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Comparison of Infraclavicular Brachial Plexus Block and Local Anesthesia in Arteriovenous Fistula Surgeries and Their Effects on Tissue Oxygen Saturation

Comparison of Infraclavicular Brachial Plexus Block and Local Anesthesia in Arteriovenous Fistula Surgeries and Their Effects on Tissue Oxygen Saturation With Near-infrared Spectroscopy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06416111
Enrollment
60
Registered
2024-05-16
Start date
2023-10-22
Completion date
2024-10-10
Last updated
2025-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Disease, Chronic

Keywords

arteriovenous fistula operation, Infraclavicular nerve block, Near-infrared spectroscopy (NIRS), local anesthesia

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 .

Interventions

DEVICENIRS

Near Infra-Red Spectroscopy (NIRS) is a non-invasive monitoring modality which measures regional tissue oxygenation defined as percentage (%).

With the pinprick test, the practitioner gently touches the skin with the pin and asks the patient whether it feels sharp or blunt .Test begins distally and then move proximally (aiming to test each dermatome and each main nerve). Assessment of sensorial blockade uses 3 grade system. Grade 0.Sharp pain Grade 1.Analgesia ,numbness Grade 2.Anesthesia ,no feeling

OTHERModified Bromage Scale

Assessment of motor blockade uses 4 point Modified Bromage Score. 0.Normal motor function with full extension and flexion of elbow, wrist and fingers 1. Decreased motor strengths with ability to full flexion elbow and move fingers but inability to raise arm 2. More decreased motor strengths with inability to move elbow but ability to move fingers 3.Complete motor block with inability to move elbow, wrist, and fingers.

DRUGBupivacaine

Bupivacaine is a potent local anesthetic with unique characteristics from the amide group of local anesthetics.

Prilocaine is an amide local anesthetic secondary amine with an intermediate length of duration and quick onset of action.

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
tissue oxygenationbeginning and every 5 minutes till the end of surgeryTo compare the effects of infraclavicular brachial plexus block and local infiltrative anesthesia on tissue oxygenation during arteriovenous fistula (AVF) surgeries. Near Infra-Red Spectroscopy (NIRS) is a non-invasive monitoring modality which measures regional tissue oxygenation defined as percentage (%).Before surgery, NIRS probes will be placed on the thenar, antecubital regions of both hands and arms .
primary patency of the arteriovenous fistula1 month after the operationTo compare the effects of infraclavicular brachial plexus block and local infiltrative anesthesia on the primary patency of the arteriovenous fistula

Secondary

MeasureTime frameDescription
5 Point Likert Scaleat the end of the operationSurgeon and patient satisfaction will be evaluated by 5 Point Likert Scale at the end of surgery. 1 point:Dissatisfaction; 5 point:Fully satisfied

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026