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CTRI Number  CTRI/2024/10/074709 [Registered on: 04/10/2024] Trial Registered Prospectively
Last Modified On: 02/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare two nerve blocks - transversalis fascia plane block and ilioinguinal-iliohypogastric nerve block for controlling pain after caesarean section  
Scientific Title of Study   Comparison of transversalis fascia plane block versus ilioinguinal-iliohypogastric nerve block for postoperative analgesia in patients undergoing caesarean 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 Neeru Luthra  
Designation  Professor, Department of Anaesthesiology  
Affiliation  Dayanand Medical College and Hospital, Ludhiana  
Address  Department of Anaesthesiology, Dayanand Medical College and Hospital, Civil Lines,Ludhiana

Ludhiana
PUNJAB
141001
India 
Phone  9815500960  
Fax    
Email  drneeru1977@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Ravneet Kaur Sidhu  
Designation  PG Resident, Department of Anaesthesiology  
Affiliation  Dayanand Medical College and Hospital, Ludhiana  
Address  Department of Anaesthesiology, Dayanand Medical College and Hospital, Civil Lines,Ludhiana

Ludhiana
PUNJAB
141001
India 
Phone  9915067549  
Fax    
Email  ravneetsidhu1991@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ravneet Kaur Sidhu  
Designation  PG Resident, Department of Anaesthesiology  
Affiliation  Dayanand Medical College and Hospital, Ludhiana  
Address  Department of Anaesthesiology, Dayanand Medical College and Hospital, Civil Lines,Ludhiana

Ludhiana
PUNJAB
141001
India 
Phone  9915067549  
Fax    
Email  ravneetsidhu1991@gmail.com  
 
Source of Monetary or Material Support  
Dayanand Medical College and Hospital, Tagore Nagar, Civil Lines,Ludhiana 141001 Punjab India 
 
Primary Sponsor  
Name  Dayanand Medical College and Hospital  
Address  Tagore Nagar, Civil Lines,Ludhiana 141001 Punjab India 
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 Neeru Luthra   Dayanand Medical College and Hospital   Department of Anaesthesiology,Dayanand Medical College and Hospital,Tagore Nagar, Civil Lines,Ludhiana 141001 Punjab, India
Ludhiana
PUNJAB 		 9815500960

drneeru1977@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Ethics Committee, Dayanand Medical College and Hospital   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: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ilioinguinal-iliohypogastric nerve block   Parturients in group I will be administered ultrasound guided ilioinguinal-iliohypogastric nerve block after caesarean section by injecting 40 ml of 0.2% ropivacaine with 4 mg dexamethasone (20 ml on each side) in fascial plane between internal oblique and transversus abdominis muscle after identification of ilioinguinal and iliohypogastric nerves.The intervention will be continued till the whole study drug is deposited in the fascial plane 
Intervention  Transversalis fascia plane block   Parturients in group T will be administered ultrasound guided transversalis fascia plane block after caesarean section by injecting 40 ml of 0.2% ropivacaine with 4 mg dexamethasone (20 ml on each side) between transversus abdominis muscle and underlying transversalis fascia. The intervention will be continued till the whole study drug is deposited in the fascial plane  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Parturients under American Society of Anaesthesiologists (ASA) class II who are scheduled for elective caesarean section with Pfannenstiel incision under subarachnoid block  
 
ExclusionCriteria 
Details  1.Infection at injection site
2.Patient with known allergy to any of the study drug
3.Coagulation disorder with INR more than 1.5
4.ASA class III and IV patients.
5.Twin pregnancy
6.Emergency caesarean section
7.Placenta previa and accreta
8.Chronic opioid abuse
9.Patient refusal
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Total rescue analgesic requirement  In the first 24 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of NRS scores at predefined intervals   At 0, 2, 4, 6, 8, 12, 16, 20, 24 hours 
Time to first rescue analgesic   In the first 24 hrs 
Patient satisfaction score for pain management   At 24 hrs 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   15/10/2024 
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="1"
Months="6"
Days="3" 
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   Caesarean section is associated with moderate-to-severe postoperative pain. Effective postoperative analgesia after LSCS is essential for early breast feeding and ambulation and has a role to play in decreasing postpartum depression. Transversalis fascia plane (TFP) block and ilioinguinal-iliohypogastric (ILIH) nerve block are regional anaesthesia techniques that have the potential to improve analgesia following caesarean section. This study will help us to determine which block has superior pain management properties.
A prospective, randomized, interventional study will be conducted in 80 American Society of Anaesthesiologists grade II parturients scheduled for elective caesarean section with Pfannenstiel incision under SAB, divided into two groups of 40 each. In group T, TFP block and in group I, ILIH block will be administered using 40 ml of 0.2% ropivacaine with 4mg dexamethasone (20 ml on each side) after completion of caesarean. The surgical site wound infiltration will be done with 10 ml of 0.2 % ropivacaine in both the groups. Postoperatively, monitoring of vitals and assessment of pain will be conducted using Numerical Rating Scale (NRS). Any patient complaining of NRS ≥ 4 will be administered rescue analgesic (Injection tramadol 50mg intravenously). The patient satisfaction score for pain management will be determined by five-point Likert scale. The total rescue analgesic consumption in 24 hours will be compared as a primary outcome and NRS scores, time to first rescue analgesic and patient satisfaction score will be compared for secondary outcomes.
 
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