AnesthesiaNCT05063578
The Minimum Effective Concentration of Lidocaine for Ultrasound-guided Axillary Block for Arterio-venous Fistula Creation Surgery
A study testing Lidocaine 2% Injectable Solution in people with Anesthesia, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
The arteriovenous fistula creation (AVF creation) surgery is essential among patients with end stage renal disease who require hemodialysis. The fistula usually locates at forearm, and is created by connecting artery and vein through surgery. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Lidocaine 2% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Sep 2021to 31 Dec 2022
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA classification I to III
- Operation site : First time undergone surgery
Who cannot join
- ASA classification IV to V
- Previous operation at surgical site before
- Allergy to local anesthetics
- Infectious state of injection point
- Neuromuscular disease causing preoperative numbness or weakness of extremities
- History of vascular thromboembolism including stroke, pulmonary embolism
Show all 9Show fewer
- Peripheral neuropathy
- Patient with psychiatric disease
- Coagulopathy, or patient taking anti-coagulant
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chen Yen Hua
New Taipei City, 220
Yen Hua Chen, MD, 886910003805, yanhua0624@gmail.com
About this study
The arteriovenous fistula creation (AVF creation) surgery is essential among patients with end stage renal disease who require hemodialysis. The fistula usually locates at forearm, and is created by connecting artery and vein through surgery. Patients undergone hemodialysis through the fistula six weeks later if fistula becoming mature, which means patent vessel diameter and enough flow for hemodialysis. The primary failure rate of arteriovenous fistula creation is about 20% to 40% according to previous research data. Thrombosis is the most common cause of fistula failure, which require surgical intervention after arteriovenous fistula surgery.
Anesthetic technique influences surgical outcome of arteriovenous fistula. General anesthesia, regional anesthesia, and local anesthesia are both wide-used methods. Regional anesthesia with nerve block remains the most popular method for arteriovenous fistula creation. The vessel dilation effect of regional anesthesia helps not only dilatation of artery and vein, but also the fistula itself, and promotes the successful functional dialysis. Various type of nerve block are used as anesthetic method for AVF creation surgery.
People requiring hemodialysis usually have multiple underlying disease involving other major organ such as heart, lung, liver, and the endocrine system. They are more vulnerable to systemic intravenous anesthetic medication. The metabolic rate and pharmacodynamics of local anesthetic may also alter due to multiple systemic disease when compared with healthy adults. The optimal concentration of lidocaine for AVF creation when using axillary block has not yet been studied. This research is conducted for dosing response of different concentration of lidocaine when using axillary block for AVF creation surgery. We aim to investigate the optimal low effective concentration, the MEC90, which defined as 90% of patients can tolerate the operation at this concentration.
- Conditions
- Anesthesia
- Being tested
- Lidocaine 2% Injectable Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 2% Injectable SolutionDrug
Different concentration of lidocaine, injected via axillary block for arterio-venous fistula creation surgery
| Study group | Role | What they receive |
|---|---|---|
| Participant | Experimental | Not described Receives: Drug: Lidocaine 2% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal effective concentration of lidocaine solution
To test the sensory and motor blockade after local anesthetics being injected by dermatome testing of upper extremity
Measured: Before the operation
Secondary outcomes (1)
Functional Dialysis
Percentage (%) of patient who under gone hemodialysis via the fistula created
Measured: six weeks after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start20 Sep 2021 (estimated)
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yen-Hua Chen, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063578
- Sponsor's protocol ID
- 110122-F
- Status last verified
- Sep 2021
- First submitted
- 8 Sep 2021
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Minimum Effective Concentration of Lidocaine for Ultrasound-guided Axillary Block for Arterio-venous Fistula Creation Surgery
- ClinicalTrials.gov ID
- NCT05063578
- Acronym / sponsor ID
- 110122-F
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 20 Sep 2021 (estimated)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 1 Oct 2021 (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.
The arteriovenous fistula creation (AVF creation) surgery is essential among patients with end stage renal disease who require hemodialysis. The fistula usually locates at forearm, and is created by connecting artery and vein through surgery. Patients undergone hemodialysis through the fistula six weeks later if fistula becoming mature, which means patent vessel diameter and enough flow for hemodialysis. The primary failure rate of arteriovenous fistula creation is about 20% to 40% according to previous research data. Thrombosis is the most common cause of fistula failure, which require surgical intervention after arteriovenous fistula surgery.
Anesthetic technique influences surgical outcome of arteriovenous fistula. General anesthesia, regional anesthesia, and local anesthesia are both wide-used methods. Regional anesthesia with nerve block remains the most popular method for arteriovenous fistula creation. The vessel dilation effect of regional anesthesia helps not only dilatation of artery and vein, but also the fistula itself, and promotes the successful functional dialysis. Various type of nerve block are used as anesthetic method for AVF creation surgery.
People requiring hemodialysis usually have multiple underlying disease involving other major organ such as heart, lung, liver, and the endocrine system. They are more vulnerable to systemic intravenous anesthetic medication. The metabolic rate and pharmacodynamics of local anesthetic may also alter due to multiple systemic disease when compared with healthy adults. The optimal concentration of lidocaine for AVF creation when using axillary block has not yet been studied. This research is conducted for dosing response of different concentration of lidocaine when using axillary block for AVF creation surgery. We aim to investigate the optimal low effective concentration, the MEC90, which defined as 90% of patients can tolerate the operation at this concentration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant | Experimental | Drug: Lidocaine 2% Injectable Solution |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA classification I to III
- Operation site : First time undergone surgery
Key exclusion criteria (9 listed)
- ASA classification IV to V
- Previous operation at surgical site before
- Allergy to local anesthetics
- Infectious state of injection point
- Neuromuscular disease causing preoperative numbness or weakness of extremities
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 |
|---|---|---|
| Lidocaine 2% Injectable SolutionDifferent concentration of lidocaine, injected via axillary block for arterio-venous fistula creation surgery | Drug | Participant |
Primary outcome
Minimal effective concentration of lidocaine solution
Time frame: Before the operation
To test the sensory and motor blockade after local anesthetics being injected by dermatome testing of upper extremity
1 secondary outcome
Functional Dialysis
Time frame: six weeks after the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine 2% Injectable Solution in people with Anesthesia, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 2 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: status not confirmed, as of the sponsor's last update on 1 Oct 2021. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimal effective concentration of lidocaine solution (time frame: Before the operation). 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 1 Oct 2021.