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Comparison of Lateral and Medial Approaches to Costoclavicular Brachial Plexus Block in Pediatrics

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04786756
Enrollment
55
Registered
2021-03-08
Start date
2020-01-01
Completion date
2021-12-27
Last updated
2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Local, Postoperative Pain

Keywords

Postoperative Analgesia, Upper Extremity Surgery, Costoclavicular Block, Brachial Plexus Block, Ultrasound Guidance

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.

Interventions

1 mg/kg Bupivacaine (0.25%)

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

RANDOMISED DOUBLE BLINDED INTERVENTIONAL

Eligibility

Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of needle maneuversUp to 15 minutesNumber of needle maneuvers according to local anesthetic distribution

Secondary

MeasureTime frameDescription
Patient number requiring rescue analgesicsIntraoperative 2-4 hoursIf 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.
Ideal USG guided brachial plexus cords visualization/needle pathway planning timeUp to 15 minutesPractitioner's ideal image acquisition time
Needle tip and shaft imaging visualizationUp to 15 minutesLikert scale: 1-5
Requirement of additional needle maneuver due to insufficient local anesthetic distributionUp to 15 minutesExtra needle redirection to cover neural tissue
Face, Legs Activity, Cry, Consolability (FLACC) scoresUp to 24 hoursIt 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 scaleUp to 24 hoursThe 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 examinationUp to 24 hoursEach 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).
Total procedure difficulty according to the anesthesiologistUp to 15 minutesLikert Scale 1-5 (1:very hard 5:very easy)
Time to first painUp to 24 hoursTime to first analgesic
Patient number requiring additional analgesixUp to 24 hoursNumber of patients who require IV morphine (0.03 mg/kg) and paracetamol (15 mg/kg)
Sleeping durationUp to 24 hoursTotal hours of sleep first day
Complications/side effectsUp to 24 hoursPossible complications related to costoclavicular block (such as vascular puncture, hematoma, pneumothorax, diaphragma palsy...)
Family satisfactionUp to 24 hoursSatisfaction score: 0: very unsatisfied 3: very satisfied
Surgeon satisfactionUp to 24 hoursSatisfaction score: 0: very unsatisfied, 3: very satisfied
Sensorial blockade physical examinationUp to 24 hoursEach 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).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026