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CTRI Number  CTRI/2025/02/080921 [Registered on: 19/02/2025] Trial Registered Prospectively
Last Modified On: 14/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare Ilioinguinal-Iliohypogastric Nerve Block and Transversus Abdominis Plane Block for post operative pain relief in open Inguinal Hernia Repair 
Scientific Title of Study   Ultrasound Guided Ilioinguinal-Iliohypogastric Nerve Block Versus Ultrasound Guided Transversus Abdominal Plane Block for Post-Operative Analgesia in Open Inguinal Hernia Repair: A Randomised Controlled 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  Bhagyashri Nemade 
Designation  Junior Resident 
Affiliation  NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital 
Address  Department of Anaesthesiology, NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Hingna Road, Nagpur

Nagpur
MAHARASHTRA
440019
India 
Phone  9503381609  
Fax    
Email  bhagyashrinemade.9503@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Heena Pahuja 
Designation  Professor 
Affiliation  NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital 
Address  Department of Anaesthesiology, NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Hingna Road, Nagpur

Nagpur
MAHARASHTRA
440019
India 
Phone  9823188160  
Fax    
Email  heenapahuja15@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Bhagyashri Nemade 
Designation  Junior Resident 
Affiliation  NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital 
Address  Department of Anaesthesiology, NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Hingna Road, Nagpur

Nagpur
MAHARASHTRA
440019
India 
Phone  9503381609  
Fax    
Email  bhagyashrinemade.9503@gmail.com  
 
Source of Monetary or Material Support  
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital 
 
Primary Sponsor  
Name  NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital 
Address  Department of Anaesthesiology, NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Hingna Road, Nagpur 
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 Bhagyashri Nemade  NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital  4th Floor, Department of Anaesthesiology, NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Hingna Road, Nagpur
Nagpur
MAHARASHTRA 
9503381609

bhagyashrinemade.9503@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee N.K.P Salve Institute of Medical Sciences and Research Center and Lata Mangeshkar Hospital, Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ilioinguinal Iliohypogastric Nerve Block  Inj Ropivacaine 0.25% 10 cc given unilaterally on the side of surgery. The time of block will be taken as 0 hr 
Comparator Agent  Transversus Abdominis Plane Block  Inj Ropivacaine 0.25% 20cc given unilaterally on the side of surgery. The time of block will be taken as 0 hr 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Male 
Details  1. Patient undergoing unilateral inguinal hernia surgeries under subarachnoid block
2. American Society of Anaesthesiology (ASA) physical status I,II, III
3. BMI less than 30 Kg/m2 
 
ExclusionCriteria 
Details  1. H/o allergy to local anaesthetics.
2. Infection around the block site.
3. Patient’s Refusal.
4. Coagulopathy.
5. Chronic opioid use.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare Ultrasound Guided Ilioinguinal- Iliohypogastric nerve block versus Ultrasound Guided Transversus Abdominis Plane block for post-operative analgesia in open inguinal hernia repair in terms of:

Numerical Rating Score for pain assessment

Time of first rescue analgesia

Total analgesic requirement in first 24 hrs.
 
Time of block will be taken as 0 hrs.
Patient will be analysed for the above points at 1, 2, 3, 4, 6, 8, 12, 24 hrs. 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of the complications of Ultrasound Guided Ilioinguinal-Iliohypogastric nerve block and Transverse Abdominis Plane block for post operative analgesia in open inguinal hernia repair with respect to:

1] Vascular puncture

2] Haematoma
 
Time of block will be taken as 0 hrs.
Patient will be analysed for the above points at 1, 2, 3, 4, 6, 8, 12, 24 hrs. 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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 3 
Date of First Enrollment (India)   26/02/2025 
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="6"
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  

Open Inguinal Hernia surgery is one of the most commonly performed procedures across the world and is associated with about 60 percent moderate to severe post operative pain.

 

 This acute postoperative pain without adequate analgesia may lead to persistent postsurgical pain. The incidence of chronic postsurgical pain varies according to surgeries and is 5 percent to 35 percent in hernia surgery.

 

 

For management of pain, in post operative hernia repair, various treatment modalities have been advocated. Most of them have been proved inconsistent. Despite of providing good analgesia, Opioids and NSAIDs are associated with several undesirable side effects.

 

 The major goal in the management of post-operative pain is to use minimal dose of medications to decrease their side effects.

 

Regional nerve block techniques offer a great degree of post-operative pain relief thus facilitating early ambulation and discharge.

 

Transversus abdominis plane contains intercostal nerves (T7-T11), subcostal nerves(T12), iliohypogastric and ilioinguinal nerves(L1)

 

 Transversus abdominis plane block [TAP]  has been extensively used for post operative analgesia after inguinal hernia repair.TAP block being a compartment block provides analgesia to the parietal peritoneum and sensation to anterior and lateral abdominal wall in infra-umbilical surgeries block it requires larger volume.

 

   Ilioinguinal-iliohypogastric nerve block, blocks the branches of T12-L1 and provide effective analgesia in inguinal hernia surgeries.

 

   Local anaesthetic is deposited in the plane between the internal oblique and transverse abdominis muscle in both TAP and IIL/IH block, but at different points along the course of nerve , with local anaesthetic being administered closer to nerve in IIL/IH block.

 

  IIL/IH block being more precise requires lower volume of local anaesthetic and so lesser anaesthetic toxicity, complications and more simplicity and efficacy than TAP block to achieve similar analgesic effect.

 

   There are few studies comparing IIL/IH and TAP block for post oprerative analgesia for inguinal hernia repair but results are conflicting.

 

 Hence, we would like to propose a study for comparison of ultrasound guided IL/IH nerve block and ultrasound guided TAP block for open hernia repair for post operative analgesia.

 

 


 
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