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PI and Tissue Perfusion for Different Approaches of Brachial Plexus Block

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04764591
Recruitment Status : Completed
First Posted : February 21, 2021
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
Çağdaş Baytar, Zonguldak Bulent Ecevit University

Study Description
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Brief Summary:
To compare the two different approaches of infraclavicular brachial plexus block in forearm, wrist and hand surgery in terms of perfusion index, tissue oxygenation, sensory and motor block onset time and total effect time, first analgesic time, side effects and complications, and duration of block application.

Condition or disease Intervention/treatment Phase
Upper Extremity Fracture Regional Anesthesia Brachial Plexus Blocks Perfusion Index Tissue Perfusion Other: Lateral sagittal approach Other: Costoclavicular approach Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effect of Different Approaches of Infraclavicular Brachial Plexus Block on Perfusion Index and Tissue Perfusion: A Randomized Controlled Trial
Actual Study Start Date : December 16, 2020
Actual Primary Completion Date : August 1, 2021
Actual Study Completion Date : September 1, 2021
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Lateral sagittal approach
Patients in this group will be randomized to receive a lateral sagittal approach for Ultrasound Guided Infraclavicular Brachial Plexus Nerve Block .
 Other: Lateral sagittal approach
Lateral sagittal approach for ultrasound guided infraclavicular brachial plexus block
Active Comparator: Costoclavicular approach
Patients in this group will be randomized to receive a costoclavicular approach to Ultrasound Guided Infraclavicular Brachial Plexus Nerve Block .
 Other: Costoclavicular approach
Costoclavicular approach for ultrasound guided infraclavicular brachial plexus block


Outcome Measures
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Primary Outcome Measures :
  1. perfusion index [ Time Frame: up to motor block scale ≥3 ]
    the effect of the block on the perfusion index

  2. tissue oxygenation [ Time Frame: up to motor block scale ≥3 ]
    the effect of the block on the tissue oxygenation


Secondary Outcome Measures :
  1. motor block onset time [ Time Frame: Assessed 40 minutes after block completion ]
    quality of motor block scale ≥2

  2. sensorial block onset time [ Time Frame: up to 24 hours ]
    quality of sensorial block scale ≥2

  3. complications [ Time Frame: up to 24 hours ]
    block related complications such as pneumothorax, vascular injury, local anesthetic systemic toxicity

  4. duration of block application [ Time Frame: during the intervention ]
    from the needle puncture to the end of the local anesthetic injection


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients who undergo elective forearm or hand surgery under infraclavicular brachial plexus block
  • American Society of Anesthesiologists class 1 to 3
  • Ability to consent

Exclusion Criteria:

  • History of allergic reaction to local anaesthetics
  • Peripheral neuropathy
  • Renal or hepatic insufficiency
  • Coagulation disorders
Contacts and Locations
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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): NCT04764591


Locations
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Turkey
Zonguldak Bülent Ecevit University Medicine Faculty
Zonguldak, Kozlu, Turkey, 67600
Sponsors and Collaborators
Zonguldak Bulent Ecevit University
More Information
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Responsible Party: Çağdaş Baytar, assistant professor dr, Zonguldak Bulent Ecevit University
ClinicalTrials.gov Identifier: NCT04764591    
Other Study ID Numbers: 2020/24-10
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Çağdaş Baytar, Zonguldak Bulent Ecevit University:
lateral sagittal approach
costoclavicular approach
block success
perfusion index
brachial plexus