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

Sponsor
Istanbul University (Other)
Overall Status
Completed
CT.gov ID
NCT04786756
Collaborator
(none)
55
1
2
23.9
2.3

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. 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.

Condition or Disease Intervention/Treatment Phase
  • 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. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
55 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 Lateral and Medial Approaches to Costoclavicular Brachial Plexus Block in Pediatric Patients Undergoing Unilateral Upper Exremity Surgery: A Randomized Controlled Double-Blinded Study
Actual Study Start Date :
Jan 1, 2020
Actual Primary Completion Date :
Dec 25, 2021
Actual Study Completion Date :
Dec 27, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Lateral Approach of 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: Medial Approach of Costoclavicular Block

    US-guided medial 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
  • Outcome Measures

    Primary Outcome Measures

    1. Number of needle maneuvers [Up to 15 minutes]

      Number of needle maneuvers according to local anesthetic distribution

    Secondary Outcome Measures

    1. Ideal USG guided brachial plexus cords visualization/needle pathway planning time [Up to 15 minutes]

      Practitioner's ideal image acquisition time

    2. Needle tip and shaft imaging visualization [Up to 15 minutes]

      Likert scale: 1-5

    3. Requirement of additional needle maneuver due to insufficient local anesthetic distribution [Up to 15 minutes]

      Extra needle redirection to cover neural tissue

    4. Total procedure difficulty according to the anesthesiologist [Up to 15 minutes]

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

    5. 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.

    6. 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.

    7. 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"

    8. 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).

    9. 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).

    10. Time to first pain [Up to 24 hours]

      Time to first analgesic

    11. Patient number requiring additional analgesix [Up to 24 hours]

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

    12. Sleeping duration [Up to 24 hours]

      Total hours of sleep first day

    13. Complications/side effects [Up to 24 hours]

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

    14. Family satisfaction [Up to 24 hours]

      Satisfaction score: 0: very unsatisfied 3: very satisfied

    15. Surgeon satisfaction [Up to 24 hours]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 10 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Istanbul University Istanbul Turkey 34093

    Sponsors and Collaborators

    • Istanbul University

    Investigators

    • Principal Investigator: Meltem Savran Karadeniz, Assoc.Prof., Istanbul University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Meltem Savran Karadeniz, Associate Professor, Istanbul University
    ClinicalTrials.gov Identifier:
    NCT04786756
    Other Study ID Numbers:
    • 2019/1556
    First Posted:
    Mar 8, 2021
    Last Update Posted:
    Jan 11, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Meltem Savran Karadeniz, Associate Professor, Istanbul University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 11, 2022