Concentration-Volume Relationship in Infraclavicular Block

Bozyaka Training and Research Hospital

Status and phase: Completed; Phase 4

Conditions: Brachial Plexus Blockade

Treatments: Drug: Prilocaine 0.5%; Drug: Prilocaine 0.66%; Device: Ultrasound; Drug: Bupivacaine 0.25%; Drug: Bupivacaine 0.125%; Procedure: Infraclavicular Nerve Block; Drug: Prilocaine 1%; Drug: Bupivacaine 0.167%

Study type: Interventional

Funder types: Other

Identifiers

NCT02820688

ANES-IK-0609

Details and patient eligibility

About

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

Full description

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.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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81 participants in 3 patient groups

Concentrated

Active Comparator group

Description:

Infraclavicular nerve block under guidance of ultrasonography will be performed using an undiluted solution of 45mg bupivacaine and 180mg prilocaine (bupivacaine 0.25% and prilocaine 1%, 18mL in total) to patients in this group

Treatment:

Device: Ultrasound

Drug: Prilocaine 1%

Drug: Bupivacaine 0.25%

Procedure: Infraclavicular Nerve Block

Diluted by 33%

Active Comparator group

Description:

Infraclavicular nerve block under guidance of ultrasonography will be performed using a solution of 45mg bupivacaine and 180mg prilocaine diluted by 33% (bupivacaine 0.167% and prilocaine 0.66%, 27mL in total) to patients in this group

Treatment:

Device: Ultrasound

Drug: Bupivacaine 0.167%

Drug: Prilocaine 0.66%

Procedure: Infraclavicular Nerve Block

Diluted by 50%

Active Comparator group

Description:

Infraclavicular nerve block under guidance of ultrasonography will be performed using a solution of 45mg bupivacaine and 180mg prilocaine diluted by 50% (bupivacaine 0.125% and prilocaine 0.5%, 36mL in total) to patients in this group

Treatment:

Device: Ultrasound

Drug: Bupivacaine 0.125%

Procedure: Infraclavicular Nerve Block

Drug: Prilocaine 0.5%