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

Not Applicable
Completed
Conditions
Postoperative Pain
Anesthesia, Local
Interventions
Registration Number
NCT04786756
Lead Sponsor
Istanbul University
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
55
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Medial Approach of Costoclavicular BlockBupivacaine 0.25% Injectable SolutionUS-guided medial approach costoclavicular block with 1 mg/kg Bupivacaine (%0,25)
Lateral Approach of Costoclavicular BlockBupivacaine 0.25% Injectable SolutionUS-guided lateral approach costoclavicular block with 1 mg/kg Bupivacaine (%0,25)
Primary Outcome Measures
NameTimeMethod
Number of needle maneuversUp to 15 minutes

Number of needle maneuvers according to local anesthetic distribution

Secondary Outcome Measures
NameTimeMethod
Face, Legs Activity, Cry, Consolability (FLACC) scoresUp to 24 hours

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 scaleUp to 24 hours

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"

Patient number requiring additional analgesixUp to 24 hours

Number of patients who require IV morphine (0.03 mg/kg) and paracetamol (15 mg/kg)

Sleeping durationUp to 24 hours

Total hours of sleep first day

Family satisfactionUp to 24 hours

Satisfaction score: 0: very unsatisfied 3: very satisfied

Total procedure difficulty according to the anesthesiologistUp to 15 minutes

Likert Scale 1-5 (1:very hard 5:very easy)

Motor blockade physical examinationUp to 24 hours

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 examinationUp to 24 hours

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 to first painUp to 24 hours

Time to first analgesic

Surgeon satisfactionUp to 24 hours

Satisfaction score: 0: very unsatisfied, 3: very satisfied

Ideal USG guided brachial plexus cords visualization/needle pathway planning timeUp to 15 minutes

Practitioner's ideal image acquisition time

Needle tip and shaft imaging visualizationUp to 15 minutes

Likert scale: 1-5

Requirement of additional needle maneuver due to insufficient local anesthetic distributionUp to 15 minutes

Extra needle redirection to cover neural tissue

Patient number requiring rescue analgesicsIntraoperative 2-4 hours

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.

Complications/side effectsUp to 24 hours

Possible complications related to costoclavicular block (such as vascular puncture, hematoma, pneumothorax, diaphragma palsy...)

Trial Locations

Locations (1)

Istanbul University

🇹🇷

Istanbul, Turkey

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