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Regional Anesthesia for Arteriovenous Fistula

Primary Purpose

Arteriovenous Fistula

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Axillary Block with 0.5% Ropivicaine
Stellate ganglion block with 0.2% Ropivicaine
Local anesthetic infiltration with 0.25% Bupivicaine
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arteriovenous Fistula

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with ESRD undergoing radio-cephalic AVF

Exclusion Criteria:

  • 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.

Sites / Locations

  • St. Joseph's Healthcare Hamilton

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Axillary Block with 0.5% Ropivicaine

Stellate Ganglion Block with 0.2% Ropivicaine

Local anesthetic infiltration with 0.25% Bupivicaine

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

Arteriovenous fistula flow
Arteriovenous fistula in mL/min

Secondary Outcome Measures

Change in limb temperature pre-anesthetic and post-anesthetics
Duration of intraoperative procedure
Rate of conversion to general anesthetic
Anesthesia-related adverse events
Maturation time
Patient Satisfaction

Full Information

First Posted
November 11, 2014
Last Updated
March 20, 2018
Sponsor
McMaster University
Collaborators
St. Joseph's Healthcare Hamilton
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1. Study Identification

Unique Protocol Identification Number
NCT02305992
Brief Title
Regional Anesthesia for Arteriovenous Fistula
Official Title
Effect of Sympathetic Blockade on the Success and Survival of Arteriovenous Fistula
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Looking for funding opportunities
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
St. Joseph's Healthcare Hamilton

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriovenous Fistula

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Axillary Block with 0.5% Ropivicaine
Arm Type
Experimental
Arm Description
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.
Arm Title
Stellate Ganglion Block with 0.2% Ropivicaine
Arm Type
Experimental
Arm Description
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.
Arm Title
Local anesthetic infiltration with 0.25% Bupivicaine
Arm Type
Active Comparator
Arm Description
Patients will receive local anesthetic infiltration of 0.25% Bupivicaine at the surgical site which will last approximately 6 hours.
Intervention Type
Procedure
Intervention Name(s)
Axillary Block with 0.5% Ropivicaine
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Stellate ganglion block with 0.2% Ropivicaine
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Local anesthetic infiltration with 0.25% Bupivicaine
Intervention Description
Patients will receive local anesthetic infiltration of 0.25% Bupivicaine at the surgical site which will last approximately 6 hours.
Primary Outcome Measure Information:
Title
Arteriovenous fistula flow
Description
Arteriovenous fistula in mL/min
Time Frame
1 hour post-operatively
Secondary Outcome Measure Information:
Title
Change in limb temperature pre-anesthetic and post-anesthetics
Time Frame
1 hour post-operatively
Title
Duration of intraoperative procedure
Time Frame
3 hours post-operatively
Title
Rate of conversion to general anesthetic
Time Frame
1 day post-operatively
Title
Anesthesia-related adverse events
Time Frame
1 day post-operatively
Title
Maturation time
Time Frame
2 months post-operatively
Title
Patient Satisfaction
Time Frame
2 months post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with ESRD undergoing radio-cephalic AVF Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Turlough O'Hare, MD
Organizational Affiliation
St. Joseph's Healthcare Hamilton/McMaster Univeristy
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
12234281
Citation
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.
Results Reference
background
PubMed Identifier
9146326
Citation
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.
Results Reference
background
PubMed Identifier
1828300
Citation
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.
Results Reference
background

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Regional Anesthesia for Arteriovenous Fistula

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