NCT04782778

Comparison of Supraclavicular and Costoclavicular Brachial Plexus Blocks in Pediatrics

Completed NA Last updated 1 August 2022

What this trial tests

NA trial testing Bupivacaine 0.25% Injectable Solution in Anesthesia, Local in 58 participants. Completed in 15 July 2022.

Timeline

1 April 2021

Primary endpoint
1 May 2022

15 July 2022

Quick facts

Lead sponsor	Istanbul University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	screening
Enrollment	58
Start date	1 April 2021
Primary completion	1 May 2022
Estimated completion	15 July 2022
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Bupivacaine 0.25% Injectable Solution — full drug profile →

Conditions studied

• Anesthesia, Local — all drugs for Anesthesia, Local →
• Postoperative Pain — all drugs for Postoperative Pain →

Sponsor

Istanbul University

Who can join

Adults 2 to 10, any sex, with Anesthesia, Local or Postoperative Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.