The Minimum Effective Concentration of Lidocaine for Ultrasound-guided Axillary Block for Arterio-venous Fistula Creation Surgery
Primary Purpose
Anesthesia
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Lidocaine 2% Injectable Solution
Sponsored by
About this trial
This is an interventional treatment trial for Anesthesia
Eligibility Criteria
Inclusion Criteria:
- ASA classification I to III
- Operation site : First time undergone surgery
Exclusion Criteria:
- 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
- Peripheral neuropathy
- Patient with psychiatric disease
- Coagulopathy, or patient taking anti-coagulant
Sites / Locations
- Chen Yen HuaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Participant
Arm Description
Outcomes
Primary Outcome Measures
Minimal effective concentration of lidocaine solution
To test the sensory and motor blockade after local anesthetics being injected by dermatome testing of upper extremity
Secondary Outcome Measures
Functional Dialysis
Percentage (%) of patient who under gone hemodialysis via the fistula created
Full Information
NCT ID
NCT05063578
First Posted
September 8, 2021
Last Updated
September 21, 2021
Sponsor
Far Eastern Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05063578
Brief Title
The Minimum Effective Concentration of Lidocaine for Ultrasound-guided Axillary Block for Arterio-venous Fistula Creation Surgery
Official Title
The Minimum Effective Concentration of Lidocaine for Ultrasound-guided Axillary Block for Arterio-venous Fistula Creation Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 20, 2021 (Anticipated)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Far Eastern Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participant
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lidocaine 2% Injectable Solution
Intervention Description
Different concentration of lidocaine, injected via axillary block for arterio-venous fistula creation surgery
Primary Outcome Measure Information:
Title
Minimal effective concentration of lidocaine solution
Description
To test the sensory and motor blockade after local anesthetics being injected by dermatome testing of upper extremity
Time Frame
Before the operation
Secondary Outcome Measure Information:
Title
Functional Dialysis
Description
Percentage (%) of patient who under gone hemodialysis via the fistula created
Time Frame
six weeks after the operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA classification I to III
Operation site : First time undergone surgery
Exclusion Criteria:
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
Peripheral neuropathy
Patient with psychiatric disease
Coagulopathy, or patient taking anti-coagulant
Facility Information:
Facility Name
Chen Yen Hua
City
New Taipei City
ZIP/Postal Code
220
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yen Hua Chen, MD
Phone
886910003805
Email
yanhua0624@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Minimum Effective Concentration of Lidocaine for Ultrasound-guided Axillary Block for Arterio-venous Fistula Creation Surgery
We'll reach out to this number within 24 hrs