Concentration-Volume Relationship in Infraclavicular Block

NCT02820688 | Completed Phase 4

• 1 other identifier: ANES-IK-0609
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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

Conditions

Brachial Plexus Blockade

Keywords

Local Anesthtetics; Nerve Block; Bupivacaine; Prilocaine

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Pain, as assessed by visual analogue scale

  1st hour and 6th hour

Study Arms (3)

Concentrated

ACTIVE COMPARATOR

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%; Drug: Prilocaine 1%; Procedure: Infraclavicular Nerve Block; Device: Ultrasound

Diluted by 33%

ACTIVE COMPARATOR

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; Drug: Bupivacaine 0.167%; Drug: Prilocaine 0.66%; Device: Ultrasound

Diluted by 50%

ACTIVE COMPARATOR

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; Drug: Bupivacaine 0.125%; Drug: Prilocaine 0.5%; Device: Ultrasound

Interventions

Bupivacaine 0.25% DRUG

Also known as: Marcaine

Concentrated

Prilocaine 1% DRUG

Also known as: Citanest

Concentrated

Infraclavicular Nerve Block PROCEDURE

Ultrasound guided infraclavicular nerve block

Concentrated; Diluted by 33%; Diluted by 50%

Bupivacaine 0.167% DRUG

Also known as: Marcaine

Diluted by 33%

Bupivacaine 0.125% DRUG

Also known as: Marcaine

Diluted by 50%

Prilocaine 0.66% DRUG

Also known as: Citanest

Diluted by 33%

Prilocaine 0.5% DRUG

Also known as: Citanest

Diluted by 50%

Ultrasound DEVICE

All nerve blocks will be performed with ultrasound guidance

Concentrated; Diluted by 33%; Diluted by 50%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for upper extremity surgery with infraclavicular nerve block

You may not qualify if:

• 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

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

Izmir Bozyaka Training and Research Hospital

Izmir, İzmir, 35170, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 26473102 BACKGROUND

• 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.

  PMID: 23518863 BACKGROUND

• 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.

  PMID: 26423050 BACKGROUND

MeSH Terms

Interventions

Bupivacaine; Prilocaine; Ultrasonography

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Zeki T Tekgul, MD

  Izmir Bozyaka Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: July 1, 2016
• Study Start: June 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: January 5, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)