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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04786756
• Other study ID #: 2019/1556
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 27, 2021

Study information

• Verified date: January 2022
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 27, 2021
• Est. primary completion date: December 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Local
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Bupivacaine 0.25% Injectable Solution
1 mg/kg Bupivacaine (0.25%)

Locations

Country	Name	City	State
Turkey	Istanbul University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of needle maneuvers	Number of needle maneuvers according to local anesthetic distribution	Up to 15 minutes
Secondary	Ideal USG guided brachial plexus cords visualization/needle pathway planning time	Practitioner's ideal image acquisition time	Up to 15 minutes
Secondary	Needle tip and shaft imaging visualization	Likert scale: 1-5	Up to 15 minutes
Secondary	Requirement of additional needle maneuver due to insufficient local anesthetic distribution	Extra needle redirection to cover neural tissue	Up to 15 minutes
Secondary	Total procedure difficulty according to the anesthesiologist	Likert Scale 1-5 (1:very hard 5:very easy)	Up to 15 minutes
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Time to first pain	Time to first analgesic	Up to 24 hours
Secondary	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
Secondary	Sleeping duration	Total hours of sleep first day	Up to 24 hours
Secondary	Complications/side effects	Possible complications related to costoclavicular block (such as vascular puncture, hematoma, pneumothorax, diaphragma palsy...)	Up to 24 hours
Secondary	Family satisfaction	Satisfaction score: 0: very unsatisfied 3: very satisfied	Up to 24 hours
Secondary	Surgeon satisfaction	Satisfaction score: 0: very unsatisfied, 3: very satisfied	Up to 24 hours