Clinical trial NCT04782778: Comparison of Supraclavicular and Costoclavicular Brachial Plexus Blocks in Pediatrics
Official title: Comparison of Ultrasound-Guided Supraclavicular and Costoclavicular Brachial Plexus Blocks in Pediatric Patients Undergoing Unilateral Upper Exremity Surgery: A Randomized Controlled Double-Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Local
Postoperative Pain
Keywords: Postoperative Analgesia
Upper Extremity Surgery
Supraclavicular Block
Costoclavicular Block
Brachial Plexus Block
Ultrasound Guidance
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 58
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RANDOMISED DOUBLE BLINDED INTERVENTIONAL
Primary purpose: SCREENING

Brief summary: In upper extremity surgeries, the brachial plexus block can be performed with different techniques at various levels depending on the proximal and distal level of the surgery.

As an alternative to the infraclavicular brachial plexus block, which has been used for many years and which we routinely perform to every pediatric patient under general anesthesia; Costoclavicular block is recommended due to its advantages such as short application time, single injection and sufficient ultrasound imaging, and its use is becoming widespread. There are studies comparing these two methods. However in this study, we aim to compare the postoperative analgesic effects of US-guided costoclavicular technique with US-guided supraclavicular technique, which is more common for many years and is performed 2-3 cm proximal to the costoclavicular block area.

During the block application, the US imaging time, the difficulty level of needle imaging, the number of maneuvers required to reach the target image, whether additional maneuvers are required according to the local anesthetic distribution, the success of the block and the duration of the surgery, the total application time of the block and the duration of general anesthesia will be recorded. Mean arterial pressure and heart rate will be recorded at 30-minute intervals during the surgery. Standardized for pediatric patients The FLACC and Wong-Baker pain scores will be followed first 24 hours after surgery. The patient will be examined for pain, motor and sensation, and analgesic doses will be recorded if used. Time to first pain identification, duration of sleep, patient and surgeon satisfaction will be recorded.

The rarely onset of hemidiaphragmatic paralysis during supraclavicular block reduces its use. Costoclavicular block could be a safe and effective alternative. One of our seconder objectives is to assess the incidence of hemidiaphragmatic paralysis following ultrasound-guided supraclavicular block and compare it to that of costoclavicular block. For this purpose diaphragmatic excursion is visualized by M-mode ultrasonography 30 minutes after extubation. In B-mode, the diaphragm thickness measurement at the end of expiratory and inspiratory end is recorded and the diaphragm thickness fraction is calculated. Absence of diaphragmatic excursion during a sniff test or sighing defined the hemidiaphragmatic paralysis.

Detailed description: Peripheral nerve blocks; It is widely used in daily practice for anesthesia or as a part of multimodal analgesia in most surgical procedures. In upper extremity surgeries, the brachial plexus block can be performed with different techniques at various levels depending on the proximal and distal level of the surgery. In this study, the aim is to compare postoperative analgesic effects of these two ultrasound-guided techniques in pediatric patients.

As an alternative to the infraclavicular brachial plexus block, which has been used for many years and which we routinely perform to every pediatric patient under general anesthesia; Costoclavicular block is recommended due to its advantages such as short application time, single injection and sufficient ultrasound imaging, and its use is becoming widespread. There are studies comparing these two methods. However, we aim to compare the costoclavicular technique with the supraclavicular technique, which is more common for many years and is performed 2-3 cm proximal to the costoclavicular block area. Thus demonstrate the safety of upper extremity blocks, which is an important part of multimodal analgesia, and to determine the most ideal technique in the pediatric patient group who will undergo upper extremity surgery.

During the block application, the US imaging time, the difficulty level of needle imaging, the number of maneuvers required to reach the target image, whether additional maneuvers are required according to the local anesthetic distribution, the success of the block and the duration of the surgery, the total application time of the block and the duration of general anesthesia will be recorded. Mean arterial pressure and heart rate will be recorded at 30-minute intervals during the surgery. Standardized for pediatric patients The FLACC and Wong-Baker pain scores will be followed first 24 hours after surgery. The patient will be examined for pain, motor and sensation, and analgesic doses will be recorded if used. Time to first pain identification, duration of sleep, patient and surgeon satisfaction will be recorded.

