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CTRI Number  CTRI/2019/03/018103 [Registered on: 15/03/2019] Trial Registered Prospectively
Last Modified On: 14/03/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   This study is being conducted to compare two methods of pain relief for cesarean section one of which involves giving an injection in the back and the other over sides of abdomen 
Scientific Title of Study   Comparative study between Erector spinae plane block and Transversus abdominis plane block for postoperative analgesia in lower segment caesarean deliveries - A randomised control study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SUSHMA TK 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Anaesthesiology Kasturba Medical College Manipal
Kasturba Medical College
Udupi
KARNATAKA
576104
India 
Phone  9701720077  
Fax    
Email  drsushmagowda@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  SUSHMA TK 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Anaesthesiology Kasturba Medical College Manipal
Kasturba Medical College
Udupi
KARNATAKA
576104
India 
Phone  9701720077  
Fax    
Email  drsushmagowda@gmail.com  
 
Details of Contact Person
Public Query
 
Name  SUSHMA TK 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Anaesthesiology Kasturba Medical College Manipal
Kasturba Medical College
Udupi
KARNATAKA
576104
India 
Phone  9701720077  
Fax    
Email  drsushmagowda@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College student research fund, Kasturba Medical College, MAHE, Manipal 576104, Udupi 
 
Primary Sponsor  
Name  Kasturba Medical College student research fund 
Address  Kasturba Medical College Manipal 
Type of Sponsor  Private 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 
Nimmala Vinod Reddy  Kasturba Medical College and Hospital  Department of Anaesthesiology
Udupi
KARNATAKA 
9701720077

vinodreddy.nimmala@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Erector Spinae Plane block  Ultrasound guided bilateral Erector Spinae Plane block given with 20 ml of 0.2% Ropivacaine with 25mcg Dexmedetomidine on either side 
Comparator Agent  Transversus Abdominis Plane block  Ultrasound guided bilateral Transversus Abdominis Plane block with 20 ml of 0.2% Ropivacaine with 25 mcg Dexmedetomidine on either side 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  All ASA II pregnant women in the age group of 18 to 40 years undergoing elective lower segment caesarean deliveries under subarachnoid block are included in the study  
 
ExclusionCriteria 
Details  Patient refusal
Coagulation disorders
Local infection at the site of block
Allergy to study medications
BMI >35 kg/m2
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
a) Duration of analgesia (by noting down the demand for first analgesia)
b) 24 hour opioid (tramadol) consumption
 
Every hour for the first 10 hours and 24 hrs postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
Patient satisfaction score from 1 to 10  24hours after the surgery 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/04/2019 
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="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Caesarean delivery is one of the most commonly performed surgical procedures. The postoperative pain associated with it causes significant reduction in the functional quality of the postpartum mother especially on the day of the procedure. The optimum form of postoperative analgesia is not known, but many procedures are carried out under spinal anaesthesia and patients typically receive spinal opioids, systemic opioids as components of multimodal analgesia in the postoperative period. However, long acting opioids, whether given via the spinal or systemic route, are frequently associated with adverse effects such as nausea, pruritus, sedation and occasionally respiratory depression. Thus knowledge about the alternative (non-opioid) analgesia especially regional techniques is important.

The regional techniques like epidural and TAP blocks have been found to provide effective postoperative analgesia in cesarean deliveries. ESP block is a novel technique which has found its applicability in many truncal and hip surgeries. Also, it is believed that this technique is technically less demanding as compared to other techniques described above

 
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