone  7708200178  
Fax    
Email  ramyasatr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ramya and Dr Edward Johnson Joseph 
Designation  Post graduate student and Guide 
Affiliation  kanyakumari government medical college hospital  
Address  department of anaesthesiology kanyakumari government medical college hospital asaripallam

Kanniyakumari
TAMIL NADU
629201
India 
Phone  7708200178  
Fax    
Email  ramyasatr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ramya 
Designation  Post graduate student 
Affiliation  kanyakumari government medical college hospital  
Address  Department of anaesthesiology Kanyakumari government medical college hospital Asaripallam

Kanniyakumari
TAMIL NADU
629201
India 
Phone  7708200178  
Fax    
Email  ramyasatr@gmail.com  
 
Source of Monetary or Material Support  
Head of the department department of anaesthesiology kanyakumari government medical college hospital asaripallam 
 
Primary Sponsor  
Name  head of the department 
Address  department of anaesthesiology kanyakumari government medical college hospital asaripallam 
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 ramya  kanyakumari government medical college hospital  department of anaesthesiology kanyakumari government medical college hospital asaripallam
Kanniyakumari
TAMIL NADU 		 7708200178

ramyasatr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, kanyakumari government medical college hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O610||Failed medical induction of labor,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bupivacaine  Ultrasound Guided Transverse Abdominis plane block for Post Operative Analgesia after cesarean section with Bupivacaine 
Comparator Agent  Bupivacaine with dexamethasone  Ultrasound guided Transverse Abdominis Plane Block for Post operative analgesia after cesarean section with Bupivacaine and Dexamethasone 
Comparator Agent  Bupivacaine with Intravenous Dexamethasone  Ultrasound guided Transverse Abdominis Plane Block for Post operative analgesia after cesarean section with Bupivacaine and Intravenous Dexamethasone  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  ASA II
Posted for LSCS
 
 
ExclusionCriteria 
Details  Patient refusal
ASA grade III & IV
Height <140 cms,BMI>30
Known allergy to study drug
Patient with coagulopathies
Patient with diabetic renal liver diseases pre eclampsia eclampsia
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of analgesia   Time interval between the block time and the time of first analgesic dose 
 
Secondary Outcome  
Outcome  TimePoints 
complications  at the time of doing block 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/11/2016 
Date of Study Completion (India) 11/11/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   ABSTRACT
Background: This study is to compare the duration of analgesia with bupivacaine vs bupivacaine with dexamethasone (perineurally or intravenously) for post operative analgesia in patients undergoing caesarean section using ultrasound guided transerse abdominal block.

Patients and methods:60 ASA II antenatal patients coming for caesarean section randomized into three groups. Group B- 20ml of 0.25% bupivacaine with 2 ml of normal saline and 2ml distilled water. Group D1- 20 ml of 0.25% bupivacaine with 8mg dexamethasone and 2ml distilled water. Group D2 20 ml of 0.25% bupivacaine with 2 ml of normal saline and 8 mg dexamethasone. The following parameters were recorded. Block grade, Numerical pain scale for 24 hours postoperatively, duraion of analgesia, complications if any.

Results: 
 
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