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

NCT04786756 | Completed

• 1 other identifier: 2019/1556
• Study Type: interventional
• Target: 55
• 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. 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.

Conditions

Anesthesia, Local; Postoperative Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of needle maneuvers

  Number of needle maneuvers according to local anesthetic distribution

  Up to 15 minutes

Secondary Outcomes (15)

• 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

• Requirement of additional needle maneuver due to insufficient local anesthetic distribution

  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)

Lateral Approach of Costoclavicular Block

ACTIVE COMPARATOR

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

Drug: Bupivacaine 0.25% Injectable Solution

Medial Approach of Costoclavicular Block

ACTIVE COMPARATOR

US-guided medial approach costoclavicular 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

Lateral Approach of Costoclavicular Block; Medial Approach of Costoclavicular 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, 34093, Turkey (Türkiye)

Location

Related Publications (1)

• 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

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 5, 2021
• First Posted: March 8, 2021
• Study Start: January 1, 2020
• Primary Completion: December 25, 2021
• Study Completion: December 27, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

TU (1)