Comparison of Supraclavicular and Costoclavicular Brachial Plexus Blocks in Pediatrics

Comparison of Ultrasound-Guided Supraclavicular and Costoclavicular Brachial Plexus Blocks 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.

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.

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.

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, 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
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total block application time	Total block application time from the needle's entrance to the exit from the skin	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
Needle tip and shaft imaging visualization	Likert scale: 1-5 (1:very hard 5:very easy)	Up to 15 minutes
Number of needle maneuvers	Number of needle maneuvers according to local anesthetic distribution	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
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
Complications/side effects	Vascular puncture, hematoma, pleura puncture, infections, phrenic nerve paralysis	Up to first week
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.	Up to 2 hours
Time to postoperative first pain	Time to first analgesic	Up to 24 hours
Patient number who require additional analgesic	Number of patients who require IV morphine (0.03 mg/kg) and paracetamol	Up to 24 hours
Duration of sleep	Total hours of sleep first day	Up to 24 hours
Family satisfaction	Satisfaction score: 0: very unsatisfied, 3: very satisfied	Up to 24 hours
Surgeon 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2021
• Primary Completion (ACTUAL): May 1, 2022
• Study Completion (ACTUAL): July 15, 2022

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (ACTUAL): March 4, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 29, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Brachial Plexus Block; Postoperative Analgesia; Supraclavicular Block; 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: 2020/46

Drug and device information, study documents

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