Concentration-Volume Relationship in Infraclavicular Block

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-10-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Brachial Plexus Blockade

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Concentrated

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

Group Type ACTIVE_COMPARATOR

Bupivacaine 0.25%

Intervention Type DRUG

Prilocaine 1%

Intervention Type DRUG

Infraclavicular Nerve Block

Intervention Type PROCEDURE

Ultrasound guided infraclavicular nerve block

Ultrasound

Intervention Type DEVICE

All nerve blocks will be performed with ultrasound guidance

Diluted by 33%

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

Group Type ACTIVE_COMPARATOR

Infraclavicular Nerve Block

Intervention Type PROCEDURE

Ultrasound guided infraclavicular nerve block

Bupivacaine 0.167%

Intervention Type DRUG

Prilocaine 0.66%

Intervention Type DRUG

Ultrasound

Intervention Type DEVICE

All nerve blocks will be performed with ultrasound guidance

Diluted by 50%

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

Group Type ACTIVE_COMPARATOR

Infraclavicular Nerve Block

Intervention Type PROCEDURE

Ultrasound guided infraclavicular nerve block

Bupivacaine 0.125%

Intervention Type DRUG

Prilocaine 0.5%

Intervention Type DRUG

Ultrasound

Intervention Type DEVICE

All nerve blocks will be performed with ultrasound guidance

Interventions

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Bupivacaine 0.25%

Intervention Type DRUG

Prilocaine 1%

Intervention Type DRUG

Infraclavicular Nerve Block

Ultrasound guided infraclavicular nerve block

Intervention Type PROCEDURE

Bupivacaine 0.167%

Intervention Type DRUG

Bupivacaine 0.125%

Intervention Type DRUG

Prilocaine 0.66%

Intervention Type DRUG

Prilocaine 0.5%

Intervention Type DRUG

Ultrasound

All nerve blocks will be performed with ultrasound guidance

Intervention Type DEVICE

Other Intervention Names

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Marcaine Citanest Marcaine Marcaine Citanest Citanest

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No