Clinical trial NCT04786756: Comparison of Lateral and Medial Approaches to Costoclavicular Brachial Plexus Block in Pediatrics
Official title: Comparison of Ultrasound-Guided Lateral and Medial Approaches to Costoclavicular Brachial Plexus Block 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
Costoclavicular Block
Brachial Plexus Block
Ultrasound Guidance
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 55
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. In this study, we aim to compare the different approaches of US guided costoclavicular technique. Lateral approache is more common for the costoclavicular block area. However, more needle maneuvers are needed especially in pediatric patients because of the coracoid process. Medial approach is recommended to overcome this problem. 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 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.

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. In this study, we aim to compare the different approaches of US guided costoclavicular technique. Lateral approache is more common for the costoclavicular block area. However, more needle maneuvers are needed especially in pediatric patients because of the coracoid process. Medial approach is recommended to overcome this problem. 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 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.

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: Number of needle maneuvers
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: Requirement of additional needle maneuver due to insufficient local anesthetic distribution
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: Time to first pain
timeFrame: Up to 24 hours
measure: Patient number requiring additional analgesix
timeFrame: Up to 24 hours
measure: Sleeping duration
timeFrame: Up to 24 hours
measure: Complications/side effects
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
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.