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Concentration-Volume Relationship in Infraclavicular Block

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ClinicalTrials.gov Identifier: NCT02820688
Recruitment Status : Completed
First Posted : July 1, 2016
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):
Bozyaka Training and Research Hospital

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

Condition or disease Intervention/treatment Phase
Brachial Plexus Blockade Drug: Bupivacaine 0.25% Drug: Prilocaine 1% Procedure: Infraclavicular Nerve Block Drug: Bupivacaine 0.167% Drug: Bupivacaine 0.125% Drug: Prilocaine 0.66% Drug: Prilocaine 0.5% Device: Ultrasound Phase 4

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  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Local Anesthetic Concentration-Volume Modifications on Ultrasound Guided Infraclavicular Nerve Block Effectiveness
Study Start Date : June 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


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 Name: Marcaine

Drug: Prilocaine 1%
Other Name: 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

Drug: Bupivacaine 0.167%
Other Name: Marcaine

Drug: Prilocaine 0.66%
Other Name: Citanest

Device: Ultrasound
All nerve blocks will be performed with ultrasound guidance

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

Drug: Bupivacaine 0.125%
Other Name: Marcaine

Drug: Prilocaine 0.5%
Other Name: Citanest

Device: Ultrasound
All nerve blocks will be performed with ultrasound guidance




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Surgeries that are expected to last longer than 3 hours

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02820688


Locations
Turkey
Izmir Bozyaka Training and Research Hospital
Izmir, Turkey, 35170
Sponsors and Collaborators
Bozyaka Training and Research Hospital
Investigators
Principal Investigator: Zeki T Tekgul, MD Izmir Bozyaka Training and Research Hospital

Publications:
Responsible Party: Bozyaka Training and Research Hospital
ClinicalTrials.gov Identifier: NCT02820688     History of Changes
Other Study ID Numbers: ANES-IK-0609
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: January 5, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Bozyaka Training and Research Hospital:
Local Anesthtetics
Nerve Block
Bupivacaine
Prilocaine

Additional relevant MeSH terms:
Bupivacaine
Prilocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents