The Minimum Effective Concentration of Lidocaine for Ultrasound-guided Axillary Block for Arterio-venous Fistula Creation Surgery

NCT05063578 | Unknown DMC

• 1 other identifier: 110122-F
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Minimal effective concentration of lidocaine solution

  To test the sensory and motor blockade after local anesthetics being injected by dermatome testing of upper extremity

  Before the operation

Secondary Outcomes (1)

• Functional Dialysis

  six weeks after the operation

Study Arms (1)

Participant

EXPERIMENTAL

Drug: Lidocaine 2% Injectable Solution

Interventions

Lidocaine 2% Injectable Solution DRUG

Different concentration of lidocaine, injected via axillary block for arterio-venous fistula creation surgery

Participant

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA classification I to III
• Operation site : First time undergone surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Chen Yen Hua

New Taipei City, 220, Taiwan

RECRUITING

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: October 1, 2021
• Study Start: September 20, 2021
• Primary Completion: August 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 1, 2021

Record last verified: 2021-09

Locations

TW (1)