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CTRI Number  CTRI/2025/08/093438 [Registered on: 21/08/2025] Trial Registered Prospectively
Last Modified On: 20/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Pain Management in Children Having Hernia Surgery: A Comparison of Two Nerve Blocks 
Scientific Title of Study   Comparison of analgesic efficacy of ultrasound-guided transversus abdominis plane block and erector spinae plane block in children undergoing unilateral open inguinal hernia repair under general anaesthesia; a single-centre, prospective, parallel-group, randomized comparative study. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anjum Naz 
Designation  Professor 
Affiliation  Aiims Kalyani 
Address  Anesthesia department Aiims kalyani Saguna, NH- 34 Connector, Basantapur, Kalyani, 741245

Nadia
WEST BENGAL
741245
India 
Phone  7070888537  
Fax    
Email  anjum.anesth@aiimskalyani.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Anjum Naz 
Designation  Professor 
Affiliation  Aiims Kalyani 
Address  Anesthesia Department Aiims kalyani Saguna, NH-34, Connector Basantapur, Kalyani

Nadia
WEST BENGAL
741245
India 
Phone  7070888537  
Fax    
Email  anjum.anesth@aiimskalyani.edu.in  
 
Details of Contact Person
Public Query
 
Name  Keneiziengunuo Joice Rutsa 
Designation  Junior Resident 
Affiliation  Aiims Kalyani 
Address  Aiims Kalyani Anesthesia Department Saguna, NH-34, Connector Basantapur, Kalyani
RUPALI VILLA Room no 403 Goragacha road KALYANI, WEST BENGAL 741245 India Rupali Villa
Nadia
WEST BENGAL
741245
India 
Phone  7070888537  
Fax    
Email  Keneiziengunuo.anesth_acjr25@aiimskalyani.edu.in  
 
Source of Monetary or Material Support  
Aiims Kalyani Saguna, NH-34 Connector, Basantapur, Kalyani, West Bengal 741245 
 
Primary Sponsor  
Name  AIIMS KALYANI 
Address  AIIMS KALYANI, Saguna, NH-34 Conncetor, Basantapur, NADIA WEST BENGAL 741245 
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 Keneiziengunuo Joice Rutsa  AIIMS Kalyani  Anestheisa Department Saguna, NH- 34 Connector, Basantapur, Kalyani, NADIA WEST BENGAL 741245
Nadia
WEST BENGAL 
7070888537

keneiziengunuo.anesth_acjr25@aiimskalyani.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Analgesic efficacy erector spinae plane block in children undergoing unilateral open inguinal hernia repair under general anaesthesia  In Group E, with patient in lateral position, probe will be placed longitudinally in the midline at T8 level. Sliding the probe laterally by 1 cm towards the side of surgery, we will visualize the hyperechoic T8 transverse process, along with the two muscles of the back, namely Trapezius and Erector Spinae , superficial to it. We will insert 5 cm echogenic block needle in plane to the probe in cephalocaudad direction, till we hit the tip of transverse process. Confirmation of proper position of needle will be done by injection of 2-5 ml of normal saline 0.9% in the space between the ES and transverse process.Injection 0.25 % Bupivacaine 0.5 ml/ kg will be administered and drug deposition will be visualised as lifting up of the ES muscle. 
Comparator Agent  Analgesic efficacy of ultrasound-guided transversus abdominis plane block in children undergoing unilateral open inguinal hernia repair under general anaesthesia  In Group T, with patient in supine position, probe will be placed transversely between the costal margin above and iliac crest below, on the side of surgery. The three muscles of anterior abdominal wall namely, External Oblique , Internal Oblique and Tranversus abdominis will be visualised as 3 hypoechoic bands. Appropriately sized echogenic block needle will be inserted in plane to the probe under USG guidance direct visualisation till the space between IO and TA i.e, Transversus Abdominis Plane will be reached. Confirmation of proper position of needle will be done by injection of 2-5 ml of normal saline 0.9%. Injection 0.25 % Bupivacaine 0.5 ml/ kg will then be administered and drug deposition will be visualised as splitting of the TAP.  
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  - Paediatric patients aged one to eight years, undergoing open unilateral inguinal hernia repair under GA.
- American Society of Anesthesiologists (ASA) performance status 1 and 2 patients.
 
 
ExclusionCriteria 
Details  - Refusal to participate in the study.
- Patients with coagulopathy, local infection or hematoma in the block target area.
- Patients with allergy to local anesthetic (LA) agents or any of the drugs used in the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of postoperative pain, documented as Face, Legs, Activity, Cry, Consolability (FLACC) scale after ESPB and TAPB in pediatric patients undergoing unilateral open inguinal hernia surgery under GA.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
- Comparison of intraoperative opioid requirement after surgical incision in pediatric patients undergoing unilateral open inguinal hernia surgery who received ESPB & TAPB.
- Comparison of time to first rescue analgesia required in children undergoing unilateral open inguinal hernia surgery who received ESPB & TAPB.
- Comparison of total parenteral analgesic consumption in pediatric patients undergoing unilateral open inguinal hernia surgery who received ESPB & TAPB.
- Assessment of the impact of ESPB & TAPB on postoperative nausea & vomiting (PONV), length of hospital stays & parental satisfaction.
 
Baseline 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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/ Phase 4 
Date of First Enrollment (India)   01/09/2025 
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="2"
Months="0"
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 - NO
Brief Summary  

Open inguinal hernia repair is one of the common surgical treatments, particularly in pediatric patients. Due to the potential for considerable postoperative pain, especially in the early recovery period because of extensive dissection and manipulation of muscles (Internal Oblique and Transversus abdominis) and fascial layers, achieving appropriate analgesia is crucial after such surgeries. Severe post operative pain might occur after hernia surgery due to entrapment of nerves like ilioinguinal, iliohypogastric as well as genital branch of genitofemoral nerve. In addition, inflammatory response after surgery can lead to delayed recovery, impaired wound healing, increased stress response, increased risk of infections, deep vein thrombosis and reduced parental satisfaction.

The quest for effective, safe, and opioid-sparing analgesia in paediatric anaesthesia has led to the exploration of newer regional blocks. In recent years, TAPB and ESPB have emerged as reliable alternatives for postoperative pain management in lower abdominal surgeries, including inguinal hernia repairs. However, choosing appropriate block still remains a challenge. There is various evidence available against both of these blocks.

Primary objectives include comparison of postoperative pain, documented as Face, Legs, Activity, Cry, Consolability (FLACC) scale after ESPB and TAPB in pediatric patients undergoing unilateral open inguinal hernia surgery under GA.

Secondary objectives being comparison of intraoperative opioid requirement after surgical incision, comparison of time to first rescue analgesia requiredcomparison of total parenteral analgesic consumption, assessment of the impact of ESPB and TAPB on postoperative nausea and vomiting (PONV), length of hospital stays and parental satisfaction.


 
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