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Completed

NCT Number: NCT04786756

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

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.

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Key information

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University

Istanbul, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine 0.25% Injectable Solution

Drug

1 mg/kg Bupivacaine (0.25%)

Other names: Marcaine

Primary outcomes

  1. Number of needle maneuvers

    Time frame: Up to 15 minutes

    Number of needle maneuvers according to local anesthetic distribution

Secondary outcomes

  1. Ideal USG guided brachial plexus cords visualization/needle pathway planning time

    Time frame: Up to 15 minutes

    Practitioner's ideal image acquisition time

  2. Needle tip and shaft imaging visualization

    Time frame: Up to 15 minutes

    Likert scale: 1-5

  3. Requirement of additional needle maneuver due to insufficient local anesthetic distribution

    Time frame: Up to 15 minutes

    Extra needle redirection to cover neural tissue

  4. Total procedure difficulty according to the anesthesiologist

    Time frame: Up to 15 minutes

    Likert Scale 1-5 (1:very hard 5:very easy)

  5. Patient number requiring rescue analgesics

    Time frame: 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.

  6. Face, Legs Activity, Cry, Consolability (FLACC) scores

    Time frame: 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.

  7. Wong Baker FACES scale

    Time frame: 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"

  8. Motor blockade physical examination

    Time frame: 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).

  9. Sensorial blockade physical examination

    Time frame: 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).

  10. Time to first pain

    Time frame: Up to 24 hours

    Time to first analgesic

  11. Patient number requiring additional analgesix

    Time frame: Up to 24 hours

    Number of patients who require IV morphine (0.03 mg/kg) and paracetamol (15 mg/kg)

  12. Sleeping duration

    Time frame: Up to 24 hours

    Total hours of sleep first day

  13. Complications/side effects

    Time frame: Up to 24 hours

    Possible complications related to costoclavicular block (such as vascular puncture, hematoma, pneumothorax, diaphragma palsy...)

  14. Family satisfaction

    Time frame: Up to 24 hours

    Satisfaction score: 0: very unsatisfied 3: very satisfied

  15. Surgeon satisfaction

    Time frame: Up to 24 hours

    Satisfaction score: 0: very unsatisfied, 3: very satisfied

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 8, 2021
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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