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CTRI Number  CTRI/2024/02/063086 [Registered on: 23/02/2024] Trial Registered Prospectively
Last Modified On: 22/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   To access the efficacy of transverse abdominis plane block versus ilioinguinal and iliohypogastric nerve block for post operative pain management 
Scientific Title of Study   A comparative evaluation between ultrasound guided transverse abdominis plane nerve block versus ilioinguinal and iliohypogastric nerve block in hernia repair surgeries for post operative pain management. 
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 Priyesh Bhaskar  
Designation  Professor and Head of the Department of Anesthesia 
Affiliation  Career institute of medical science and hospital  
Address  Resident room number - 1 Division -1st Department of Anaesthesia Career Institute of medical sciences and Hospital IIM road Ghaila

Lucknow
UTTAR PRADESH
226013
India 
Phone  7985975077  
Fax    
Email  dr.priyeshlpsc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Priyesh Bhaskar  
Designation  Professor and Head of the Department of Anesthesia 
Affiliation  Career institute of medical science and hospital  
Address  Resident room number - 1 Division -1st Department of Anaesthesia Career Institute of medical sciences and Hospital IIM road Ghaila


UTTAR PRADESH
226013
India 
Phone  7985975077  
Fax    
Email  dr.priyeshlpsc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sapna  
Designation  PG junior resident 
Affiliation  Career institute of medical sciences and hospital  
Address  Anaesthesia Resident room, Department of Anaesthesia, Career Institute of medical sciences and Hospital Iim road ghailla Lucknow

Lucknow
UTTAR PRADESH
226013
India 
Phone  7988789649  
Fax    
Email  Sapnayadav2501@gmail.com  
 
Source of Monetary or Material Support  
Career institute of medical sciences and hospital  
 
Primary Sponsor  
Name  Career institute of medical sciences and hospital  
Address  IIM road, ghaila, Lucknow  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Priyesh bhaskar  Career institute of medical sciences and hospital   Resident room number - 1 Division -1st Department of Anaesthesia
Lucknow
UTTAR PRADESH 		 7985975077

drpriyeshlpsc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Career Institute of Medical Sciences and Hospital, Lucknow   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 
Comparator Agent  Ultrasound guided ilioinguinal and iliohypogastric nerve block   A linear ultrasound probe will be placed transversely on abdomen between the costal margin and iliac crest in the mid axillary line . A peripheral nerve stimulator needle will be introduced from antero-medial position to the posterior and lateral direction with entry point in the skin being 2cms away from the probe. The needle trajectory proceeded in aantero-posterior direction using in-plane technique after confirming the transverse abdominis plane. When proper needle tip placement is confirmed, gentle aspiration for blood is carried out, and if negative, 5 ml of 0.25% levobupivacaine is injected. 
Intervention  Ultrasound guided transverse abdominis plane block  A comparative evaluation between ultrasound guided ilioinguinal and iliohypogastric nerve block versus transverse abdominis plane nerve block in hernia repair surgeries for post operative pain management. After the ilioinguinal nerve and adjacent structures are identified, the overlying skin is prepared with antiseptic solution and a peripheral nerve stimulator needle is advanced using an in-plane approach from a point just below the inferior border of the ultrasound transducer toward the ilioinguinal nerve as it lies within the facial plane between the internal oblique and transverse abdominis muscle and 0.25% levobupivacaine. The route of administration is parenteral, total duration of such intervention will take 20 minutes . 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients who were included into the study:
ASA grade I&II belonging to American Society of Anesthesiologists (ASA) Age group >18 to <65 years
Patient willing to give consent.
Patients who will be able to follow the study protocols. 
 
ExclusionCriteria 
Details  Patients who were excluded from the study:
Age group >18 to <65 years Patients with Child-Pugh ≥ 8/15, INR≥ 1.5,
Grade 3 ascites,
Serum sodium ≤120 mcq/l
2 Body mass index (BMI) ≥ 40 kg/m ,
Known allergy to any of the medicines used Renal or cardiovascular dysfunction Bronchial asthma, Hematological disorders 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Onset & duration of sensory blockade
Duration of post operative analgesia
Patient satisfaction scores
Visual analogue score  		 18 months  
 
Secondary Outcome  
Outcome  TimePoints 
Intra operative narcotic/analgesic requirement
Side effects or complications 		 18 months  
 
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)   20/03/2024 
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="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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response (Others) - 

  4. For what types of analyses will this data be available?
    Response (Others) - 

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 22-07-2023 and end date provided 22-07-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   A comparative evaluation between ultrasound guided transverse abdominis plane nerve block versus ilioinguinal and iliohypogastric nerve block in hernia repair surgeries for post operative pain management.
A nerve block is the injection of numbing medication (local anesthetic ) near specific nerves to decreasepain in a certain part ofbody during and after surgery and for post operative pain management.Transverse abdominis plane block has a potent analgesic effect after hernia repair surgeries.
 Open inguinal hernia surgery is one of the commonly performed surgical procedures which is
associated with substantial postoperative pain and distress. 
  The use of local anesthetic for blocks/infiltration is associated with a shorter intra-
 hospital recovery, lesser morbidity, and overall costs. Due to abdominal wall incision peripheral nerve blocks such as transversus abdominis plane (TAP) block and ilioinguinal & iliohypogastric (II&IH) nerve blocks have been described in the literature as means to
alleviate pain. 
  Among all drugs and techniques, TAP and II&IH blocks are effective and easy to perform with least complications. Infiltration of local anesthetic also decrease postoperative pain and opioid demand with its resultant complications such as nausea, vomiting, and respiratory
depression. It also delays the time to rescue analgesic administration.
  Anatomically, the sensory nerve supply of the inguinal region is from the T12–L2 nerves. The ilioinguinal and iliohypogastric nerves (branches of T12 and L1) are located between the internal abdominal oblique and transverse abdominis muscles just superior to the anterior superior iliac spine. Medially, the ilioinguinal and iliohypogastric nerves penetrate the internal abdominal oblique abdominal muscle to lie between the internal inguinal ring and the external oblique muscle.
 Peripheral nerve blocks such as transversus abdominis plane (TAP) block, abdominal field blocks, and ilioinguinal/iliohypogastric (IIIH) nerve blocks have been described in the literature as means to alleviate pain due to abdominal wall incision.
Repair of inguinal hernia is one of the most commonly performed procedures with most of them being performed on a day surgery center. During the first 24 h after surgery, Ultrasound guided Transverse abdominis plane(a compartment block)is purposed to be superior to Ultrasound guided ilinguinal & iliohypogastric (a truncal block)in terms of the opioid-sparing
effect provide significantly better analgesia.
A growing number of studies have compared these 2 techniques in analgesia for inguinal hernia repair with variable outcomes. To reconcile these conclusions, we conducted this meta-analysis and systematic review to summarize the current evidence and compare the analgesic efficacy and side effects of II and IH block versus TAP block in adult patients undergoing abdominal surgeries.
Levobupivacaine is an s-enantiomer of the long-acting local anaesthetic bupivacaine, which, although currently the most widely used agent in surgery and obstetrics, is associated with potentially fatal cardiotoxicity.Levobupivacaine is less arrhythmogenic than the same dose range of bupivacaine in healthy volunteers. The most common adverse event associated with levobupivacaine treatment is hypotension.
 
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