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CTRI Number  CTRI/2024/05/067456 [Registered on: 15/05/2024] Trial Registered Prospectively
Last Modified On: 14/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing three techniques for reducing pain after caesarean section surgery  
Scientific Title of Study   Comparison of Transversus Abdominis Plane block, Quadratus Lumborum block and Thoracic Erector Spinae plane block for post-operative analgesia after caesarean section using dexmedotomidine as adjuvant to Ropivacaine- A Randomised Clinical Trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanket Agrawal  
Designation  Assistant Professor  
Affiliation  Autonomous State Medical College, Shahjahanpur  
Address  Department of Anaesthesiology, Autonomous State Medical College, Shahjahanpur

Shahjahanpur
UTTAR PRADESH
242001
India 
Phone  8830991364  
Fax    
Email  sanketagrawal2391@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanket Agrawal  
Designation  Assistant Professor  
Affiliation  Autonomous State Medical College, Shahjahanpur  
Address  Department of Anaesthesiology, Autonomous State Medical College, Shahjahanpur

Shahjahanpur
UTTAR PRADESH
242001
India 
Phone  8830991364  
Fax    
Email  sanketagrawal2391@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanket Agrawal  
Designation  Assistant Professor  
Affiliation  Autonomous State Medical College, Shahjahanpur  
Address  Department of Anaesthesiology, Autonomous State Medical College, Shahjahanpur

Shahjahanpur
UTTAR PRADESH
242001
India 
Phone  8830991364  
Fax    
Email  sanketagrawal2391@gmail.com  
 
Source of Monetary or Material Support  
Autonomous State Medical College Shahjahanpur district Shahjahanpur, Uttar Pradesh, India- 242001 
 
Primary Sponsor  
Name  Dr Sanket Agrawal 
Address  Department of Anesthesiology, Autonomous State Medical College Shahjahanpur district Shahjahanpur, Uttar Pradesh, India- 242001 
Type of Sponsor  Other [Self] 
 
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 Sanket Agrawal  Autonomous State Medical College Shahjahanpur   Obstetric and gynaecology operation theatre, OT Number 3, first floor
Shahjahanpur
UTTAR PRADESH 		 8830991364

sanketagrawal2391@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ASMC Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 1||Obstetrics, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Quadratus Lumborum block, Transversus Abdominis Plane block, Thoracic Erector Spinae plane block  Comparing post operative analgesia after caesarean section using Inj Ropivacaine 0.2% (0.5ml/kg body weight)+ Inj Dexmedotomidine (1microgm per kg body weight) single shot injected locally in respective muscle plane and measured upto 24hours postoperatively 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  1.Undergoing Elective caesarian section under spinal anesthesia
2.ASA grade I and II
3.Singleton pregnancy with gestation age more than 37 weeks 
 
ExclusionCriteria 
Details  1.Refuse to participate
2.Inability to comprehend or participate in the pain scoring system
3.Patients with systemic coagulopathy, anatomic abnormalities or are allergic to the drugs used in study or have a localised infection not fit for the local drug administration.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the duration of analgesia (first request to rescue analgesia)  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To compare pain scores [numerical rating score (NRS)], total amount of diclofenac consumption, incidence of nausea-vomiting, parturient satisfaction and other adverse effects in 24 hours postoperatively.  6 months 
 
Target Sample Size   Total Sample Size="63"
Sample Size from India="63" 
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 4 
Date of First Enrollment (India)   01/06/2024 
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="0"
Months="6"
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   Comparison of Transversus Abdominis Plane block, Quadratus Lumborum block and Thoracic Erector Spinae plane block for post-operative analgesia after caesarean section using dexmedotomidine as adjuvant to Ropivacaine- A Randomised Clinical Trial



I wish to compare above three anaesthetic block techniques to know which one will help in better post operative analgesia . Earlier studies havent compared all three techniques together and also havent used both the drugs ropivacaine and dexmedotomidine together.
 
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