Renal Disease, ChronicNCT06416111
Comparison of Infraclavicular Brachial Plexus Block and Local Anesthesia in Arteriovenous Fistula Surgeries and Their Effects on Tissue Oxygen Saturation
A study testing NIRS, Pinprick Test and Modified Bromage Scale in people with Renal Disease, Chronic, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Disease, Chronic
- What is being tested?
- NIRS, Pinprick Test and Modified Bromage Scale
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Oct 2023to 10 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA III
- 18-80 years old
- arteriovenous fistula operation
Who cannot join
- disabled patients
- mentally retarded
- patients with coagulopathy
- hemoglobinopathy
- patients with infection in the infraclavicular area
- local anesthetic history
Show all 9Show fewer
- peripheral neuropathy
- peripheral arterial occlusion
- failed peripheral nerve block
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Çankaya, 06800
About this study
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
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.
Read the 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 .
- Conditions
- Renal Disease, Chronic
- Being tested
- NIRS, Pinprick Test, Modified Bromage Scale, Bupivacaine, Prilocaine
- Keywords
- arteriovenous fistula operation, Infraclavicular nerve block, Near-infrared spectroscopy (NIRS), local anesthesia
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRSDevice
Near Infra-Red Spectroscopy (NIRS) is a non-invasive monitoring modality which measures regional tissue oxygenation defined as percentage (%).
Pinprick TestOther
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
Modified Bromage ScaleOther
Assessment of motor blockade uses 4 point Modified Bromage Score. 0.Normal motor function with full extension and flexion of elbow, wrist and fingers
- Decreased motor strengths with ability to full flexion elbow and move fingers but inability to raise arm
- 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.
BupivacaineDrug
Also called Marcaine, Sensorcaine
Bupivacaine is a potent local anesthetic with unique characteristics from the amide group of local anesthetics.
PrilocaineDrug
Also called Citanest, Propitocaine, Xylonest
Prilocaine is an amide local anesthetic secondary amine with an intermediate length of duration and quick onset of action.
| Study group | Role | What they receive |
|---|---|---|
| Local group(Group L) | Active comparator | 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. Receives: Device: NIRS; Drug: Prilocaine |
| Block group(Group B) | Active comparator | 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. Receives: Device: NIRS; Other: Pinprick Test; Other: Modified Bromage Scale; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
tissue oxygenation
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 .
Measured: beginning and every 5 minutes till the end of surgery
primary patency of the arteriovenous fistula
To compare the effects of infraclavicular brachial plexus block and local infiltrative anesthesia on the primary patency of the arteriovenous fistula
Measured: 1 month after the operation
Secondary outcomes (1)
5 Point Likert Scale
Surgeon and patient satisfaction will be evaluated by 5 Point Likert Scale at the end of surgery.
1 point:Dissatisfaction; 5 point:Fully satisfied
Measured: at the end of the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start22 Oct 2023
- Primary completion10 Sep 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Disease, ChronicStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hija Yazıcıoğlu, Ankara City Hospital Bilkent
- Investigators
- Hija Yazıcıoğlu, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416111
- Sponsor's protocol ID
- Tissue Oxygen Saturation
- Status last verified
- Jan 2025
- First submitted
- 26 Apr 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06416111
- Acronym / sponsor ID
- Tissue Oxygen Saturation
- Conditions
- Renal Disease, Chronic
- Keywords
- arteriovenous fistula operation, Infraclavicular nerve block, Near-infrared spectroscopy (NIRS), local anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 22 Oct 2023 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Local group(Group L) | Active comparator | Device: NIRS, Drug: PrilocaineLocal 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) | Active comparator | Device: NIRS, Other: Pinprick Test, Other: Modified Bromage Scale, Drug: BupivacaineFor 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA III
- 18-80 years old
- arteriovenous fistula operation
Key exclusion criteria (9 listed)
- disabled patients
- mentally retarded
- patients with coagulopathy
- hemoglobinopathy
- patients with infection in the infraclavicular area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIRSNear Infra-Red Spectroscopy (NIRS) is a non-invasive monitoring modality which measures regional tissue oxygenation defined as percentage (%). | Device | Block group(Group B), Local group(Group L) |
| Pinprick TestWith 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 | Other | Block group(Group B) |
| Modified Bromage ScaleAssessment 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. | Other | Block group(Group B) |
| BupivacaineAlso: Marcaine, SensorcaineBupivacaine is a potent local anesthetic with unique characteristics from the amide group of local anesthetics. | Drug | Block group(Group B) |
| PrilocaineAlso: Citanest, Propitocaine, XylonestPrilocaine is an amide local anesthetic secondary amine with an intermediate length of duration and quick onset of action. | Drug | Local group(Group L) |
Primary outcome
tissue oxygenation
Time frame: 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
Time frame: 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
1 secondary outcome
5 Point Likert Scale
Time frame: at the end of the operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hija Yazıcıoğlu principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIRS, Pinprick Test and Modified Bromage Scale in people with Renal Disease, Chronic, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tissue oxygenation (time frame: beginning and every 5 minutes till the end of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.