CTRI Number |
CTRI/2023/07/055454 [Registered on: 21/07/2023] Trial Registered Prospectively |
Last Modified On: |
21/07/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Is there any difference in two drugs (dexmedetomidine versus dexamethasone) in ultrasound guided anaesthesia technique (fascia iliaca compartment block) in children undergoing hip and thigh surgeries? |
Scientific Title of Study
|
A randomised controlled trial to compare the efficacy of dexmedetomidine versus dexamethasone as an adjunct to bupivacaine in ultrasound guided supra-inguinal fascia iliaca compartment block in children undergoing hip and thigh surgeries under general anaesthesia. |
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 Ruchir Tyagi |
Designation |
Post graduate first year resident |
Affiliation |
Lady Hardinge Medical College and Associated Hospitals |
Address |
Shaheed Bhagat Singh Marg, Lady Hardinge Medical College, DIZ Area, Connaught Place, New Delhi, Delhi 110001
Central DELHI 110001 India |
Phone |
9584572249 |
Fax |
|
Email |
ruchirtyagi16@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Upma Bhatia Batra |
Designation |
Professor |
Affiliation |
Lady Hardinge Medical College and Associated Hospitals |
Address |
Shaheed Bhagat Singh Marg, Lady Hardinge Medical College, DIZ Area, Connaught Place, New Delhi, Delhi 110001
Central DELHI 110001 India |
Phone |
9868616048 |
Fax |
|
Email |
ubhatia2004@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Upma Bhatia Batra |
Designation |
Professor |
Affiliation |
Lady Hardinge Medical College and Associated Hospitals |
Address |
Shaheed Bhagat Singh Marg, Lady Hardinge Medical College, DIZ Area, Connaught Place, New Delhi, Delhi 110001
Central DELHI 110001 India |
Phone |
9868616048 |
Fax |
|
Email |
ubhatia2004@gmail.com |
|
Source of Monetary or Material Support
|
Lady Hardinge Medical College and Associated Hospitals, connaught place, DIZ area, New Delhi, 110001 |
|
Primary Sponsor
|
Name |
Lady Hardinge Medical College and Associated Hospitals |
Address |
Shaheed Bhagat Singh Marg, Lady Hardinge Medical College, DIZ Area, Connaught Place, New Delhi, Delhi 110001 |
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 Ruchir Tyagi |
Kalawati Saran Childrens Hospital |
Paediatrics Operation Theatre, 3rd floor, Connaught circus, Bangla Sahib Road, DIZ Area, Connaught Place, New Delhi, Delhi 110001 Central DELHI |
9584572249
ruchirtyagi16@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, Lady Hardinge Medical College and Associated Hospitals |
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 |
The efficacy (in terms of duration of postoperative analgesia) of dexamethasone as an adjunct to bupivacaine in ultrasound guided supra-inguinal FICB in children undergoing hip and thigh surgeries under general anaesthesia. |
Group B – will receive 0.75mL/Kg of 0.25% bupivacaine mixed with 2mL normal saline containing 0.1 mg/Kg dexamethasone in suprainguinal ultrasonography guided fascia iliaca compartment block. Duration of intervention 5 to 7 minutes |
Intervention |
The efficacy (in terms of duration of postoperative analgesia) of dexmedetomidine as an adjunct to bupivacaine in ultrasound guided supra-inguinal FICB in children undergoing hip and thigh surgeries under general anaesthesia. |
Group A - will receive 0.75mL/Kg of 0.25% bupivacaine mixed with 2mL normal saline containing 0.5 mcg/Kg dexmedetomidine in suprainguinal ultrasonography guided fascia iliaca compartment block. Duration of intervention 5 to 7 minutes |
|
Inclusion Criteria
|
Age From |
1.00 Year(s) |
Age To |
13.00 Year(s) |
Gender |
Both |
Details |
American Society of Anesthesiologists (ASA) physical status I or II patients of either sex, belonging to age group 1 to 13 years, scheduled for hip or thigh surgery |
|
ExclusionCriteria |
Details |
1. History of any relevant drug allergy
2. Coagulation disorder
3. Infection at the needle insertion site
4. Children with Type 1 Diabetes Mellitus |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Mean duration of postoperative analgesia (in minutes) in children receiving dexmedetomidine or dexamethasone as an adjunct to bupivacaine in supra-inguinal fascia iliaca compartment block for hip or thigh surgery under general anaesthesia. |
24 hours post operatively |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. Mean [Standard Deviation(±SD)] / Median [Interquartile range (IQR)] requirement of rescue analgesics (fentanyl, mcg/Kg) |
24 hours post operatively |
Median (IQR) Modified objective pain scale (MOPS) |
at 1 hour, 3 hours, 6 hours & 24 hours postoperatively |
Proportion of patients developing side effects of the drugs - dexmedetomidine or dexamethasone (dry mouth, hypotension, bradycardia) |
for 24 hours post operatively |
Median (IQR) University of Michigan Sedation Scale (UMSS) |
at 1 hour, 3 hours, 6 hours & 24 hours postoperatively |
Median (IQR) parental satisfaction (Likert scale) |
24 hours post operatively |
|
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
|
Phase 4 |
Date of First Enrollment (India)
|
31/07/2023 |
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="1" Months="4" 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
|
The study will be
conducted only after approval from the institutional ethics committee and will be
registered with the clinical trials registry India (CTRI). A detailed
pre-anaesthetic check-up and investigations will be done for all patients.
