Clinical trial NCT06416111: Comparison of Infraclavicular Brachial Plexus Block and Local Anesthesia in Arteriovenous Fistula Surgeries and Their Effects on Tissue Oxygen Saturation
Official title: Comparison of Infraclavicular Brachial Plexus Block and Local Anesthesia in Arteriovenous Fistula Surgeries and Their Effects on Tissue Oxygen Saturation With Near-infrared Spectroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Disease, Chronic
Keywords: arteriovenous fistula operation
Infraclavicular nerve block
Near-infrared spectroscopy (NIRS)
local anesthesia
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: NIRS probes will be placed on the thenar, antecubital regions of both hands and arms .The preoperative observed values and data of every 5 minutes during the operation will be recorded.
Primary purpose: OTHER

Brief summary: In arteriovenous fistula surgery, the effect of infraclavicular brachial plexus block and local anesthesia on tissue oxygenation and the effect of primary patency of the AV fistula is intended to research.

Detailed description: It is planned to include patients who are American Society of Anesthesiologists (ASA) III and between the ages of 18-80 who will undergo arteriovenous fistula surgery in the research population.In our study, patients who come to the operating room for arteriovenous fistula operation will be randomly divided into two groups.Patients who undergo simple randomization with coin toss method will be assigned to one of two groups: group Local infiltrative anesthesia (Local) and group infraclavicular brachial plexus block with 0.25% bupivacaine (Block). Local infiltrative anesthesia will be applied with 15 ml 2% prilocaine for group Local patients.For Group Block patients, 30 ml 0.25% bupivacaine will be applied with Infraclavicular approach around brachial plexus with inplane technique.Before the start of surgery, NIRS probes will be placed on the thenar ,antecubital regions of both hands and arms .The preoperative observed values and data of every 5 minutes during the operation will be recorded .

Eligibility criteria: Inclusion Criteria:

* ASA III
* 18-80 years old
* arteriovenous fistula operation

Exclusion Criteria:

* disabled patients
* mentally retarded
* patients with coagulopathy
* hemoglobinopathy
* patients with infection in the infraclavicular area
* local anesthetic history
* peripheral neuropathy
* peripheral arterial occlusion
* failed peripheral nerve block

Primary outcomes:
measure: tissue oxygenation
timeFrame: beginning and every 5 minutes till the end of surgery
measure: primary patency of the arteriovenous fistula
timeFrame: 1 month after the operation
Secondary outcomes:
measure: 5 Point Likert Scale
timeFrame: at the end of the operation
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
state: Çankaya
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Hija Yazıcıoğlu
role: PRINCIPAL_INVESTIGATOR
References: