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?
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2023/07/055454
- Brief Summary
The study will beconducted only after approval from the institutional ethics committee and will beregistered with the clinical trials registry India (CTRI). A detailedpre-anaesthetic check-up and investigations will be done for all patients.Informed consent will be taken from parents/assent from the child (whereverapplicable) before the participation in the study. Ananaesthesiologist with an experience of at least 25 successful supra-inguinalFICB in children will carry out the procedure. Observation and data collectionwill be done by an independent observer, who will be blinded to the drugsgiven. Patients will be keptnil per oral (NPO) for at least 6 hours prior to surgery as per standardguidelines. Perioperative anaesthetic management will be standardized. Thechildren will be premedicated with oral midazolam (0.5 mg/Kg) 30 min before thesurgical procedure.After arrival in the operating room, a 22/24 Gauge (G) peripheral intravenouscatheter will be inserted. Standard monitoring will be applied, includingnon-invasive blood pressure (NIBP), electrocardiograph (ECG) with heart rate(HR) and pulse oximetry (SpO2). Intravenous(IV) Fentanyl 1 mcg/Kg willbe administered and IV propofol 2-3 mg/Kg will be used for induction. Airwaywill 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 ofoxygen and air. The patient will be administered USG guided supra-inguinal FICBunder all aseptic precautions. The USG probe (M-turbo broadband linear array,6-13 MHz paediatric probe Sonosite®, Bothell, Washington, USA) willbe sheathed. With the patient in supine position, the probe will be placed justmedial to the anterior superior iliac spine (ASIS) in the sagittal plane. Thesuperior edge of the transducer will be rotated 30 degrees medially towards theumbilicus to approximate a parallel course with the ilium curve and thentilted/toggled laterally to identify internal oblique muscle, transversusabdominis muscle, fascia iliaca (FI), iliacus muscle and ilium bone. Bow tiesign formed by the muscle fascia of the sartorius muscle and abdominal muscleswill 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 ina cephalad direction under visualization until the tip lies below the FI butabove the iliacus muscle. Using hydro-dissection, the fascia iliaca will beseparated from the iliacus muscle to create a space. After negative aspiration,confirmation of correct needle tip location will be obtained by hydro-dissectionof the plane with normal saline followed by injection of drug in smallincrements with gentle intermittent aspiration. An injection will be consideredsuccessful if spread of LA is observed cranial to the point where the iliacusmuscle dives under the abdominal muscles. Patients in Group A will receive0.75mL/Kg of 0.25% bupivacaine mixed with 2mL normal saline containing 0.5mcg/Kg dexmedetomidine and group B will receive 0.75mL/Kg of 0.25% bupivacainemixed with 2mL normal saline containing 0.1 mg/Kg dexamethasone. During theinjection, the distribution of local anaesthetic (LA) solution will be observedas a hypo echoic enlargement on USG. The patient would then be handed over forsurgery. If there will be a change of more than 20% in arterial blood pressureor heart rate during surgery then IV fentanyl 1mcg/Kg will be given to thepatient. At the end of the surgery, anaesthesia will be terminated and the PLMAwill be removed. Thereafter the patient will be shifted to the post anaesthesiacare unit (PACU). All patients will be administered IV paracetamol 15 mg/Kg 8 hourlyin the postoperative period. The duration of postoperative analgesia, definedas time (in minutes) from giving of the FICB to the time to the first analgesicrequest in the postoperative period will be recorded. Pain will be assessed byan independent anaesthesiologist using Modified Objective Pain Scale (MOPS)postoperatively at 1 hour, 3 hours, 6 hours and 24 hours. If the painscore is more than or equal to 4, IV fentanyl will be given as the rescue analgesicat a dose of 1mcg/Kg and noted. IV Fentanyl at a dose of 1 mcg/Kgwill be repeated if there is no reduction in pain score after 30 minutes. Totalamount of fentanyl (mcg/kg) administered in 24 hours will be recorded. Any drugside effects (hypotension, sedation and bradycardia) will also be recorded andappropriately managed. Patients will also be monitored for local anaestheticsystemic toxicity (LAST) and any such event will be managed as per AmericanSociety of Regional Anesthesia (ASRA) checklist. Sedation will beassessed as per University of Michigan Sedation Scale (UMSS) at 1 hour, 3hours, 6 hours and 24 hours postoperatively. Parent satisfaction will be assessed using afive-point satisfaction scale 24 hourspostoperatively.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 60
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.
- History of any relevant drug allergy 2.
- Coagulation disorder 3.
- Infection at the needle insertion site 4.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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
Trial Locations
- Locations (1)
Kalawati Saran Childrens Hospital
🇮🇳Central, DELHI, India
Kalawati Saran Childrens Hospital🇮🇳Central, DELHI, IndiaDr Ruchir TyagiPrincipal investigator9584572249ruchirtyagi16@gmail.com