| 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
|
|
|
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
|
|
|
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 required, comparison
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. |