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Arteriovenous FistulaNCT02305992

Regional Anesthesia for Arteriovenous Fistula

A study testing Axillary Block with 0.5% Ropivicaine, Stellate ganglion block with 0.2% Ropivicaine and Local anesthetic infiltration with 0.25% Bupivicaine in people with Arteriovenous Fistula, run by McMaster University at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Arteriovenous Fistula
What is being tested?
Axillary Block with 0.5% Ropivicaine, Stellate ganglion block with 0.2% Ropivicaine and Local anesthetic infiltration with 0.25% Bupivicaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteCanada
Study dates
Dec 2015to Dec 2017
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with ESRD undergoing radio-cephalic AVF

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

Other trials in Canada

About this study

Official title: Effect of Sympathetic Blockade on the Success and Survival of Arteriovenous Fistula

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).

Read the detailed description

To allow for chronic hemodialysis (HD), patients with end-stage renal disease (ESRD) require permanent vascular access in the form of either arteriovenous graft (AVG) or arteriovenous fistula (AVF). The latter option is the preferred form of vascular access given the lower rate of thrombosis, fewer interventions required, longer survival for vascular access and lower rate of infection as compared to AVG (1). Despite this, earlier reports have suggested that the initial failure rate of AVF approximates to 25% (2). A permanent vascular access is considered adequate when it has sufficient size (i.e. greater than 0.6 cm) for easy cannulation and a flow rate of approximately 600 mL/min for dialysis (1, 3). However, postoperative AVF blood flow may be compromised by arterial vasospasm and sympathetic activity from surgical manipulations (4, 5). Inadequate flow rate in the postoperative period can result in early thrombus formation at the fistula and, if left untreated, can lead to permanent loss of vascular access(6). Over the years, researchers have identified a number of patient and surgical factors that may influence the success and long-term survival of AVF, and recent evidence suggests that the choice of anesthetic techniques may play a significant role (7).

Vascular access surgery is usually conducted under either a) general anesthesia (GA), b) local anesthetics (LA) infiltrations with sedations, or c) regional anesthesia in the form of brachial plexus block (BPB). GA, while providing both anesthesia and analgesia, can present a challenge for maintaining intraoperative hemodynamic stability as patients with ESRD often have other significant comorbidities. LA infiltrations, though offering simplicity, does not provide motor blockade and patient movement can be a surgical challenge. LA requires multiple injections during the case. BPB thus presents as an attractive option as it provides both dense and prolonged sensory and motor blockade while avoiding the cardiopulmonary stress imposed by GA. Additionally, the sympathectomy associated with BPB has been shown to improve postoperative AVF blood flow through decreasing peripheral vascular resistance and increasing vasodilation and blood flow velocity (8-11). Similarly, stellate ganglion block (SGB), which offers sympathetic blockade without analgesic effect, has also been shown to augment postoperative AVF blood flow and average peak flow velocity and shorten maturation time when combined with LA infiltrations (5, 12).

Though it has been shown that regional anesthesia can affect a number of physiological parameters following AVF formation, it is not yet clear how fistula survival can be affected by the modification of these parameters. The investigators conducted a literature search in July 2013 using MEDLINE database. Two key words, one from List A and one from List B, were joined with the term "and" in all possible combinations for the literature search. Key words from List A included "arteriovenous fistula", "AVF", "vascular access", "dialysis", and "dialysis access". List B included "regional anesthesia", "brachial plexus block," "BPB", "brachial plexus", "stellate ganglion", "SGB", "sympathectomy", "supraclavicular", "infraclavicular", "axillary", and "interscalene". Search results were limited to English articles only. Abstracts were not included in the search results. To the investigators knowledge, no randomized trial has been conducted to directly compare the effect of axillary block (AB) against LA infiltration with or without SGB on AVF success in patients with ESRD. This will be the primary objective of the investigators study. To do so, the investigators intend to conduct a prospective randomized controlled trial at a tertiary vascular surgical center in Hamilton.

Being tested
Axillary Block with 0.5% Ropivicaine, Stellate ganglion block with 0.2% Ropivicaine, Local anesthetic infiltration with 0.25% Bupivicaine
Medical subject headings
Arteriovenous Fistula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Axillary Block with 0.5% RopivicaineProcedure or surgery

    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.

  • Stellate ganglion block with 0.2% RopivicaineProcedure or surgery

    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

  • Local anesthetic infiltration with 0.25% BupivicaineProcedure or surgery

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

Study groups in NCT02305992
Study groupRoleWhat they receive
Axillary Block with 0.5% RopivicaineExperimentalPatients 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.
Receives: Procedure: Axillary Block with 0.5% Ropivicaine
Stellate Ganglion Block with 0.2% RopivicaineExperimentalPatients 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.
Receives: Procedure: Stellate ganglion block with 0.2% Ropivicaine
Local anesthetic infiltration with 0.25% BupivicaineActive comparatorPatients will receive local anesthetic infiltration of 0.25% Bupivicaine at the surgical site which will last approximately 6 hours.
Receives: Procedure: Local anesthetic infiltration with 0.25% Bupivicaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Arteriovenous fistula flow

    Arteriovenous fistula in mL/min

    Measured: 1 hour post-operatively

Secondary outcomes (6)
  1. Change in limb temperature pre-anesthetic and post-anesthetics

    Measured: 1 hour post-operatively

  2. Duration of intraoperative procedure

    Measured: 3 hours post-operatively

  3. Rate of conversion to general anesthetic

    Measured: 1 day post-operatively

  4. Anesthesia-related adverse events

    Measured: 1 day post-operatively

  5. Maturation time

    Measured: 2 months post-operatively

  6. Patient Satisfaction

    Measured: 2 months post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2014 (estimated)
  2. Study startDec 2015
  3. Primary completionDec 2017
  4. Study completionDec 2017

Why it stopped: Looking for funding opportunities

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02305992
Sponsor's protocol ID
14-123
Status last verified
Jun 2026
First submitted
11 Nov 2014
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 12234281
  • 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.

    PubMed 9146326
  • 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.

    PubMed 1828300

Questions about this trial

What is this clinical trial studying?

A study testing Axillary Block with 0.5% Ropivicaine, Stellate ganglion block with 0.2% Ropivicaine and Local anesthetic infiltration with 0.25% Bupivicaine in people with Arteriovenous Fistula, run by McMaster University at 1 site in Canada.

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 1 inclusion and 12 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: withdrawn, as of the sponsor's last update on 10 Jun 2026. 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 Canada. 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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arteriovenous fistula flow (time frame: 1 hour post-operatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02305992, which also lists 3 linked publications.

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 10 Jun 2026.

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