The rarely onset of hemidiaphragmatic paralysis during supraclavicular block reduces its use. Costoclavicular block could be a safe and effective alternative. One of our seconder objectives is to assess the incidence of hemidiaphragmatic paralysis following ultrasound-guided supraclavicular block and compare it to that of costoclavicular block. For this purpose diaphragmatic excursion is visualized by M-mode ultrasonography 30 minutes after extubation. In B-mode, the diaphragm thickness measurement at the end of expiratory and inspiratory end is recorded and the diaphragm thickness fraction is calculated. Absence of diaphragmatic excursion during a sniff test or sighing defined the hemidiaphragmatic paralysis.

Eligibility criteria: Inclusion Criteria:

* Undergoing unilateral upper extremity surgery (distal midhumerus).
* ASA(American Society of Anesthesiology) 1-3
* Receiving family consent from the parents that they accept regional analgesia

Exclusion Criteria:

* Parents refusal
* Infection on the local anesthetic application area
* Infection in the central nervous system
* Coagulopathy
* Brain tumors
* Known allergy against local anesthetics
* Anatomical difficulties
* Syndromic patient

Primary outcomes:
measure: Total block application time
timeFrame: Up to 15 minutes
Secondary outcomes:
measure: Ideal USG guided brachial plexus cords visualization/needle pathway planning time
timeFrame: Up to 15 minutes
measure: Needle tip and shaft imaging visualization
timeFrame: Up to 15 minutes
measure: Number of needle maneuvers
timeFrame: Up to 15 minutes
measure: Total procedure difficulty according to the anesthesiologist
timeFrame: Up to 15 minutes
measure: Patient number requiring rescue analgesics
timeFrame: Intraoperative 2-4 hours
measure: Face, Legs Activity, Cry, Consolability (FLACC) scores
timeFrame: Up to 24 hours
measure: Wong Baker FACES scale
timeFrame: Up to 24 hours
measure: Motor blockade physical examination
timeFrame: Up to 24 hours
measure: Sensorial blockade physical examination
timeFrame: Up to 24 hours
measure: Complications/side effects
timeFrame: Up to first week
measure: Incidence of symptomatic/asymptomatic postprocedural phrenic nerve paralysis
timeFrame: Up to 2 hours
measure: Time to postoperative first pain
timeFrame: Up to 24 hours
measure: Patient number who require additional analgesic
timeFrame: Up to 24 hours
measure: Duration of sleep
timeFrame: Up to 24 hours
measure: Family satisfaction
timeFrame: Up to 24 hours
measure: Surgeon satisfaction
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
state: Fatih
Study officials:
affiliation: Istanbul University
name: Meltem Savran Karadeniz, Assoc.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Songthamwat B, Karmakar MK, Li JW, Samy W, Mok LYH. Ultrasound-Guided Infraclavicular Brachial Plexus Block: Prospective Randomized Comparison of the Lateral Sagittal and Costoclavicular Approach. Reg Anesth Pain Med. 2018 Nov;43(8):825-831. doi: 10.1097/AAP.0000000000000822.
citation: Grape S, Pawa A, Weber E, Albrecht E. Retroclavicular vs supraclavicular brachial plexus block for distal upper limb surgery: a randomised, controlled, single-blinded trial. Br J Anaesth. 2019 Apr;122(4):518-524. doi: 10.1016/j.bja.2018.12.022. Epub 2019 Jan 31.
citation: Sivashanmugam T, Maurya I, Kumar N, Karmakar MK. Ipsilateral hemidiaphragmatic paresis after a supraclavicular and costoclavicular brachial plexus block: A randomised observer blinded study. Eur J Anaesthesiol. 2019 Oct;36(10):787-795. doi: 10.1097/EJA.0000000000001069.
citation: Luo Q, Yao W, Chai Y, Chang L, Yao H, Liang J, Hao N, Guo S, Shu H. Comparison of ultrasound-guided supraclavicular and costoclavicular brachial plexus block using a modified double-injection technique: a randomized non-inferiority trial. Biosci Rep. 2020 Jun 26;40(6):BSR20200084. doi: 10.1042/BSR20200084.