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Comparison of Supraclavicular and Costoclavicular Brachial Plexus Blocks in Pediatrics

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ClinicalTrials.gov Identifier: NCT04782778
Recruitment Status : Recruiting
First Posted : March 4, 2021
Last Update Posted : March 4, 2021
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.

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 imaging by M-mode ultrasonography 30 minutes after extubation. 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 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.

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.

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 imaging by M-mode ultrasonography 30 minutes after extubation. Absence of diaphragmatic excursion during a sniff test or sighing defined the hemidiaphragmatic paralysis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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 Supraclavicular and Costoclavicular Brachial Plexus Blocks in Pediatric Patients Undergoing Unilateral Upper Exremity Surgery: A Randomized Controlled Double-Blinded Study
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Marcaine




Primary Outcome Measures :
  1. Total block application time [ Time Frame: Up to 15 minutes ]
    Total block application time from the needle's entrance to the exit from the skin


Secondary Outcome Measures :
  1. Ideal USG image acquisition time [ Time Frame: Up to 15 minutes ]
    Practitioner's ideal image acquisition time

  2. Needle tip imaging difficulty [ Time Frame: Up to 15 minutes ]
    Likert scale: 1-5

  3. Number of needle maneuvers [ Time Frame: Up to 15 minutes ]
    Number of needle maneuvers according to local anesthetic distribution

  4. The degree of strain of the practitioner [ Time Frame: Up to 15 minutes ]
    Scale 1-5 (1: very hard; 5: very easy)

  5. Number of patients required fentanyl intraoperatively [ 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 24hours. ]
    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. Motor blockade 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).

  8. Sensorial blockade 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).

  9. Incidence of complications and side effects [ Time Frame: Up to first week ]
    Vascular puncture, hematoma, pleura puncture, infections, phrenic nerve paralysis

  10. Incidence of symptomatic/asymptomatic postprocedural phrenic nerve paralysis [ Time Frame: Up to 2 hours ]
    Diaphragmatic excursion is imaging by M-mode ultrasonography 30 minutes after extubation

  11. Time until postoperative first pain [ Time Frame: Up to 24 hours ]
    Time to complain first pain

  12. Time to first analgesic [ Time Frame: Up to 24 hours ]
    Duration of postoperative analgesia

  13. Number of patients who require rescue analgesic [ Time Frame: Up to 24 hours ]
    Number of patients who require IV morphine (0.03 mg/kg) at the first two hours and paracetamol in the 24 hours

  14. Duration of sleep [ Time Frame: Up to 24 hours ]
    Total hours of sleep first day

  15. Patient satisfaction [ Time Frame: Up to 24 hours ]
    Satisfaction score: 0: very unsatisfied, 3: very satisfied

  16. Surgeon satisfaction [ Time Frame: Up to 24 hours ]
    Satisfaction score: 0: very unsatisfied, 3: very satisfied



Information from the National Library of Medicine

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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): NCT04782778


Contacts
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Contact: Mehmet Güzel, MD +905347113443 mehmet.guzel@istanbul.edu.tr
Contact: Meltem Savran Karadeniz, Assoc.Prof. +905334845563 mskaradeniz@gmail.com

Locations
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Turkey
Istanbul University Recruiting
Istanbul, Fatih, Turkey, 34093
Contact: Mehmet Güzel, MD    +905347113443    mehmet.guzel@istanbul.edu.tr   
Contact: Meltem Savran Karadeniz, Assoc.Prof.    +905334845563    mskaradeniz@gmail.com   
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: NCT04782778    
Other Study ID Numbers: 2020/46
First Posted: March 4, 2021    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021

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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
Supraclavicular Block
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