FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/095473 [Registered on: 30/09/2025] Trial Registered Prospectively
Last Modified On: 05/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Process of Care Changes 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To determine the quality of recovery and pain in patients undergoing casarean section under spinal anaesthesia. 
Scientific Title of Study   To determine the quality of recovery and VAS score in patients undergoing caesarean section under spinal anaesthesia with TAP block as compared to spinal anaesthesia with local wound inflitration. 
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 Poornima Birajdar 
Designation  Senior resident 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Anaesthesiology,first floor,main OT complex,Kasturba Medical College Manipal,Udupi
Department of Anaesthesiology,first floor,main OT complex,Kasturba Medical College Manipal,Udupi
Udupi
KARNATAKA
576104
India 
Phone  09008307099  
Fax    
Email  poornima.birajdar@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Poornima Birajdar 
Designation  Senior resident 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Anaesthesiology,first floor,Main OT complex,Kasturba Medical College Manipal,Udupi
Department of Anaesthesiology,first floor,Main OT complex,Kasturba Medical College Manipal,Udupi
Udupi
KARNATAKA
576104
India 
Phone  09008307099  
Fax    
Email  poornima.birajdar@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Sushma H 
Designation  Senior resident 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Anaesthesiology,first floor,Main OT complex,Kasturba Medical College Manipal,Udupi
Department of Anaesthesiology,first floor,Main OT complex,Kasturba Medical College Manipal,Udupi
Udupi
KARNATAKA
576104
India 
Phone  9483305224  
Fax    
Email  h.sushma@manipal.edu  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Kasturba Medical College 
Address  Kasturba medical college, Manipal , 576104 
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 
Dr Anula Dsouza  Kasturba Medical College Manipal  Department of Anaesthesiology,first floor,Main OT complex.
Udupi
KARNATAKA 		 9686425707

dsouza.anula@manipal.edu 
 
Details of Ethics Committee
Modification(s)  
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: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Spinal Anaesthesia with Local Wound inflitration.  Obstetric Quality Recovery Score and Pain Score(VAS Score)will be assesed in patients undergoing caesarean section under spinal anaesthesia with Local Wound Inflitration at 6,12,24 hrs. 
Intervention  Spinal Anaesthesia with TAP block.  Obstetric Quality Recovery Score and Pain Score(VAS Score)will be assesed in patients undergoing caesarean section under spinal anaesthesia with TAP block at 6,12,24 hrs. 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  Participant age more than 18years
Participants posted for caesarean section under spinal anaesthesia
ASA Physical Status 2
 
 
ExclusionCriteria 
Details  Refusal for spinal anaesthesia
ASA Physical Status 3 and above
Participants undergoing Cesarean section under General anaesthesia
Category 1 Cesarean section.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Recovery of the patients post caesarean section is assessed using obstetric quality of recovery 10 score along with VAS score is noted.

early ambulation between the two groups
 		 6 hours
12 hours
24 hours post surgery
 
 
Secondary Outcome  
Outcome  TimePoints 
the time for need for the first rescue analgesia.
 		 6 hours
12 hours
24 hours post surgery 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   15/10/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Patient’s recovery after Cesarean section is dependent on various factors like patient factor, surgical intervention, anaesthetic exposure and post operative complications. 

Most of the recovery scores in the post operative period mainly focuses on mortality and morbidity but obstetric quality recovery 10 score is a scoring tool which accurately evaluates postoperative recovery by measuring domains, including: pain, physical comfort, physical independence, psychological support, and emotional state while the VAS score gives is limited only to pain. 

The paucity in literature where the above-mentioned domains are not considered for assessment of recovery of obstetric patients and the lack of literature about the mode of anaesthesia that would affect the recovery of patients has led us to do this study which clears these lacunae by considering these domains mentioned in the obstetric quality recovery 10 score patients undergoing Cesarean section under spinal anaesthesia.

 
Close