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

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ClinicalTrials.gov Identifier: NCT04786756
Recruitment Status : Completed
First Posted : March 8, 2021
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Meltem Savran Karadeniz, Istanbul University

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
Anesthesia, Local Postoperative Pain Drug: Bupivacaine 0.25% Injectable Solution Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RANDOMISED 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 : January 1, 2020
Actual Primary Completion Date : December 25, 2021
Actual Study Completion Date : December 27, 2021

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Marcaine




Primary Outcome Measures :
  1. Number of needle maneuvers [ Time Frame: 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 [ 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



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Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04786756


Locations
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Turkey
Istanbul University
Istanbul, Turkey, 34093
Sponsors and Collaborators
Istanbul University
Investigators
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Principal Investigator: Meltem Savran Karadeniz, Assoc.Prof. Istanbul University
Publications:
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Responsible Party: Meltem Savran Karadeniz, Associate Professor, Istanbul University
ClinicalTrials.gov Identifier: NCT04786756    
Other Study ID Numbers: 2019/1556
First Posted: March 8, 2021    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meltem Savran Karadeniz, Istanbul University:
Postoperative Analgesia
Upper Extremity Surgery
Costoclavicular Block
Brachial Plexus Block
Ultrasound Guidance
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents