FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/01/022813 [Registered on: 16/01/2020] Trial Registered Prospectively
Last Modified On: 21/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Compare the pain releif benefit of Ultrasound guided abdominal plane nerve block and standard pain releief technique in patients following cesarean delivery and its relation with OXTR gene 
Scientific Title of Study   A randomized controlled study comparing the ultrasound-guided Transversalis fascia plane block and standard multimodal analgesia technique utilizing wound infiltration for post-caesarean pain management and mRNA expression of OXTR gene  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Diksha Gaur 
Designation  Post-graduate student 
Affiliation  University College Of Medical Sciences and GTB Hospital 
Address  Department of Anesthesiology, Critical Care and Pain Medicine, University College Of Medical Sciences and GTB Hospital, Dilshad Garden, New Delhi-110095

East
DELHI
110034
India 
Phone  09818392246  
Fax    
Email  diksha.gaur@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  GEETANJALI T CHILKOTI 
Designation  Professor 
Affiliation  University College Of Medical Sciences and GTB Hospital 
Address  Department of Anesthesiology, Critical Care and Pain Medicine, University College Of Medical Sciences and GTB Hospital, Dilshad Garden, New Delhi-110095

East
DELHI
110095
India 
Phone  09818392246  
Fax    
Email  geetanjalidr@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Diksha Gaur 
Designation  Post-graduate student 
Affiliation  University College Of Medical Sciences and GTB Hospital 
Address  Department of Anesthesiology, Critical Care and Pain Medicine, University College Of Medical Sciences and GTB Hospital, Dilshad Garden, New Delhi-110095


DELHI
110034
India 
Phone  09818392246  
Fax    
Email  diksha.gaur@gmail.com  
 
Source of Monetary or Material Support  
Intramural Grant, University College Of Medical Sciences and GTB Hospital, Delhi-110095 
 
Primary Sponsor  
Name  University College Of Medical Sciences 
Address  Department of Anaesthesiology,Critical Care and Pain Medicine, Second Floor, University College Of Medical Sciences and GTB Hospital, Dilshad Garden, Delhi-110095 
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 
Diksha Gaur  University College Of Medical Sciences and GTB Hospital  Department of Anaesthesiology, Critical Care and Pain Medicine, Second Floor, University College of Medical Sciences (University of Delhi) and GTB Hospital, Delhi-110095
East
DELHI 		 09818392246

diksha.gaur@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Ethics Committe-Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Patients will receive bilateral Ultrasound-guided Transversalis fascia plane block at the end of the surgery   Patients will receive bilateral Ultrasound-guided Transversalis fascia plane block at the end of the surgery for post-operative pain management 
Comparator Agent  Patients will receive standard multimodal pain management at the end of the surgery  Patients will receive standard multimodal pain management at the end of the surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Patients of ASA grade I or II undergoing lower segment caesarean section with pfannenstiel incision under subarachnoid block 
 
ExclusionCriteria 
Details  Patients having other causes of chronic pain,Patients having cognitive dysfunction or inability to comprehend various questionnaires, Patients having chronic neurological disorders/substance abuse,body mass index (BMI) > 40 kg/m2  
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine and compare the time to first request of analgesia between the two groups  The Time to first request of analgesia will be measured from completion of the intervention i.e. wound infiltration or abdominal plane block following the completion of surgery till the patients first demand for analgesia  
 
Secondary Outcome  
Outcome  TimePoints 
NRS pain score at rest and movement,
Total consumption of diclofenac in 24 hours, Pain detect questionnaire (PDQ), NPSI scores, SF-12 score,
Incidence of CPSP 		 Incidence of CPSP at the end of 14th week and rest all parameters at the end of 1st, 6th and 12th, 24th hour and then at the end of 6th week, 10th week, and 14th week. 
 
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 4 
Date of First Enrollment (India)   20/01/2020 
Date of Study Completion (India) 31/07/2021 
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)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Chilkoti GT, Gaur D, Saxena AK, Gupta A, Agarwal R, Jain S. Ultrasound-guided transversalis fascia plane block versus wound infiltration for both acute and chronic post-caesarean pain management - A randomised controlled trial. Indian J Anaesth. 2022 Jul;66(7):517-522. doi: 10.4103/ija.ija_173_22. Epub 2022 Jul 22. PMID: 36111099; PMCID: PMC9468997. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
The present randomized controlled study aims to compare the ultrasound-guided Transversalis fascia plane block and standard multimodal analgesia technique utilizing wound infiltration for post-caesarean pain management and comparison of mRNA expression of OXTR gene between the two groups. Standard anaesthetic technique for subarachnoid block will be adopted in all patients undergoing caesarean section. Patients will be randomized into two groups. A total of 60 patients with 30 patients in each group will be recruited, in Group C, patients will receive standard multimodal analgesia including wound infiltration (20 ml of 0.375% ropivacaine) at the end of the surgery and patients in group-T, will receive bilateral Ultrasound-guided Transversalis fascia plane block (20 ml of 0.375% ropivacaine) at the end of the surgery. In both the groups, exogenous oxytocin administration after the baby delivery and post operative analgesia will be done as per the standard protocol. Patient’s pain assessment will be done at various designated intervals till 14th week. Blood sample will be withdrawn at baseline and at the end of 14th week for gene expression study. The primary objective is to determine and compare the time to first request of analgesia between the two groups  The Secondary Objectives are to determine and compare the NRS pain score at rest and movement at 1st, 6th, 12th, 24th hours and at the end of 6th, 10th and 14th week, total consumption of rescue analgesic in the first 24 hours, Pain detect questionnaire (PDQ) score and Neuropathic pain symptom inventory (NPSI) score and the quality of life using short form (SF)-12 questionnaire at the end of 6th, 10th and 14th week and incidence of chronic persistent post-surgical pain (CPSP) at the end of 14th week. Comparison of mRNA expression of OXTR genes will be done between the two groups at baseline and then at the end of 14th week.
 
Close