Concentration-Volume Relationship in Infraclavicular Block

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

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

Study Overview

• Status: Completed
• Conditions: Brachial Plexus Blockade
• Intervention / Treatment: Drug: Bupivacaine 0.25%; Drug: Prilocaine 1%; Procedure: Infraclavicular Nerve Block; Device: Ultrasound; Drug: Bupivacaine 0.167%; Drug: Prilocaine 0.66%; Drug: Bupivacaine 0.125%; Drug: Prilocaine 0.5%

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.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey, 35170
    • Izmir Bozyaka Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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	Drug: Bupivacaine 0.25%; Other Names: Marcaine; Drug: Prilocaine 1%; Other Names: Citanest; Procedure: Infraclavicular Nerve Block; Ultrasound guided infraclavicular nerve block; Device: Ultrasound; All nerve blocks will be performed with ultrasound guidance
ACTIVE_COMPARATOR: 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	Procedure: Infraclavicular Nerve Block; Ultrasound guided infraclavicular nerve block; Device: Ultrasound; All nerve blocks will be performed with ultrasound guidance; Drug: Bupivacaine 0.167%; Other Names: Marcaine; Drug: Prilocaine 0.66%; Other Names: Citanest
ACTIVE_COMPARATOR: 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	Procedure: Infraclavicular Nerve Block; Ultrasound guided infraclavicular nerve block; Device: Ultrasound; All nerve blocks will be performed with ultrasound guidance; Drug: Bupivacaine 0.125%; Other Names: Marcaine; Drug: Prilocaine 0.5%; Other Names: Citanest

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	0, 3rd, 6th, 9th, 12th, 20th, 25th, 30th minute
Postoperative Sensory Block, as assessed by hollman scale for pinprick test		1th hour in PACU
Postoperative Motor Block, as assessed by hollman scale for motor blockadet		1th hour in PACU

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain, as assessed by visual analogue scale	In addition, patients' first complaint time of pain will be recorded by nurse	1st hour and 6th hour

Collaborators and Investigators

• Sponsor: Bozyaka Training and Research Hospital

Publications and helpful links

General Publications

• Mosaffa F, Gharaei B, Qoreishi M, Razavi S, Safari F, Fathi M, Mohseni G, Elyasi H, Hosseini F. Do the Concentration and Volume of Local Anesthetics Affect the Onset and Success of Infraclavicular Anesthesia? Anesth Pain Med. 2015 Aug 22;5(4):e23963. doi: 10.5812/aapm.23963v2. eCollection 2015 Aug.
• Gonzalez AP, Bernucci F, Techasuk W, Pham K, Finlayson RJ, Tran DQ. A randomized comparison between 3 combinations of volume and concentration of lidocaine for ultrasound-guided infraclavicular block. Reg Anesth Pain Med. 2013 May-Jun;38(3):206-11. doi: 10.1097/AAP.0b013e318287fe53.
• Fenten MG, Schoenmakers KP, Heesterbeek PJ, Scheffer GJ, Stienstra R. Effect of local anesthetic concentration, dose and volume on the duration of single-injection ultrasound-guided axillary brachial plexus block with mepivacaine: a randomized controlled trial. BMC Anesthesiol. 2015 Sep 30;15:130. doi: 10.1186/s12871-015-0110-0.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (ACTUAL): October 1, 2016
• Study Completion (ACTUAL): October 1, 2016

Study Registration Dates

• First Submitted: June 10, 2016
• First Submitted That Met QC Criteria: June 28, 2016
• First Posted (ESTIMATE): July 1, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): January 5, 2017
• Last Update Submitted That Met QC Criteria: January 4, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Nerve Block; Prilocaine; Bupivacaine; Local Anesthtetics
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Prilocaine; Bupivacaine
• Other Study ID Numbers: ANES-IK-0609

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO