| CTRI Number |
CTRI/2021/01/030775 [Registered on: 27/01/2021] Trial Registered Prospectively |
| Last Modified On: |
22/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to evaluate analgesic efficacy between USG -guided transverse fascia plane block and conventional ilioinguinal/ iliohypogastric nerve block |
|
Scientific Title of Study
|
Comparative study to evaluate analgesic efficacy between USG -guided transverse fascia plane block and conventional ilioinguinal/ iliohypogastric nerve block for inguinal surgeries -Prospective randomized trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ridhima |
| Designation |
Assistant professor |
| Affiliation |
Superspeciality Paediatric hospital and Postgraduate teaching institute |
| Address |
Superspeciality Paediatric hospital and Postgraduate teaching institute,Noida
Superspeciality Paediatric hospital and Postgraduate teaching institute,Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
08054549458 |
| Fax |
|
| Email |
drridhimasharma@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ridhima |
| Designation |
Assistant professor |
| Affiliation |
Superspeciality Paediatric hospital and Postgraduate teaching institute |
| Address |
Superspeciality Paediatric hospital and Postgraduate teaching institute,Noida
Superspeciality Paediatric hospital and Postgraduate teaching institute,Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
08054549458 |
| Fax |
|
| Email |
drridhimasharma@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Ridhima |
| Designation |
Assistant professor |
| Affiliation |
Superspeciality Paediatric hospital and Postgraduate teaching institute |
| Address |
Superspeciality Paediatric hospital and Postgraduate teaching institute,Noida
Superspeciality Paediatric hospital and Postgraduate teaching institute,Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
08054549458 |
| Fax |
|
| Email |
drridhimasharma@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Superspeciality Paediatric hospital and postgraduate teaching institute |
|
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Primary Sponsor
|
| Name |
Super Speciality Paediatric Hospital and Post Graduate Teaching Institute |
| Address |
Super Speciality Paediatric Hospital and Post Graduate Teaching Institute Noida sec 30 201307 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ridhima Sharma |
Superspeciality paediatric institute and Postgraduate teaching institute |
Department of Paediatric Anaesthesia
Second floor
Room number 3
Gautam Buddha Nagar
UTTAR PRADESH |
08054549458
drridhimasharma@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Ultrasound guided ilioinguinal/ iliohypogastric nerve block |
Group II will receive Ilioinguinal/iliohypogastric block. In both the groups, local anaesthetic Inj. Bupivacaine 0.4ml/kg will be given. |
| Intervention |
Ultrasound guided transverse fascia plane block |
Patients will be randomly assigned by use of computer-generated random numbers into one of the groups. Group 1 will receive transversalis fascia plane block. In both the groups, local anaesthetic Inj. Bupivacaine 0.4ml/kg will be given. |
|
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Inclusion Criteria
|
| Age From |
12.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1 Scheduled for inguinal surgeries (inguinal surgery)
2 Age 12 months to 12 years
3. ASA physical status I or II
|
|
| ExclusionCriteria |
| Details |
1 Known contraindication to a peripheral nerve block such as severe coagulopathy
2 Allergy to amide local anesthetics
3 Local infection at the planned injection
4 Refusal by parents/guardians
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
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| Outcome |
TimePoints |
| The primary outcome of the study is to compare the duration of postoperative analgesia (time to first analgesic request) |
The primary outcome of the study is to compare the duration of postoperative analgesia (time to first analgesic request) |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1. Intraoperative and postoperative hemodynamic stability
2. Intraoperative fentanyl consumption
3. Postoperative pain assessed by the FLACC score (children 4years) postoperatively at 0, 30min, 1, 2, 4, 6, 12, 18 and 24 hours
4. Untoward side effects, including nausea, vomiting, hypotension, bradycardia
|
6 months |
|
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Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
27/01/2021 |
| 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 |
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Publication Details
|
Nil |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drridhimasharma@yahoo.com].
- For how long will this data be available start date provided 01-02-2021 and end date provided 01-07-2021?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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Brief Summary
|
Pain is perhaps the most petrified symptoms of surgery, especially in the paediatric age groups which is being tried to alleviate and conquer since ages. Fear of needles and mask, emotional liability and a limited reserve of vital function are the confounding factor, contributing further to the difficulties in dealing with this vulnerable age group. The ability to express distress and discomfort is limited in young children due to difficulty in communication,thus pain is usually underestimated and treated, causing impairment in pulmonary, cardiovascular, gastrointestinal, Neuro-endocrine and metabolic function. Inguinal surgeries are among the most common day care procedure in children.Various modalities have been used to cure postoperative pain.Peripheral nerve blocks with local anesthetics are commonly employed method in subumblical surgeries.Iliogastric and Ilioinguinal nerve blocks (IINB) are used,combined with general anaesthesia for intraoperative supplementation and also as a sole entity for postoperative pain.The IINB has been found to decrease the requirement of analgesics for up to 48hrs after inguinal surgeries.Nowadays USG guided peripheral block are commonly used for effective amelioration of the same and has been regarded as a gold standard for nerve localization in clinical anaesthesia. USG Transeverse fascia plane block (TFP) is the preferred method to reduce the use of opioids and systemic analgesics for postoperative pain management.TFP block provide anaesthesia and analgesia in the inguinal region by blocking the ilioinguinal and iliohypogastric nerves.The ilioinguinal/Iliohypogastric (II/IHB) is a widely used regional anaesthesia technique in inguinal hernia repair surgery.However,this block provides limited analgesia during and after surgery,and the patients feel pain when walking.The transverse fascia plane block is a recently developed technique and several case reports presented its efficacy for inguinal repair surgeries in adult patients.It may block not only ilioinguinal and iliohypogastric nerves but also splanchnic nerves,which is conveyed via thoracolumber fascia and mayprovide better and prolong analgesia. |