To study the success rate of a new type of upper limb block in children using ultrasound
- Conditions
- Syndactyly, unspecified,
- Registration Number
- CTRI/2020/03/024234
- Lead Sponsor
- All India Institute of Medical Sciences New Delhi
- Brief Summary
HYPOTHESIS
Recent literature reveals that costoclavicular space has been emerging as a better block site and ultrasound guided costoclavicular brachial plexus block has been described in adults for surgeries of elbow joint and forearm.Advantages of costoclavicular block include cords are clustered together lateral to the axillary artery, consistent relation to one another and to the axillary artery, single needle pass and higher success rate. Our aim is to evaluate whether we can have the same benefits in paediatric population as obtained in adults for ultrasound guided costoclavicular block.
AIMS & OBJECTIVES
AIM
To To evaluate the effectiveness of costoclavicular block in paediatric population.
PRIMARY OBJECTIVE
To study the success rate of costoclavicular block in paediatric patients
SECONDARY OBJECTIVES
1) Describe the relationship of 3 cords of brachial plexus to axillary artery
2)To assess the ease of needling
3)Incidence of complications related to block
4)Time for first analgesic requirement
METHODOLOGY
STUDY DESIGN
A prospective observational study
STUDY SETTING
This study will be conducted at All India Institute of Medical Sciences, New Delhi.
STUDY POPULATION
30 paediatric patients between 2 to 12 years of age, of ASA status 1 or 2 undergoing upper limb (below elbow) surgeries in All India institute of Medical sciences, New Delhi, will be considered for recruitment in this study.
INCLUSION CRITERIA
1)Age 2-12 years
2)Patients scheduled for elective upper limb surgery (below elbow)
3)ASA Status I or II
EXCLUSION CRITERIA
1)Refusal by Parents
2)Known allergy to local anaesthetics
3)Local site infection
4)Bleeding diathesis
Pre-operative assessment
All patients will be recruited one day before the day of surgery. After getting informed and written consent from parents, a routine pre-anaesthetic assessment will be done. The costoclavicuar block procedure as well as CHEOPS pain score will be explained. The patients will be instructed to stay nil per oral (6 hours for solids and 2 hours for clear liquids) prior to surgery.
Intraoperative management
After shifting the patient inside the operating room, patient monitoring will be done as per ASA standards- pulse oximeter, non-invasive blood pressure monitoring and ECG.
INDUCTION: After checking the baseline vitals, the patient will be induced with 100 % O2 and 8% sevoflurane. Once the patient is induced, intravenous line will be secured with an appropriate size cannula and inj fentanyl 1 mcg/kg will be given. Airway patency will be maintained with an appropriate size Laryngeal Mask Airway.
MAINTENANCE: All the patients will be maintained by O2, Air and sevoflurane to maintain a FiO2 of 50% and a MAC of 0.8 to 1.
PERFORMIMG THE BLOCK: Baseline values of pulse rate, non-invasive blood pressure (NIBP), perfusion index and skin temperature will be recorded before performing the block.
The child will be placed in a supine position with the surgical limb in 90 degree abduction. The high frequency linear ultrasound probe will initially be placed on top of the middle third of the clavicle. Subsequently, the probe will be translocated to the inferior border of the clavicle and positioned in the medial infraclavicular fossa. In the costoclavicular space, the axillary artery will be identiï¬ed underneath the subclavius muscle and the three cords of the brachial plexus will be visualized lateral to the artery. After the preliminary scan, the probe will be aseptically prepared by covering the surface with nonsterile ultrasound gel, slipping it into the sterile glove, which will then be covered with sterile gel. The insertion site will be disinfected. Subsequently, the axillary artery and the cords will once again be identified. The block needle used will be a 22G 5 cm needle which is attached with nerve stimulator. Using an in-plane technique and a lateral-to-medial direction, the block needle will be advanced (with pleura continuously visualized) until its tip be located in the middle of all three cords. Ropivacaine 0.5% at the dose of 0.5mL/kg will be injected when the response is between 0.3 -0.5 mA. Block success will be assessed by monitoring hemodynamic response (heart rate and blood pressure) to surgical incision 15 minutes after local anaesthetic injection. Rise in heart rate and blood pressure more than 20% from base will be considered as block failure and the same will be treated with fentanyl 1 µg/kg iv.
The investigator supervising the block will assess:
SONO ANATOMY OF COSTOCLAVICULAR SPACE- depth of axillary artery and brachial plexus from skin, minimum distance between brachial plexus and pleura, maximum lateral distance between axillary artery and brachial plexus, position of cords around axillary artery and 3-point Likert scale of brachial plexus image
NEEDLE PERFORMANCE- needling time, number of skin punctures done, number of needle redirections done, amount of current used for nerve stimulation (mA) and nerve stimulator motor response elicited
INCIDENCE OF COMPLICATIONS- arterial/ venous puncture, hematoma, pleural puncture, Horner’s syndrome and diaphragmatic palsy
EFFECTIVENESS OF BLOCK- time required for first analgesia, intra operative and post-operative total fentanyl requirement.
Postoperative management
After the surgery is over, all patients will be shifted to the post anaesthesia care unit [PACU]. ECG, NIBP and SpO2 will be monitored and oxygen will be provided via face mask .
