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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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