Concentration-Volume Relationship in Infraclavicular Block

Phase 4CompletedNCT02820688

Bozyaka Training and Research Hospital81 enrolled

Overview

This prospective, randomized, double blind study aims to determine the optimal volume for adequate sensorial and motor blockade following an infraclavicular block. Patients will be randomized into three groups. Using a constant dose of local anesthetics (45mg bupivacaine 180mg prilocaine), different volumes will be used in each of the groups (First group; 18mL, second group; 27mL, third group; 36mL). Onset, duration and quality of sensory and motor block will be compared for patients between groups

Although ultrasound guided infraclavicular nerve block is routinely used to provide anesthesia for almost all of the upper extremity surgeries, optimal volume and concentration of locak anesthetic to be administered is still a subject of debate. This prospective, randomized, double blind study aims to determine the optimal volume for adequate sensorial and motor blockade following an infraclavicular block. Patients will be randomly allocated into three groups. 81 patients (27 in each group) are planned to be enrolled in this study due to a power analysis performed (G-power ver 3.1). Using a constant dose of local anesthetics (45mg bupivacaine 180mg prilocaine), different volumes will be used in each of the groups (First group; 18mL, second group; 27mL, third group; 36mL). Onset, duration and quality of sensory and motor block will be compared for patients between groups Researchers who perform the block and assess the block quality and onset will be blinded to patients' groups. Patients will also be blinded to groups they are assigned.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Brachial Plexus Blockade

Interventions

Bupivacaine 0.25%DRUG

Prilocaine 1%DRUG

Infraclavicular Nerve BlockPROCEDURE

Ultrasound guided infraclavicular nerve block

Bupivacaine 0.167%

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Scheduled for upper extremity surgery with infraclavicular nerve block Exclusion Criteria: * Patient Refusal * Patients younger than 18 * Patients with known local anesthetic allergies * Patients with a BMI\>30 * Diabetic Patients * Uncooperated Patients * Patients with coagulopathy or recieving anticoagulant therapy * Skin infection on injection site * Patients diagnosed with sepsis or bacteremia * Physiologic and emotional lability * Surgeries that are expected to last longer than 3 hours

Locations (1)

Izmir Bozyaka Training and Research Hospital

Izmir, İzmir, Turkey (Türkiye)

Outcomes

Primary Outcomes

Sensory Block, as assessed by hollman scale for pinprick test

Sensorial response to pinprick will be assessed at innervation sites of ulnar median radial and musculocutaneous nerves. Innervation sites of assessment are volar skin of the fifth finger for ulnar nerve, volar skin of second finger for median nerve and dorsal, proximal of the second finger for radial nerve and skin of the anterolateral forearm for musculocutaneous nerve.

Time frame: 0, 3rd, 6th, 9th, 12th, 20th, 25th, 30th minute

Motor Block, as assessed by hollman scale for motor blockade

Motor function for each nerve will be assessed. Movements to be evaluated are; abduction of the fingers for ulnar nerve, thumb opposition for median nerve, extension of the forearm for radial nerve and flexion of the forearm for musculocutaneous nerve.

Time frame: 0, 3rd, 6th, 9th, 12th, 20th, 25th, 30th minute

Postoperative Sensory Block, as assessed by hollman scale for pinprick test

Time frame: 1th hour in PACU

Postoperative Motor Block, as assessed by hollman scale for motor blockadet

Time frame: 1th hour in PACU

Secondary Outcomes

Pain, as assessed by visual analogue scale

In addition, patients' first complaint time of pain will be recorded by nurse

Time frame: 1st hour and 6th hour

Data from ClinicalTrials.gov

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