Comparison of Supraclavicular and Costoclavicular Brachial Plexus Blocks in Pediatrics

NCT04782778 | Completed

• 1 other identifier: 2020/46
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, Local; Postoperative Pain

Keywords

Postoperative Analgesia; Upper Extremity Surgery; Supraclavicular Block; Costoclavicular Block; Brachial Plexus Block; Ultrasound Guidance

Outcome Measures

Primary Outcomes (1)

• Total block application time

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

  Up to 15 minutes

Secondary Outcomes (16)

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

  Up to 15 minutes

• Needle tip and shaft imaging visualization

  Up to 15 minutes

• Number of needle maneuvers

  Up to 15 minutes

• Total procedure difficulty according to the anesthesiologist

  Up to 15 minutes

• Patient number requiring rescue analgesics

  Intraoperative 2-4 hours

Study Arms (2)

Costoclavicular Block

ACTIVE COMPARATOR

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

Drug: Bupivacaine 0.25% Injectable Solution

Ultrasound Guided Supraclavicular Block

ACTIVE COMPARATOR

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

Drug: Bupivacaine 0.25% Injectable Solution

Interventions

Bupivacaine 0.25% Injectable Solution DRUG

1 mg/kg Bupivacaine (0.25%)

Also known as: Marcaine

Costoclavicular Block; Ultrasound Guided Supraclavicular Block

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 29923950 BACKGROUND

• 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.

  PMID: 30857608 BACKGROUND

• 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.

  PMID: 31397702 BACKGROUND

• 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.

  PMID: 32441302 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Meltem Savran Karadeniz, Assoc.Prof.

  Istanbul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: RANDOMISED DOUBLE BLINDED INTERVENTIONAL

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 4, 2021
• Study Start: April 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: July 15, 2022
• Last Updated: August 1, 2022

Record last verified: 2022-07

Locations

TU (1)