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Completed

NCT Number: NCT02820688

Concentration-Volume Relationship in Infraclavicular Block

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Izmir Bozyaka Training and Research Hospital

Izmir, İzmir, 35170, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine 0.25%

Drug

Other names: Marcaine

prilocaine 1%

Drug

Other names: Citanest

Infraclavicular nerve block

Procedure

Ultrasound guided infraclavicular nerve block

Bupivacaine 0.167%

Drug

Other names: Marcaine

Bupivacaine 0.125%

Drug

Other names: Marcaine

Prilocaine 0.66%

Drug

Other names: Citanest

Prilocaine 0.5%

Drug

Other names: Citanest

Ultrasound

Device

All nerve blocks will be performed with ultrasound guidance

Primary outcomes

  1. Sensory Block, as assessed by hollman scale for pinprick test

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

    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.

  2. Motor Block, as assessed by hollman scale for motor blockade

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

    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.

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

    Time frame: 1th hour in PACU

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

    Time frame: 1th hour in PACU

Secondary outcomes

  1. Pain, as assessed by visual analogue scale

    Time frame: 1st hour and 6th hour

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

Sponsors and collaborators

Lead sponsor

Bozyaka Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 1, 2016
Registry last updated
Jan 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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