| CTRI Number |
CTRI/2025/06/088702 [Registered on: 12/06/2025] Trial Registered Prospectively |
| Last Modified On: |
11/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare between two techniques of providing pain relief - caudal and TFP block - in children undergoing inguinal hernia surgery |
|
Scientific Title of Study
|
Comparison of caudal epidural block versus ultrasound guided transversalis
fascia plane block for perioperative analgesia in children undergoing inguinal hernia surgery – A
randomized controlled 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 |
Dr Arun Parthasarathy |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9600129686 |
| Fax |
|
| Email |
p.arun1991@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Parthasarathy |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Manipal
KARNATAKA
576104
India |
| Phone |
9600129686 |
| Fax |
|
| Email |
p.arun1991@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Parthasarathy |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Manipal
KARNATAKA
576104
India |
| Phone |
9600129686 |
| Fax |
|
| Email |
p.arun1991@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba medical college and Kasturba hospital, Manipal, Karnataka - 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Arun Parthasarathy |
| Address |
Department of Anaesthesiology, Kasturba medical college and hospital, Manipal, Karnataka, India - 576104 |
| Type of Sponsor |
Other [Self] |
|
|
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 Arun Parthasarathy |
Kasturba Medical College and Kasturba hospital |
Department of Anaesthesiology, Manipal, 576104
Udupi
KARNATAKA |
9600129686
p.arun1991@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC and KH Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Caudal epidural block |
All participants will receive landmark guided caudal epidural block with 1ml/kg of 0.125% bupivacaine |
| Intervention |
Transversalis fascial plane (TFP) block |
All participants in this group will receive ultrasound guided TFP block with 0.5 ml/kg of 0.125% bupivacaine |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I and II undergoing unilateral inguinal hernia surgery |
|
| ExclusionCriteria |
| Details |
Participant refusal
Absolute contraindications for the block
Additional procedures at different sites |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to first analgesic requirement after surgery (in minutes) |
1,3,6 and 12 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
FLACC scores
total dose of
paracetamol consumed
total number of participants requiring
rescue analgesia
total dose of additional intraoperative fentanyl
requirements
number of participants requiring postoperative tramadol
parental satisfaction scoring |
1,3,6 and 12 hours postoperatively |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="0"
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
|
Surgical repair of inguinal hernia is one of the most common day care surgeries in the pediatric
population. Providing good analgesia is important for early mobilization and discharge from the
hospital. Achieving adequate postoperative analgesia in the pediatric age group is also important in
terms of future pain perception and chronic pain development in the subsequent period. Regional
anaesthesia in children has become increasingly popular over the past few decades. A variety of
peripheral and central nerve blocks have been developed to ensure that perioperative pain can be
effectively controlled.
Caudal anesthesia can be useful in the pediatric population for sub-umbilical procedures, including
inguinal hernia repair, urological interventions, anal atresia repair, and lower extremity procedures. It
can be stand-alone or be a supplement to general anesthesia for these procedures. Caudal
analgesia in lower abdominal surgeries has become unpopular among physicians because of its short
duration of analgesia (4–6) h, and its potential adverse effects including motor block, urine retention
and the accidental dural puncture. Currently, fascial blocks are widely used for postoperative
analgesia in patients scheduled for lower abdominal surgeries.
Transversalis fascia plane block (TFB) was described by Hebbard et al. in 2009 which targets the T12
and L1 spinal nerves. In TFB the local anesthetic is deposited at the level of posterior axillary line in
the layer between the transversus abdominis muscle and its deep investing transversalis fascia.
The analgesic efficacy of TFP block has been demonstrated in adult surgery, including iliac crest bone
graft harvesting, inguinal herniorrhaphy and cesarean section. Very few studies in literature
have demonstrated the efficacy of this block in paediatric population. To our knowledge, no
previous studies have compared the efficacy of this block with caudal epidural block.
We have planned this study to counteract the above challenges faced during caudal and hypothesize
that the analgesia coverage, intraoperative response, pain scores postoperatively in the first 12 hours
in TFB will be comparable to caudal block and can be easily practiced with appropriate availability of
USG and equipment. |