| CTRI Number |
CTRI/2021/09/036374 [Registered on: 09/09/2021] Trial Registered Prospectively |
| Last Modified On: |
08/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of two different injections in abdomen for pain relief after hip surgery in less than 1 year old children |
|
Scientific Title of Study
|
Addition of ilio-inguinal block to supra-inguinal fascia iliaca block in infant acetabular surgery improves efficacy of postoperative pain relief: A prospective study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sandeep Madhusudan Diwan |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Sancheti Hospital |
| Address |
Shivaji Nagar
Shivaji Nagar
Pune
MAHARASHTRA
411005
India |
| Phone |
9823029328 |
| Fax |
|
| Email |
sdiwan14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sandeep Madhusudan Diwan |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
SANCHETI HOSPITAL |
| Address |
Shivaji Nagar
Shivaji Nagar
Pune
MAHARASHTRA
411005
India |
| Phone |
9823029328 |
| Fax |
|
| Email |
sdiwan14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sandeep Madhusudan Diwan |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
SANCHETI HOSPITAL |
| Address |
Shivaji Nagar
Shivaji Nagar
Pune
MAHARASHTRA
411005
India |
| Phone |
9823029328 |
| Fax |
|
| Email |
sdiwan14@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sancheti Hospital |
| Address |
11/12 Thube Park 16, Shivajinagar, Pune, Maharashtra 411005 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sandeep Madhusudan Diwan |
Sancheti Hospital |
Department of Anaesthesiology,
11/12 Thube Park 16, Shivajinagar, Pune, Maharashtra 411005
Pune
MAHARASHTRA |
9823029328
sdiwan14@gmail.com |
|
|
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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ULTRASOUND GUIDED SUPRAINGUINAL FASCIA ILIACA BLOCK ALONG WITH ILIOINGUINAL NERVE BLOCK |
AFTER INDUCING GENERAL ANAESTHESIA, ON THE OPERATIVE SIDE, INITIALLY ULTRASOUND GUIDED SUPRAINGUINAL FASCIA ILIACA BLOCK WILL BE PERFORMED USING 0.5 ML/KG OG 0.2% ROPIVACAINE FOLLOWED ILIOINGUINAL NERVE BLOCK 0.2 ML/KG OF 0.2% ROPIVACAINE, ALONG WITH 1 MCG/KG CLONIDINE |
| Comparator Agent |
ULTRASOUND GUIDED SUPRAINGUINAL FASCIA ILIACA BLOCK ONLY |
AFTER INDUCING GENERAL ANAESTHESIA, ON THE OPERATIVE SIDE, INITIALLY ULTRASOUND GUIDED SUPRAINGUINAL FASCIA ILIACA BLOCK WILL BE PERFORMED USING 0.5 ML/KG OF 0.2% ROPIVACAINE ONLY, ALONG WITH 1 MCG/KG CLONIDINE |
|
|
Inclusion Criteria
|
| Age From |
5.00 Month(s) |
| Age To |
12.00 Month(s) |
| Gender |
Both |
| Details |
INFANTS AGED 5-12 MONTHS POSTED FOR ACETABULOPLASTY WILL BE INCLUDED
|
|
| ExclusionCriteria |
| Details |
INFANTS WITH PREEXISTING CARDIAC, NEUROLOGICAL, OR OTHER CONGENITAL AILMENTS WILL BE EXCLUDED
PATIENTS UNDERGOING REDO SURGERIES WILL BE EXCLUDED |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TIME TO FIRST RESCUE ANALGESIC |
Baseline to 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PAIN SCORES AT VARIOUS TIME FRAMES |
Baseline to 48 hours |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2021 |
| 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 |
|
Publication Details
|
ONCE WE FINISH THE STUDY AND PERFORM THE ANALYSIS, WE PLAN TO SUBMIT THE MANUSCRIPT TO A PEER REVIEWED JOURNAL. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomized-controlled trial is aimed to
compare the analgesic efficacy of ultrasound-guided suprainguinal fascia iliaca block only with ultrasound-guided
suprainguinal fascia iliaca block along with ilioinguinal nerve block in
infants between 5-12 months undergoing acetabuloplasty under general
anaesthesia. Blocks will be performed under general
anesthesia. For ultrasound-guided
suprainguinal fascia iliaca block, 0.5 ml/kg 0.2% ropivacaine will be used, and
for ilioinguinal nerve block, 0.2 ml/kg of 0.2% ropivacaine will be used.
1 mcg/kg clonidine will be added to the local
anaesthetic solution. Pain scores will be
noted at 0,6,12,24,48 hrs and compared. The
primary outcome will be time to first analgesic (1 mg/kg tramadol). Pain scores at various time frames will be secondary
outcomes.
|