Comparison of Supraclavicular and Costoclavicular Brachial Plexus Blocks in Pediatrics

Sponsor

Istanbul University (Other)

Overall Status

Completed

CT.gov ID

NCT04782778

Collaborator

(none)

Enrollment

Location

Arms

15.4

Actual Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia, Local Postoperative Pain	Drug: Bupivacaine 0.25% Injectable Solution	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

58 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

RANDOMISED DOUBLE BLINDED INTERVENTIONALRANDOMISED DOUBLE BLINDED INTERVENTIONAL

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Screening

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

Actual Study Start Date :

Apr 1, 2021

Actual Primary Completion Date :

May 1, 2022

Actual Study Completion Date :

Jul 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Costoclavicular Block US-guided lateral approach costoclavicular block with 1 mg/kg Bupivacaine (%0,25)	Drug: Bupivacaine 0.25% Injectable Solution 1 mg/kg Bupivacaine (0.25%) Other Names: Marcaine
Active Comparator: Ultrasound Guided Supraclavicular Block US-guided supraclavicular block with 1 mg/kg Bupivacaine (%0,25)	Drug: Bupivacaine 0.25% Injectable Solution 1 mg/kg Bupivacaine (0.25%) Other Names: Marcaine

Arm

Intervention/Treatment

Active Comparator: Costoclavicular Block

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

Drug: Bupivacaine 0.25% Injectable Solution

1 mg/kg Bupivacaine (0.25%)

Other Names:

Marcaine

Active Comparator: Ultrasound Guided Supraclavicular Block

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

Drug: Bupivacaine 0.25% Injectable Solution

1 mg/kg Bupivacaine (0.25%)

Other Names:

Marcaine

Outcome Measures

Primary Outcome Measures

Total block application time [Up to 15 minutes]
Total block application time from the needle's entrance to the exit from the skin

Secondary Outcome Measures

Ideal USG guided brachial plexus cords visualization/needle pathway planning time [Up to 15 minutes]
Practitioner's ideal image acquisition time
Needle tip and shaft imaging visualization [Up to 15 minutes]
Likert scale: 1-5 (1:very hard 5:very easy)
Number of needle maneuvers [Up to 15 minutes]
Number of needle maneuvers according to local anesthetic distribution
Total procedure difficulty according to the anesthesiologist [Up to 15 minutes]
Likert Scale: 1-5 (1:very hard 5:very easy)
Patient number requiring rescue analgesics [Intraoperative 2-4 hours]
If a ≥ 20% increase above preinduction values in MAP or HR was observed during the perioperative period, additional fentanyl dose (1 μg/kg) was applied intravenously.
Face, Legs Activity, Cry, Consolability (FLACC) scores [Up to 24 hours]
It corporates five categories of behavior, each scored on 0-2 point scale so that total score ranges from 0 to 10. Total scores of 0-3 is defined as mild or no pain, 4-7 as moderate, and 8-10 as severe pain.
Wong Baker FACES scale [Up to 24 hours]
The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable"
Motor blockade physical examination [Up to 24 hours]
Each nerve scored on 0-2 point scale so that total score ranges from 0 to 8. Total scores of 0 point is defined as absent motor blockade (full movement); 1 point as partial blockade (able to free movement only) or 2 point as complete blockade (unable to move). (Separately for these four nerves; N. Medianus, N. ulnaris, N. radialis and N. musculocutaneous).
Sensorial blockade physical examination [Up to 24 hours]
Each nerve scored on 0-2 point scale with pinprick test so that total score ranges from 0 to 8. Total scores of 0 point is defined as absent sensorial blockade (feels pain), 1 point as partial blockade (feels touch) or 2 point as complete blockade (no sense). (Separately for these four nerves; N. Medianus, N. ulnaris, N. radialis and N. musculocutaneous).
Complications/side effects [Up to first week]
Vascular puncture, hematoma, pleura puncture, infections, phrenic nerve paralysis
Incidence of symptomatic/asymptomatic postprocedural phrenic nerve paralysis [Up to 2 hours]
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 end of inspiratory is recorded and the diaphragm thickness fraction is calculated.
Time to postoperative first pain [Up to 24 hours]
Time to first analgesic
Patient number who require additional analgesic [Up to 24 hours]
Number of patients who require IV morphine (0.03 mg/kg) and paracetamol
Duration of sleep [Up to 24 hours]
Total hours of sleep first day
Family satisfaction [Up to 24 hours]
Satisfaction score: 0: very unsatisfied, 3: very satisfied
Surgeon satisfaction [Up to 24 hours]
Satisfaction score: 0: very unsatisfied, 3: very satisfied