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Clinical Trials/NCT04782778
NCT04782778
Completed
Not Applicable

Comparison of Ultrasound-Guided Supraclavicular and Costoclavicular Brachial Plexus Blocks in Pediatric Patients Undergoing Unilateral Upper Exremity Surgery: A Randomized Controlled Double-Blinded Study

Istanbul University1 site in 1 country58 target enrollmentApril 1, 2021

Overview

Phase
Not Applicable
Intervention
Bupivacaine 0.25% Injectable Solution
Conditions
Anesthesia, Local
Sponsor
Istanbul University
Enrollment
58
Locations
1
Primary Endpoint
Total block application time
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2021
End Date
July 15, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Meltem Savran Karadeniz

Associate Professor

Istanbul University

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

Arms & Interventions

Costoclavicular Block

US-guided lateral approach costoclavicular block with 1 mg/kg Bupivacaine (%0,25)

Intervention: Bupivacaine 0.25% Injectable Solution

Ultrasound Guided Supraclavicular Block

US-guided supraclavicular block with 1 mg/kg Bupivacaine (%0,25)

Intervention: Bupivacaine 0.25% Injectable Solution

Outcomes

Primary Outcomes

Total block application time

Time Frame: Up to 15 minutes

Total block application time from the needle's entrance to the exit from the skin

Secondary Outcomes

  • Motor blockade physical examination(Up to 24 hours)
  • Patient number who require additional analgesic(Up to 24 hours)
  • Ideal USG guided brachial plexus cords visualization/needle pathway planning time(Up to 15 minutes)
  • Needle tip and shaft imaging visualization(Up to 15 minutes)
  • Number of needle maneuvers(Up to 15 minutes)
  • Total procedure difficulty according to the anesthesiologist(Up to 15 minutes)
  • Patient number requiring rescue analgesics(Intraoperative 2-4 hours)
  • Wong Baker FACES scale(Up to 24 hours)
  • Sensorial blockade physical examination(Up to 24 hours)
  • Complications/side effects(Up to first week)
  • Incidence of symptomatic/asymptomatic postprocedural phrenic nerve paralysis(Up to 2 hours)
  • Time to postoperative first pain(Up to 24 hours)
  • Family satisfaction(Up to 24 hours)
  • Surgeon satisfaction(Up to 24 hours)
  • Face, Legs Activity, Cry, Consolability (FLACC) scores(Up to 24 hours)
  • Duration of sleep(Up to 24 hours)

Study Sites (1)

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