Comparison of Infraclavicular Brachial Plexus Block and Local Anesthesia in Arteriovenous Fistula Surgeries and Their Effects on Tissue Oxygen Saturation
- Conditions
- Renal Disease, Chronic
- Interventions
- Registration Number
- NCT06416111
- Lead Sponsor
- Ankara City Hospital Bilkent
- 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 .
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- ASA III
- 18-80 years old
- arteriovenous fistula operation
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Local group(Group L) NIRS Local infiltrative anesthesia will be applied with 15 ml 2% prilocaine for Local group patients.Before surgery, NIRS probes will be placed on the thenar, antecubital regions of both hands and arms .The peripheral regional oxygen saturation values will be recorded preoperatively and every 5 minutes during the operation. Surgeon and patient satisfaction will be evaluated by 5 Point Likert Scale (worst: 1 point, best: 5 points) at the end of the surgery. Local group(Group L) Prilocaine Local infiltrative anesthesia will be applied with 15 ml 2% prilocaine for Local group patients.Before surgery, NIRS probes will be placed on the thenar, antecubital regions of both hands and arms .The peripheral regional oxygen saturation values will be recorded preoperatively and every 5 minutes during the operation. Surgeon and patient satisfaction will be evaluated by 5 Point Likert Scale (worst: 1 point, best: 5 points) at the end of the surgery. Block group(Group B) NIRS For Block group patients, 30 ml 0.25% bupivacaine will be applied with Infraclavicular approach around brachial plexus with inplane technique.The effect of the peripheral nerve block will be evaluated with 10-minute intervals until regional anesthesia is achieved.Sensory block will be evaluated with the "Pinprick Test" and motor block with the "Modified Bromage Scale". For patients who underwent a block, Grade 2 on the "Pinprick Test" and Grade 3 on the "Modified Bromage Scale" were considered suitable anesthesia conditions for the operation. Before surgery, NIRS probes will be placed on the thenar, antecubital regions of both hands and arms .The peripheral regional oxygen saturation values will be recorded preoperatively and every 5 minutes during the operation. Surgeon and patient satisfaction will be evaluated by 5 Point Likert Scale (worst: 1 point, best: 5 points) at the end of the surgery. Block group(Group B) Pinprick Test For Block group patients, 30 ml 0.25% bupivacaine will be applied with Infraclavicular approach around brachial plexus with inplane technique.The effect of the peripheral nerve block will be evaluated with 10-minute intervals until regional anesthesia is achieved.Sensory block will be evaluated with the "Pinprick Test" and motor block with the "Modified Bromage Scale". For patients who underwent a block, Grade 2 on the "Pinprick Test" and Grade 3 on the "Modified Bromage Scale" were considered suitable anesthesia conditions for the operation. Before surgery, NIRS probes will be placed on the thenar, antecubital regions of both hands and arms .The peripheral regional oxygen saturation values will be recorded preoperatively and every 5 minutes during the operation. Surgeon and patient satisfaction will be evaluated by 5 Point Likert Scale (worst: 1 point, best: 5 points) at the end of the surgery. Block group(Group B) Modified Bromage Scale For Block group patients, 30 ml 0.25% bupivacaine will be applied with Infraclavicular approach around brachial plexus with inplane technique.The effect of the peripheral nerve block will be evaluated with 10-minute intervals until regional anesthesia is achieved.Sensory block will be evaluated with the "Pinprick Test" and motor block with the "Modified Bromage Scale". For patients who underwent a block, Grade 2 on the "Pinprick Test" and Grade 3 on the "Modified Bromage Scale" were considered suitable anesthesia conditions for the operation. Before surgery, NIRS probes will be placed on the thenar, antecubital regions of both hands and arms .The peripheral regional oxygen saturation values will be recorded preoperatively and every 5 minutes during the operation. Surgeon and patient satisfaction will be evaluated by 5 Point Likert Scale (worst: 1 point, best: 5 points) at the end of the surgery. Block group(Group B) Bupivacaine For Block group patients, 30 ml 0.25% bupivacaine will be applied with Infraclavicular approach around brachial plexus with inplane technique.The effect of the peripheral nerve block will be evaluated with 10-minute intervals until regional anesthesia is achieved.Sensory block will be evaluated with the "Pinprick Test" and motor block with the "Modified Bromage Scale". For patients who underwent a block, Grade 2 on the "Pinprick Test" and Grade 3 on the "Modified Bromage Scale" were considered suitable anesthesia conditions for the operation. Before surgery, NIRS probes will be placed on the thenar, antecubital regions of both hands and arms .The peripheral regional oxygen saturation values will be recorded preoperatively and every 5 minutes during the operation. Surgeon and patient satisfaction will be evaluated by 5 Point Likert Scale (worst: 1 point, best: 5 points) at the end of the surgery.
- Primary Outcome Measures
Name Time Method tissue oxygenation beginning and every 5 minutes till the end of surgery To 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 fistula 1 month after the operation To compare the effects of infraclavicular brachial plexus block and local infiltrative anesthesia on the primary patency of the arteriovenous fistula
- Secondary Outcome Measures
Name Time Method 5 Point Likert Scale at the end of the operation Surgeon and patient satisfaction will be evaluated by 5 Point Likert Scale at the end of surgery.
1 point:Dissatisfaction; 5 point:Fully satisfied
Trial Locations
- Locations (1)
Ankara Bilkent City Hospital
🇹🇷Ankara, Çankaya, Turkey