Informed consent will be taken from parents/assent from the child (wherever
applicable) before the participation in the study. An
anaesthesiologist with an experience of at least 25 successful supra-inguinal
FICB in children will carry out the procedure. Observation and data collection
will be done by an independent observer, who will be blinded to the drugs
given. Patients will be kept
nil per oral (NPO) for at least 6 hours prior to surgery as per standard
guidelines. Perioperative anaesthetic management will be standardized. The
children will be premedicated with oral midazolam (0.5 mg/Kg) 30 min before the
surgical procedure.
After arrival in the operating room, a 22/24 Gauge (G) peripheral intravenous
catheter will be inserted. Standard monitoring will be applied, including
non-invasive blood pressure (NIBP), electrocardiograph (ECG) with heart rate
(HR) and pulse oximetry (SpO2). Intravenous
(IV) Fentanyl 1 mcg/Kg will
be administered and IV propofol 2-3 mg/Kg will be used for induction. Airway
will be secured by an appropriately sized proseal laryngeal mask airway (PLMA).
The maintenance will be provided by sevoflurane 2 to 2.5% in an equal mix of
oxygen and air. The patient will be administered USG guided supra-inguinal FICB
under all aseptic precautions. The USG probe (M-turbo broadband linear array,
6-13 MHz paediatric probe Sonosite®, Bothell, Washington, USA) will
be sheathed. With the patient in supine position, the probe will be placed just
medial to the anterior superior iliac spine (ASIS) in the sagittal plane. The
superior edge of the transducer will be rotated 30 degrees medially towards the
umbilicus to approximate a parallel course with the ilium curve and then
tilted/toggled laterally to identify internal oblique muscle, transversus
abdominis muscle, fascia iliaca (FI), iliacus muscle and ilium bone. Bow tie
sign formed by the muscle fascia of the sartorius muscle and abdominal muscles
will be identified. Using an in-plane approach, a 22 G, 80-mm Pajunk®
needle will be introduced at the caudal edge of the transducer and advanced in
a cephalad direction under visualization until the tip lies below the FI but
above the iliacus muscle. Using hydro-dissection, the fascia iliaca will be
separated from the iliacus muscle to create a space. After negative aspiration,
confirmation of correct needle tip location will be obtained by hydro-dissection
of the plane with normal saline followed by injection of drug in small
increments with gentle intermittent aspiration. An injection will be considered
successful if spread of LA is observed cranial to the point where the iliacus
muscle dives under the abdominal muscles. Patients in Group A will receive
0.75mL/Kg of 0.25% bupivacaine mixed with 2mL normal saline containing 0.5
mcg/Kg dexmedetomidine and group B will receive 0.75mL/Kg of 0.25% bupivacaine
mixed with 2mL normal saline containing 0.1 mg/Kg dexamethasone. During the
injection, the distribution of local anaesthetic (LA) solution will be observed
as a hypo echoic enlargement on USG. The patient would then be handed over for
surgery. If there will be a change of more than 20% in arterial blood pressure
or heart rate during surgery then IV fentanyl 1mcg/Kg will be given to the
patient. At the end of the surgery, anaesthesia will be terminated and the PLMA
will be removed. Thereafter the patient will be shifted to the post anaesthesia
care unit (PACU). All patients will be administered IV paracetamol 15 mg/Kg 8 hourly
in the postoperative period. The duration of postoperative analgesia, defined
as time (in minutes) from giving of the FICB to the time to the first analgesic
request in the postoperative period will be recorded. Pain will be assessed by
an independent anaesthesiologist using Modified Objective Pain Scale (MOPS)
postoperatively at 1 hour, 3 hours, 6 hours and 24 hours. If the pain
score is more than or equal to 4, IV fentanyl will be given as the rescue analgesic
at a dose of 1mcg/Kg and noted. IV Fentanyl at a dose of 1 mcg/Kg
will be repeated if there is no reduction in pain score after 30 minutes. Total
amount of fentanyl (mcg/kg) administered in 24 hours will be recorded. Any drug
side effects (hypotension, sedation and bradycardia) will also be recorded and
appropriately managed. Patients will also be monitored for local anaesthetic
systemic toxicity (LAST) and any such event will be managed as per American
Society of Regional Anesthesia (ASRA) checklist. Sedation will be
assessed as per University of Michigan Sedation Scale (UMSS) at 1 hour, 3
hours, 6 hours and 24 hours postoperatively. Parent satisfaction will be assessed using a
five-point satisfaction scale 24 hours
postoperatively. |