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Concentration-Volume Relationship in Infraclavicular Block

Impact of Local Anesthetic Concentration-Volume Modifications on Ultrasound Guided Infraclavicular Nerve Block Effectiveness

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02820688
Enrollment
81
Registered
2016-07-01
Start date
2016-06-30
Completion date
2016-10-31
Last updated
2017-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brachial Plexus Blockade

Keywords

Local Anesthtetics, Nerve Block, Bupivacaine, Prilocaine

Brief summary

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

Detailed 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.

Interventions

DRUGBupivacaine 0.25%

Ultrasound guided infraclavicular nerve block

DRUGBupivacaine 0.167%
DRUGPrilocaine 0.66%
DRUGPrilocaine 0.5%
DEVICEUltrasound

All nerve blocks will be performed with ultrasound guidance

Sponsors

Bozyaka Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Sensory Block, as assessed by hollman scale for pinprick test0, 3rd, 6th, 9th, 12th, 20th, 25th, 30th minuteSensorial 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.
Motor Block, as assessed by hollman scale for motor blockade0, 3rd, 6th, 9th, 12th, 20th, 25th, 30th minuteMotor 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.
Postoperative Sensory Block, as assessed by hollman scale for pinprick test1th hour in PACU
Postoperative Motor Block, as assessed by hollman scale for motor blockadet1th hour in PACU

Secondary

MeasureTime frameDescription
Pain, as assessed by visual analogue scale1st hour and 6th hourIn addition, patients' first complaint time of pain will be recorded by nurse

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026