search
Back to results

Comparison of Supraclavicular and Costoclavicular Brachial Plexus Blocks in Pediatrics

Primary Purpose

Anesthesia, Local, Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bupivacaine 0.25% Injectable Solution
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Anesthesia, Local focused on measuring Postoperative Analgesia, Upper Extremity Surgery, Supraclavicular Block, Costoclavicular Block, Brachial Plexus Block, Ultrasound Guidance

Eligibility Criteria

2 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Istanbul University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Costoclavicular Block

Ultrasound Guided Supraclavicular Block

Arm Description

US-guided lateral approach costoclavicular block with 1 mg/kg Bupivacaine (%0,25)

US-guided supraclavicular block with 1 mg/kg Bupivacaine (%0,25)

Outcomes

Primary Outcome Measures

Total block application time
Total block application time from the needle's entrance to the exit from the skin

Secondary Outcome Measures

Ideal USG guided brachial plexus cords visualization/needle pathway planning time
Practitioner's ideal image acquisition time
Needle tip and shaft imaging visualization
Likert scale: 1-5 (1:very hard 5:very easy)
Number of needle maneuvers
Number of needle maneuvers according to local anesthetic distribution
Total procedure difficulty according to the anesthesiologist
Likert Scale: 1-5 (1:very hard 5:very easy)
Patient number requiring rescue analgesics
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.
Face, Legs Activity, Cry, Consolability (FLACC) scores
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.
Wong Baker FACES scale
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"
Motor blockade physical examination
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).
Sensorial blockade physical examination
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).
Complications/side effects
Vascular puncture, hematoma, pleura puncture, infections, phrenic nerve paralysis
Incidence of symptomatic/asymptomatic postprocedural phrenic nerve paralysis
Diaphragmatic excursion is visualized by M-mode ultrasonography 30 minutes after extubation. In B-mode, the diaphragm thickness measurement at the end of expiratory and end of inspiratory is recorded and the diaphragm thickness fraction is calculated.
Time to postoperative first pain
Time to first analgesic
Patient number who require additional analgesic
Number of patients who require IV morphine (0.03 mg/kg) and paracetamol
Duration of sleep
Total hours of sleep first day
Family satisfaction
Satisfaction score: 0: very unsatisfied, 3: very satisfied
Surgeon satisfaction
Satisfaction score: 0: very unsatisfied, 3: very satisfied

Full Information

First Posted
March 2, 2021
Last Updated
July 29, 2022
Sponsor
Istanbul University
search

1. Study Identification

Unique Protocol Identification Number
NCT04782778
Brief Title
Comparison of Supraclavicular and Costoclavicular Brachial Plexus Blocks in Pediatrics
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
July 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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. 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 visualized by M-mode ultrasonography 30 minutes after extubation. In B-mode, the diaphragm thickness measurement at the end of expiratory and inspiratory end is recorded and the diaphragm thickness fraction is calculated. Absence of diaphragmatic excursion during a sniff test or sighing defined the hemidiaphragmatic paralysis.
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 visualized by M-mode ultrasonography 30 minutes after extubation. In B-mode, the diaphragm thickness measurement at the end of expiratory and inspiratory end is recorded and the diaphragm thickness fraction is calculated. Absence of diaphragmatic excursion during a sniff test or sighing defined the hemidiaphragmatic paralysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Local, Postoperative Pain
Keywords
Postoperative Analgesia, Upper Extremity Surgery, Supraclavicular Block, Costoclavicular Block, Brachial Plexus Block, Ultrasound Guidance

