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CTRI Number  CTRI/2024/05/067919 [Registered on: 27/05/2024] Trial Registered Prospectively
Last Modified On: 10/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive
Other (Specify) [Pain control , reducing opioid use]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study of Erector Spinae Plane block for postoperative analgesia in cesarean section 
Scientific Title of Study   A prospective randomised controlled study to determine the effect of bilateral ultrasound- guided Erector Spinae Plane block for postoperative analgesia in cesarean section  
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 Benita Abraham  
Designation  Junior Resident  
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Room 647 , Ladies hostel 5 , Sri Ramachandra Institute of Higher Education and Research, Porur , Chennai- 600116

Chennai
TAMIL NADU
600116
India 
Phone  8289915699  
Fax    
Email  BenitaA108@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajesh Kumar Kodali  
Designation  Associate Professor  
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Department of Anaesthesiology , Sri Ramachandra Institute of Higher Education and Research, Porur , Chennai- 600116

Chennai
TAMIL NADU
600116
India 
Phone  9962398266  
Fax    
Email  vrajesh.kodali@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajesh Kumar Kodali  
Designation  Associate Professor  
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Department of Anaesthesiology , Sri Ramachandra Institute of Higher Education and Research, Porur , Chennai- 600116

Chennai
TAMIL NADU
600116
India 
Phone  9962398266  
Fax    
Email  vrajesh.kodali@gmail.com  
 
Source of Monetary or Material Support  
Dr Benita Abraham , Department of Anaesthesiology , Sri Ramachandra institute of higher education and research , Porur , Chennai- 600116 , Tamil Nadu , India . 
 
Primary Sponsor  
Name  Dr Benita Abraham  
Address  Room 647 , Ladies Hostel 5 , Sri Ramachandra institute of higher education and research, Porur, Chennai - 600116.  
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 Benita Abraham   Sri Ramachandra institute of higher education and research   6th floor , A block , Department of Anaesthesiology , Sri Ramachandra institute of higher education and research , Porur , Chennai -600116 TAMIL NADU
Chennai
TAMIL NADU 		 8289915699

BenitaA108@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee (for Medical PG Students), SRIHER (DU)   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
Modification(s)  
Type  Name  Details 
Intervention  Erector Spinae Plane Block  Erector spinae plane (ESP) block is a para-spinal regional anesthesia technique that allows local anesthetic dispersion into the interfascial plane between the transverse process and the erector spinae muscles, attaining a paravertebral spread of three and four vertebral levels cranially and caudally, respectively covering the ventral as well as dorsal rami inhibiting both visceral as well as somatic pain. It will be given as single-shot post cesarean section and may act for up to 8-12 hours for the intervention group . 20 ml of 0.25% bupivacaine will be given in the intervention group . 
Comparator Agent  Tramadol  Standard analgesia is provided with IV Tramadol 50mg BD 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  Undergoing Cesarean Section  
 
ExclusionCriteria 
Details  Patient refusal to ESPB
presence of coagulopathy or bleeding disorder
were administered an antiplatelet agent
local infection at the injection site
hypersensitivity to local amide anesthetics
central neuropathy
uncontrolled diabetes mellitus
significant cardiopulmonary disease, hepatic or renal failure or psychiatric disease.
Inability to give consent to the study
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Other 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Visual analog scale (VAS) for pain   0 hour, 2 hours , 4hours, 6 hours , 8 hours, 12hours 24 hours and 48 hours
 
 
Secondary Outcome  
Outcome  TimePoints 
Total postoperative analgesia
 		 24 hours  
Time for the first request to analgesia  Hours 
Incidence of adverse effects  Number of events in 48 hours  
 
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   Phase 3 
Date of First Enrollment (India)   07/06/2024 
Date of Study Completion (India) 07/07/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 07/07/2024 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Published journals

  6. For how long will this data be available start date provided 01-09-2024 and end date provided 12-05-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   We are conducting a study in patients who are undergoing cesarean section to compare Erector spinae block against standard analgesia . Erector Spinae Plane block is used to reduce pain after surgery. We will collect data from participants after the procedure to compare both regimes and see which is providing more effective analgesia and is better tolerated . This data will help us in future to choose and provide good anesthesia for other patients. It’s is a PROSPECTIVE RANDOMIZED CONTROLLED , SINGLE BLIND STUDY.  
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