Pain score- CHEOPS will be assessed at 15 min, 30 min, 2 hr,4 hr, 6 hr and 8 hr. If CHEOPS score is more than 4, rescue fentanyl of dose 0.5mg/kg and paracetamol 15mg/kg every 6 hours will be given.
REVIEW OF LITERATURE
In a study by Leurcharusmee et al, randomized comparison between costoclavicular and paracoracoid ultrasound-guided infraclavicular block for upper limb surgery was done. Ninety patients undergoing upper limb surgery at or distal to the elbow were randomly allocated to receive a costoclavicular (n = 45) or paracoracoid (n = 45) ultrasound-guided infraclavicular brachial plexus block. Both groups received a 35-mL mixture of 1% lidocaine– 0.25% bupivacaine with epinephrine 5 mcg mL-1. In the costoclavicular group, local anesthetic was injected into the costoclavicular space in the middle of the three cords of the brachial plexus. In the paracoracoid group, local anesthetic was deposited dorsal to the axillary artery in the lateral infraclavicular fossa. A blinded observer recorded the block onset time (primary endpoint), success rate (i.e., surgical anaesthesia), block-related pain scores, as well as the incidence of hemidiaphragmatic paralysis. Performance time and the number of needle passes were also recorded during the performance of the block. The total anaesthesia-related time was deï¬ned as the sum of the performance and onset times. Results The mean (SD) onset times were comparable between the costoclavicular and paracoracoid groups [16.0 (7.5) min vs 16.8 (6.2) min, respectively; mean difference, 0.8; 95% conï¬dence interval, -2.3 to 3.8; P = 0.61]. Furthermore, no intergroup differences were found in terms of performance time (P = 0.09), total anaesthesia-related time (P = 0.90), surgical anaesthesia (P[0.99), and hemidiaphragmatic paralysis (P>0.99). The paracoracoid technique required marginally fewer median [interquartile range] needle passes than the costoclavicular technique (2 [1-4] vs 2 [1-6], respectively; P = 0.048); however, procedural pain was comparable between the two study groups. This study showed that costoclavicular and paracoracoid ultrasound-guided infraclavicular blocks resulted in similar onset times. Furthermore, no intergroup differences were found in terms of performance times and success rates. Future dose-ï¬nding trials are required to elucidate the minimum effective volume of local anesthetic for costoclavicular infraclavicular blocks.
In the study by Songthamwat et al, prospective randomized comparison of the lateral sagittal and costoclavicular approach was done. Forty patients undergoing elective upper extremity surgery under brachial plexus block were randomized to receive either the lateral sagittal(Gp-LS,n=20) or costoclavicular approach (Gp-CC, n = 20) for infraclavicular brachial plexus block. Twenty-five milliliters of 0.5% ropivacaine was used for the brachial plexus block in both study groups. Sensory motor blockade of the ipsilateral median, radial, ulnar, and musculocutaneous nerves was assessed by a blinded observer at regular intervals for 45minutes after the block. Sensory block was assessed using a verbal rating scale (0–100) and motor block using a 3-point qualitative scale (0–2). Onset of sensory (primary outcome variable) and motor blockade was defined as the time it took to achieve a sensory verbal rating scale of 30 or less and motor grade of 1 or less, respectively. Time to readiness for surgery was defined as the time it took to achieve a sensory score of 30 or less and motor grade of 1 or less in all the 4 nerves tested. The overall sensory onset time (median [interquartile range]) was significantly faster(P=0.004)in Gp-CC(10[10–26.25]minutes) than in Gp-LS(20[15–30]minutes).The overall sensory score was significantly lower in Gp-CC than in Gp-LS at 5 (P<0.001),10(P=001),15(P=0.001), and 20 (P = 0.04)minutes after the brachial plexus block. The overall motor score was significantly lower(P=0.009) in Gp-CC than in Gp-LS at 10minutes after the brachial plexus block. There were more (P = 0.04) patients with complete sensory-motor blockade at 20 minutes after the brachial plexus block in Gp-CC (25%) than in Gp-LS (0%). Time to readiness for surgery was also significantly faster (P = 0.002) in Gp-CC (10 [10–26.5] minutes) than in Gp-LS (20 [15–30] minutes). This study showed the costoclavicular approach for infraclavicular brachial plexus block produces faster onset of sensory blockade and earlier readiness for surgery than the lateral sagittal approach.
BIBLIOGRAPHY
1. Macfarlane, Alan, and Keith Anderson. “Infraclavicular Brachial Plexus Blocks.â€
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- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
1.Age 2-12 years 2.Patients scheduled for elective upper limb surgery (below elbow) 3.ASA Status I or II.
- 1.Refusal by Parents 2.
- Known allergy to local anaesthetics 3.
- Local site infection 4.
- Bleeding diathesis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Success rate of costoclavicular block in paediatric patients 15 minutes after giving block
- Secondary Outcome Measures
Name Time Method Describe the relationship of 3 cords of brachial plexus to axillary artery time -0 (while giving block) Assess the ease of needling Time-0 (while giving block) Incidence of vascular puncture, pleural puncture Time-0( while giving block) Pain score 10 min, 30 min, 2,4,6 and 8 hours
Trial Locations
- Locations (1)
All India Institute of Medical Sciences, New Delhi
🇮🇳Delhi, DELHI, India
All India Institute of Medical Sciences, New Delhi🇮🇳Delhi, DELHI, IndiaDr Ashwin MPrincipal investigator8319736508ashwinmani88@gmail.com