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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Anesthesia, Local
• Intervention / Treatment: Drug: Bupivacaine 0.25% Injectable Solution

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.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34093
    • Istanbul University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of needle maneuvers	Number of needle maneuvers according to local anesthetic distribution	Up to 15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ideal USG guided brachial plexus cords visualization/needle pathway planning time	Practitioner's ideal image acquisition time	Up to 15 minutes
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.	Intraoperative 2-4 hours
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.	Up to 24 hours
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"	Up to 24 hours
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).	Up to 24 hours
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).	Up to 24 hours
Surgeon satisfaction	Satisfaction score: 0: very unsatisfied, 3: very satisfied	Up to 24 hours
Needle tip and shaft imaging visualization	Likert scale: 1-5	Up to 15 minutes
Requirement of additional needle maneuver due to insufficient local anesthetic distribution	Extra needle redirection to cover neural tissue	Up to 15 minutes
Total procedure difficulty according to the anesthesiologist	Likert Scale 1-5 (1:very hard 5:very easy)	Up to 15 minutes
Time to first pain	Time to first analgesic	Up to 24 hours
Patient number requiring additional analgesix	Number of patients who require IV morphine (0.03 mg/kg) and paracetamol (15 mg/kg)	Up to 24 hours
Sleeping duration	Total hours of sleep first day	Up to 24 hours
Complications/side effects	Possible complications related to costoclavicular block (such as vascular puncture, hematoma, pneumothorax, diaphragma palsy...)	Up to 24 hours
Family satisfaction	Satisfaction score: 0: very unsatisfied 3: very satisfied	Up to 24 hours

Collaborators and Investigators

• Sponsor: Istanbul University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): December 25, 2021
• Study Completion (Actual): December 27, 2021

Study Registration Dates

• First Submitted: March 5, 2021
• First Submitted That Met QC Criteria: March 5, 2021
• First Posted (Actual): March 8, 2021

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Brachial Plexus Block; Postoperative Analgesia; Ultrasound Guidance; Upper Extremity Surgery; Costoclavicular Block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 2019/1556

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No