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CTRI Number  CTRI/2025/07/091570 [Registered on: 24/07/2025] Trial Registered Prospectively
Last Modified On: 23/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing two types of nerve blocks to reduce pain after caesarean section and which works better. 
Scientific Title of Study   Post-operative analgesic efficacy of usg guided ilioinguinal-iliohypogastric nerve block v/s transversus abdominis plane block following caesarean section under subarachnoid block: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 Alok Raj 
Designation  Junior Resident 
Affiliation  RAJENDRA INSTITUTE OF MEDICAL SCIENCES 
Address  Department of Anesthesiology,Rajendra Institute of Medical Sciences,Bariatu,Ranchi,Jharkhand

Ranchi
JHARKHAND
834009
India 
Phone  8210022953  
Fax    
Email  alokraj1005@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Azizul Haque 
Designation  Associate Professor 
Affiliation  RAJENDRA INSTITUTE OF MEDICAL SCIENCES 
Address  Department of Anesthesiology,Rajendra Institute of Medical Sciences,Bariatu,Ranchi,Jharkhand

Ranchi
JHARKHAND
834009
India 
Phone  9771185861  
Fax    
Email  drazizulhaq61@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Priyanka Shrivastava 
Designation  Assistant Professor 
Affiliation  RAJENDRA INSTITUTE OF MEDICAL SCIENCES 
Address  Department of Anesthesiology,Rajendra Institute of Medical Sciences,Bariatu,Ranchi,Jharkhand

Ranchi
JHARKHAND
834009
India 
Phone  9958912712  
Fax    
Email  shrivastava2911@gmail.com  
 
Source of Monetary or Material Support  
Rajendra Institute of Medical Sciences,Ranchi, Jharkhand, India, pin 834009 
 
Primary Sponsor  
Name  Rajendra Institute of Medical Sciences 
Address  Department of Anesthesiology, Rajendra Institute of Medical Sciences, Ranchi, Jharkhand, India, pin 834009 
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 
Dr Alok Raj  Rajendra Institute of Medical Sciences  Department of Anaesthesiology and Labour Operation Theatre, Rajendra Institute of Medical Sciences, Bariatu, Ranchi 834009
Ranchi
JHARKHAND 		 8210022953

alokraj1005@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, RIMS, Ranchi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Post Operative Cesarean section patients 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ilioinguinal-iliohypogastric nerve block  In patient undergoing C-section will be given ultrasound guided ilioinguinal-iliohypogastric nerve block using 20G IV cannula between external oblique muscle and transversus abdominis muscle locally and after operation using 15ml of 0.25 percent Bupivacaine at 2mg/kg, once on each sides i.e. right and left. This intervention will take approx 10minutes. 
Comparator Agent  Transversus Abdominis Plane Block  In patient undergoing C-section will be given ultrasound guided transversus abdominis plane block using 20G IV cannula between external oblique muscle and transversus abdominis muscle locally and after operation using 15ml of 0.25 percent Bupivacaine at 2mg/kg, once on each side i.e. right and left. This intervention will take approx 10minutes. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  a)The patient giving written and informed consent for study.
b)Patients undergoing C-section will be Primigravida and Multigravida.
c)Patients with ASA grade 2. 
 
ExclusionCriteria 
Details  a)Patients having weight less than 40kg.
b)Patients with deranged coagulation profile.
c)Patients having infection at block site.
d)Patients having allergy to the study drug. 
 
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 
To record the time of requirement of first rescue analgesic.  Visual Analogue Scale Score
3hours post-surgery
6hours post-surgery
12hours post-surgery
24hours post-surgery 
 
Secondary Outcome  
Outcome  TimePoints 
a)To record the hemodynamic parameters-systolic blood pressure, diastolic blood pressure,heart rate, MAP.  Baseline
5minutes after block
10minutes after block
15minutes after block
30minutes after block
45minutes after block
60minutes after block
75minutes after block
90minutes after block
105minutes after block 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   09/08/2025 
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 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  
Effective postoperative analgesia after caesarean section is essential for early recovery, maternal comfort, and newborn care. While spinal (subarachnoid) block is widely used for caesarean delivery, its analgesic effect diminishes over time, often necessitating additional pain control methods.
Ultrasound-guided regional nerve blocks have become valuable tools in multimodal analgesia. Two such techniques—the Transversus Abdominis Plane (TAP) block and the Ilioinguinal-Iliohypogastric (II-IH) nerve block are commonly used to manage somatic pain after lower abdominal surgeries.
The TAP block provides analgesia by anesthetizing the nerves (T6–L1) in the fascial plane between the internal oblique and transversus abdominis muscles, while the II-IH block targets the terminal branches of T12 and L1, supplying the lower abdominal wall. Both blocks have shown effectiveness in reducing postoperative opioid requirements, but their comparative efficacy in caesarean section patients remains uncertain.

This randomized clinical trial aims to compare the postoperative analgesic efficacy of ultrasound-guided II-IH nerve block versus TAP block in women undergoing caesarean section under spinal anesthesia.
 
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