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Clinical Trials/NCT02820688
NCT02820688
Completed
Phase 4

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

Bozyaka Training and Research Hospital1 site in 1 country81 target enrollmentJune 2016

Overview

Phase
Phase 4
Intervention
Bupivacaine 0.25%
Conditions
Brachial Plexus Blockade
Sponsor
Bozyaka Training and Research Hospital
Enrollment
81
Locations
1
Primary Endpoint
Sensory Block, as assessed by hollman scale for pinprick test
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
October 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Bozyaka Training and Research Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

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

Intervention: Bupivacaine 0.25%

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

Intervention: Prilocaine 1%

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

Intervention: Infraclavicular Nerve Block

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

Intervention: Ultrasound

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

Intervention: Infraclavicular Nerve Block

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

Intervention: Bupivacaine 0.167%

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

Intervention: Prilocaine 0.66%

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

Intervention: Ultrasound

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

Intervention: Infraclavicular Nerve Block

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

Intervention: Bupivacaine 0.125%

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

Intervention: Prilocaine 0.5%

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

Intervention: Ultrasound

Outcomes

Primary Outcomes

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.

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.

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

Time Frame: 1th hour in PACU

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

Time Frame: 1th hour in PACU

Secondary Outcomes

  • Pain, as assessed by visual analogue scale(1st hour and 6th hour)

Study Sites (1)

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