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RANDOMISED DOUBLE BLINDED INTERVENTIONAL
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Costoclavicular Block
Arm Type
Active Comparator
Arm Description
US-guided lateral approach costoclavicular block with 1 mg/kg Bupivacaine (%0,25)
Arm Title
Ultrasound Guided Supraclavicular Block
Arm Type
Active Comparator
Arm Description
US-guided supraclavicular block with 1 mg/kg Bupivacaine (%0,25)
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.25% Injectable Solution
Other Intervention Name(s)
Marcaine
Intervention Description
1 mg/kg Bupivacaine (0.25%)
Primary Outcome Measure Information:
Title
Total block application time
Description
Total block application time from the needle's entrance to the exit from the skin
Time Frame
Up to 15 minutes
Secondary Outcome Measure Information:
Title
Ideal USG guided brachial plexus cords visualization/needle pathway planning time
Description
Practitioner's ideal image acquisition time
Time Frame
Up to 15 minutes
Title
Needle tip and shaft imaging visualization
Description
Likert scale: 1-5 (1:very hard 5:very easy)
Time Frame
Up to 15 minutes
Title
Number of needle maneuvers
Description
Number of needle maneuvers according to local anesthetic distribution
Time Frame
Up to 15 minutes
Title
Total procedure difficulty according to the anesthesiologist
Description
Likert Scale: 1-5 (1:very hard 5:very easy)
Time Frame
Up to 15 minutes
Title
Patient number requiring rescue analgesics
Description
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.
Time Frame
Intraoperative 2-4 hours
Title
Face, Legs Activity, Cry, Consolability (FLACC) scores
Description
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.
Time Frame
Up to 24 hours
Title
Wong Baker FACES scale
Description
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"
Time Frame
Up to 24 hours
Title
Motor blockade physical examination
Description
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).
Time Frame
Up to 24 hours
Title
Sensorial blockade physical examination
Description
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).
Time Frame
Up to 24 hours
Title
Complications/side effects
Description
Vascular puncture, hematoma, pleura puncture, infections, phrenic nerve paralysis
Time Frame
Up to first week
Title
Incidence of symptomatic/asymptomatic postprocedural phrenic nerve paralysis
Description
Diaphragmatic excursion is visualized by M-mode ultrasonography 30 minutes after extubation. In B-mode, the diaphragm thickness measurement at the end of expiratory and end of inspiratory is recorded and the diaphragm thickness fraction is calculated.
Time Frame
Up to 2 hours
Title
Time to postoperative first pain
Description
Time to first analgesic
Time Frame
Up to 24 hours
Title
Patient number who require additional analgesic
Description
Number of patients who require IV morphine (0.03 mg/kg) and paracetamol
Time Frame
Up to 24 hours
Title
Duration of sleep
Description
Total hours of sleep first day
Time Frame
Up to 24 hours
Title
Family satisfaction
Description
Satisfaction score: 0: very unsatisfied, 3: very satisfied
Time Frame
Up to 24 hours
Title
Surgeon satisfaction
Description
Satisfaction score: 0: very unsatisfied, 3: very satisfied
Time Frame
Up to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meltem Savran Karadeniz, Assoc.Prof.
Organizational Affiliation
Istanbul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
29923950
Citation
Songthamwat B, Karmakar MK, Li JW, Samy W, Mok LYH. Ultrasound-Guided Infraclavicular Brachial Plexus Block: Prospective Randomized Comparison of the Lateral Sagittal and Costoclavicular Approach. Reg Anesth Pain Med. 2018 Nov;43(8):825-831. doi: 10.1097/AAP.0000000000000822.
Results Reference
background
PubMed Identifier
30857608
Citation
Grape S, Pawa A, Weber E, Albrecht E. Retroclavicular vs supraclavicular brachial plexus block for distal upper limb surgery: a randomised, controlled, single-blinded trial. Br J Anaesth. 2019 Apr;122(4):518-524. doi: 10.1016/j.bja.2018.12.022. Epub 2019 Jan 31.
Results Reference
background
PubMed Identifier
31397702
Citation
Sivashanmugam T, Maurya I, Kumar N, Karmakar MK. Ipsilateral hemidiaphragmatic paresis after a supraclavicular and costoclavicular brachial plexus block: A randomised observer blinded study. Eur J Anaesthesiol. 2019 Oct;36(10):787-795. doi: 10.1097/EJA.0000000000001069.
Results Reference
background
PubMed Identifier
32441302
Citation
Luo Q, Yao W, Chai Y, Chang L, Yao H, Liang J, Hao N, Guo S, Shu H. Comparison of ultrasound-guided supraclavicular and costoclavicular brachial plexus block using a modified double-injection technique: a randomized non-inferiority trial. Biosci Rep. 2020 Jun 26;40(6):BSR20200084. doi: 10.1042/BSR20200084.
Results Reference
background

Learn more about this trial

Comparison of Supraclavicular and Costoclavicular Brachial Plexus Blocks in Pediatrics

We'll reach out to this number within 24 hrs