- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02305992
Regional Anesthesia for Arteriovenous Fistula
Effect of Sympathetic Blockade on the Success and Survival of Arteriovenous Fistula
Study Overview
Status
Conditions
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N 4A6
- St. Joseph's Healthcare Hamilton
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Axillary Block with 0.5% Ropivicaine
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.
|
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.
|
Experimental: Stellate Ganglion Block with 0.2% Ropivicaine
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.
|
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
|
Active Comparator: Local anesthetic infiltration with 0.25% Bupivicaine
Patients will receive local anesthetic infiltration of 0.25% Bupivicaine at the surgical site which will last approximately 6 hours.
|
Patients will receive local anesthetic infiltration of 0.25% Bupivicaine at the surgical site which will last approximately 6 hours.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Arteriovenous fistula flow
Time Frame: 1 hour post-operatively
|
Arteriovenous fistula in mL/min
|
1 hour post-operatively
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in limb temperature pre-anesthetic and post-anesthetics
Time Frame: 1 hour post-operatively
|
1 hour post-operatively
|
Duration of intraoperative procedure
Time Frame: 3 hours post-operatively
|
3 hours post-operatively
|
Rate of conversion to general anesthetic
Time Frame: 1 day post-operatively
|
1 day post-operatively
|
Anesthesia-related adverse events
Time Frame: 1 day post-operatively
|
1 day post-operatively
|
Maturation time
Time Frame: 2 months post-operatively
|
2 months post-operatively
|
Patient Satisfaction
Time Frame: 2 months post-operatively
|
2 months post-operatively
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Turlough O'Hare, MD, St. Joseph's Healthcare Hamilton/McMaster Univeristy
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Congenital Abnormalities
- Pathological Conditions, Anatomical
- Cardiovascular Abnormalities
- Vascular Malformations
- Arteriovenous Malformations
- Vascular Fistula
- Fistula
- Arteriovenous Fistula
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anesthetics, Local
- Bupivacaine
Other Study ID Numbers
- 14-123
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Arteriovenous Fistula
-
Medtronic EndovascularCompletedFistula | Arteriovenous Fistula | Arteriovenous Fistula Stenosis | Arteriovenous Fistula OcclusionNew Zealand, United States, Japan
-
MedtronicRecruitingFistula | Arteriovenous Fistula | Arteriovenous Fistula Stenosis | Arteriovenous Fistula OcclusionUnited States
-
Hospital General Universitario Gregorio MarañonSpanish Society of NephrologyCompletedArteriovenous Fistula Stenosis | Arteriovenous Fistula ThrombosisSpain
-
Ai PengRecruitingArteriovenous Fistula Flow Monitoring | Early Detection of Complications of Arteriovenous Fistula | VoiceprintChina
-
Rennes University HospitalTerminatedStenosis of Arteriovenous Dialysis FistulaFrance
-
Fundación Pública Andaluza Progreso y SaludCompletedArteriovenous Fistula Renal Dialysis Devices ObstructionSpain
-
Centre hospitalier de l'Université de Montréal...Biotronik Canada IncCompletedArteriovenous Graft | Arteriovenous FistulaeCanada
-
Henry Ford Health SystemAnalogic CorporationCompletedArteriovenous Fistula, CannulationUnited States
-
National Taiwan University HospitalCompletedArteriovenous Fistula OcclusionTaiwan
-
Acotec Scientific Co., LtdCompleted
Clinical Trials on Axillary Block with 0.5% Ropivicaine
-
University of California, San FranciscoCompletedPost-operative Surgical PainUnited States
-
University of PennsylvaniaCompletedOsteoarthritis | Total Knee Arthroplasty | Post Operative Pain ControlUnited States
-
Duke UniversityPfizerCompletedOsteoarthritisUnited States
-
Lawson Health Research InstituteCompletedDisorder of Rotator CuffCanada
-
Istanbul UniversityCompletedShoulder Arthroplasty | Ultrasound GuidedTurkey
-
Lawson Health Research InstituteCompletedObesity | Morbid ObesityCanada
-
National Institute of Oncology, HungaryCompleted
-
Medical University of South CarolinaCompletedHealthyUnited States
-
Stanford UniversitySuspendedLymphedema | Lymphedema, Breast CancerUnited States
-
University of California, San DiegoTerminatedAdhesive Capsulitis | Post-operative PainUnited States