Regional Anesthesia for Arteriovenous Fistula

NCT02305992 | Withdrawn

• 1 other identifier: 14-123
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Once kidney function goes below 10 to 15 percent of normal, dialysis treatments or a kidney transplant are necessary to sustain life. One type of dialysis is hemodialysis which cleans blood by removing it from the body and passing it through a dialyzer, or artificial kidney. To maximize the amount of blood cleansed during hemodialysis treatments, there should be continuous high volumes of blood flow. A fistula used for hemodialysis is a direct connection of an artery to a vein. Once an arteriovenous fistula (AVF) is created it is a natural part of the body. This is the preferred type of access because once the fistula properly matures and gets bigger and stronger; it provides an access with good blood flow that can last for decades. After the fistula is surgically created, it can take weeks to months before the fistula matures and is ready to be used for hemodialysis. There have been surgical factors identified; one of them being the anesthetic used which may cause a fistula not to survive. This study will look at comparing 3 anesthetic techniques: axillary block (AB) versus stellate ganglion (SGB) block+local anesthetic versus local anesthetic (LA).

Conditions

Arteriovenous Fistula

Outcome Measures

Primary Outcomes (1)

• Arteriovenous fistula flow

  Arteriovenous fistula in mL/min

  1 hour post-operatively

Secondary Outcomes (6)

• Change in limb temperature pre-anesthetic and post-anesthetics

  1 hour post-operatively

• Duration of intraoperative procedure

  3 hours post-operatively

• Rate of conversion to general anesthetic

  1 day post-operatively

• Anesthesia-related adverse events

  1 day post-operatively

• Maturation time

  2 months post-operatively

Study Arms (3)

Axillary Block with 0.5% Ropivicaine

EXPERIMENTAL

Patients will receive an axillary block using an ultrasound-guided technique. After skin infiltration with 1 mL of 2% lidocaine, a 22-gauge insulated needle is advanced in-plane from the cephalic aspect of the transducer toward the posterior aspect of the axillary artery. Prior to injection, the syringe is aspirated to confirm extra-vascular placement of the needle. 20 mL solution of 0.5% ropivicaine is then injected slowly, with syringe aspiration after every 5 mL injection to confirm extravascular placement.

Procedure: Axillary Block with 0.5% Ropivicaine

Stellate Ganglion Block with 0.2% Ropivicaine

EXPERIMENTAL

Patients will receive stellate ganglion block and local anesthetic using an ultrasound-guided technique.After skin infiltration with 1 mL of 2% lidocaine, a 22-gauge insulated needle is advanced in-plane from the lateral position toward the anterior aspect of longus colli muscle just posterior to the internal jugular vein. Prior to injection, the syringe is aspirated to confirm extra-vascular placement of the needle. 10 mL of 0.2% ropivicaine is then injected slowly, with syringe aspiration after every 5 mL injection to confirm extravascular placement.

Procedure: Stellate ganglion block with 0.2% Ropivicaine

Local anesthetic infiltration with 0.25% Bupivicaine

ACTIVE COMPARATOR

Patients will receive local anesthetic infiltration of 0.25% Bupivicaine at the surgical site which will last approximately 6 hours.

Procedure: Local anesthetic infiltration with 0.25% Bupivicaine

Interventions

Axillary Block with 0.5% Ropivicaine PROCEDURE

Axillary blocks are regional anesthesia techniques that are sometimes employed as an alternative to general anesthesia for surgery of the shoulder, arm, forearm, wrist and hand. In this case, ultra-sound technique will be used.

Axillary Block with 0.5% Ropivicaine

Local anesthetic infiltration with 0.25% Bupivicaine PROCEDURE

Patients will receive local anesthetic infiltration of 0.25% Bupivicaine at the surgical site which will last approximately 6 hours.

Local anesthetic infiltration with 0.25% Bupivicaine

Stellate ganglion block with 0.2% Ropivicaine PROCEDURE

A stellate ganglion block is an injection of local anesthetic in the sympathetic nerve tissue of the neck. These nerves are a part of the sympathetic nervous system. The nerves are located on either side of the voice box, in the neck

Stellate Ganglion Block with 0.2% Ropivicaine

Eligibility Criteria

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

You may qualify if:

• Patients with ESRD undergoing radio-cephalic AVF

You may not qualify if:

• Previous AVF procedures
• significant stenosis (\>50% diameter reduction)
• calcifications of radial artery or cephalic vein
• radial artery diameter \<1.6mm
• cephalic vein diameter \<2.0mm
• history of pre-existing unilateral recurrent laryngeal nerve palsy
• pre-existing unilateral phrenic nerve palsy
• coagulopathy or pre-existing conditions that require anticoagulants or anti-platelet therapies
• history of IV drug use
• documented allergic reactions to local anesthetics
• pregnancy
• morbid obesity.

Sponsors & Collaborators

• McMaster University: lead
• St. Joseph's Healthcare Hamilton: collaborator

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (3)

• Allon M, Robbin ML. Increasing arteriovenous fistulas in hemodialysis patients: problems and solutions. Kidney Int. 2002 Oct;62(4):1109-24. doi: 10.1111/j.1523-1755.2002.kid551.x.

  PMID: 12234281 BACKGROUND

• He GW, Yang CQ. Radial artery has higher receptor-mediated contractility but similar endothelial function compared with mammary artery. Ann Thorac Surg. 1997 May;63(5):1346-52. doi: 10.1016/s0003-4975(97)00106-9.

  PMID: 9146326 BACKGROUND

• Fries A. [Environmental access to a rehabilitation center as a determinant of attitude to handicapped persons? A comparative empirical study of assumptions of the "contact hypothesis"]. Rehabilitation (Stuttg). 1991 Feb;30(1):28-37. German.

  PMID: 1828300 BACKGROUND

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Turlough O'Hare, MD

  St. Joseph's Healthcare Hamilton/McMaster Univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2014
• First Posted: December 3, 2014
• Study Start: December 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

CA (1)