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

Sponsor
Far Eastern Memorial Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05063578
Collaborator
(none)
80
1
1
15.3
5.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lidocaine 2% Injectable Solution
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Minimum Effective Concentration of Lidocaine for Ultrasound-guided Axillary Block for Arterio-venous Fistula Creation Surgery
Anticipated Study Start Date :
Sep 20, 2021
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Participant

Drug: Lidocaine 2% Injectable Solution
Different concentration of lidocaine, injected via axillary block for arterio-venous fistula creation surgery

Outcome Measures

Primary Outcome Measures

  1. Minimal effective concentration of lidocaine solution [Before the operation]

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

Secondary Outcome Measures

  1. Functional Dialysis [six weeks after the operation]

    Percentage (%) of patient who under gone hemodialysis via the fistula created

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chen Yen Hua New Taipei City Taiwan 220

Sponsors and Collaborators

  • Far Eastern Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yen-Hua Chen, Department of Anesthesiology, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT05063578
Other Study ID Numbers:
  • 110122-F
First Posted:
Oct 1, 2021
Last Update Posted:
Oct 1, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 1, 2021