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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04764591
Other study ID # 2020/24-10
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date December 1, 2022

Study information

Verified date February 2024
Source Zonguldak Bulent Ecevit University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 1, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Intervention

Other:
Lateral sagittal approach
Lateral sagittal approach for ultrasound guided infraclavicular brachial plexus block
Costoclavicular approach
Costoclavicular approach for ultrasound guided infraclavicular brachial plexus block

Locations

Country Name City State
Turkey Zonguldak Bülent Ecevit University Medicine Faculty Zonguldak Kozlu

Sponsors (1)

Lead Sponsor Collaborator
Zonguldak Bulent Ecevit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary perfusion index the effect of the block on the perfusion index up to motor block scale =3
Primary tissue oxygenation the effect of the block on the tissue oxygenation up to motor block scale =3
Secondary motor block onset time quality of motor block scale =2 Assessed 40 minutes after block completion
Secondary sensorial block onset time quality of sensorial block scale =2 up to 24 hours
Secondary complications block related complications such as pneumothorax, vascular injury, local anesthetic systemic toxicity up to 24 hours
Secondary duration of block application from the needle puncture to the end of the local anesthetic injection during the intervention
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