- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01706354
Local Anaesthesia vs Regional Block for Arteriovenous Fistulae
Does Regional Compared to Local Anaesthesia Influence Outcome After Arteriovenous Fistula Creation?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chronic kidney disease (CKD) describes abnormal kidney structure or function and is a significant public health problem. It is common, increasingly prevalent with age and often co-exists with significant morbidities, such as diabetes mellitus, hypertension, hyperlipidaemia, cerebrovascular disease and coronary artery disease. Patients with a diagnosis of CKD have a decreased life expectancy compared with individuals without this diagnosis. This is primarily due to cardiovascular disease, but other complications of CKD include bone and mineral disorders, anaemia, depression, and malnutrition. Early recognition and treatment of these complications is recommended.
In a proportion of patients, CKD will progress to end stage renal disease (ESRD). This is defined as an irreversible decline in kidney function for which renal replacement therapy (RRT) is required if the patient is to survive. In one UK study, 4% of patients with CKD progressed to develop ESRD requiring RRT over a five and a half year follow up period. The decision to commence RRT takes into account symptoms of biochemical disturbance, in conjunction with the risks and inconvenience of starting RRT. European Best Practice Guidelines recommend that RRT should commence when the estimated Glomerular Filtration Rate (eGFR) falls below 15ml/min/1.73m2 or when symptoms of uraemia, fluid overload or malnutrition are resistant to medical therapy. In an asymptomatic patient, an eGFR of below 6ml/min/1.73m2 would also prompt the initiation of dialysis. It is known that the life expectancy of patients receiving RRT is shorter than that of the general population and varies further dependent on underlying diagnosis and age. For example, the median survival for a patient in Scotland aged 45 - 64 years starting RRT for glomerulonephritis is 7.7 years, whereas the median survival of a patient in the same age group with a diagnosis of diabetic nephropathy is 2.9 years. The life expectancy of a male of the same age group within the general Scottish population is 24.2 years. Instituting RRT prolongs life and reduces the incidence of vasculo-occlusive events in patients with ESRD. As such, patients with CKD should be monitored by a nephrologist in order that timely referral for preparation for RRT can be made.
Renal replacement therapy may come in the form of haemodialysis, peritoneal dialysis or renal transplantation, and may be managed both in and out of hospital. Haemodialysis (HD) remains the most common modality of first RRT in Scotland; of 2885 patients commencing RRT during the period 2005-2009, 2264 received HD. In order to undergo HD, there must be a connection between the patient's vascular system and the dialysis machine. The most common method is surgical creation of an arteriovenous fistula (AVF), into which a needle can be inserted that in turn is connected to a dialysis machine. In 2009, 75% of Scottish patients undergoing HD underwent formation of an arteriovenous fistula (AVF). Other options for vascular access include arteriovenous grafts using synthetic materials and long-term central venous catheters, though these are associated with higher rates of occlusive and infective complications. AVF are currently regarded as the optimal form of vascular access for HD and are recommended by National guidelines. There is excellent evidence that good quality, stable vascular access is a major factor in determining survival in this group of CKD patients. Unfortunately however, around 24% - 35% of arteriovenous fistulae (AVF) fail at an early stage. Some anaesthetic techniques can influence intraoperative blood flow and venous diameter, factors which are associated with fistula success. There remains no conclusive evidence that any particular anaesthetic technique can significantly influence long term surgical outcome. This study aims to investigate whether a regional, compared to local, anaesthetic technique can affect fistula patency.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marc Clancy, MBBS PhD
- Phone Number: 0141 211 1750
- Email: Marc.Clancy@ggc.scot.nhs.uk
Study Contact Backup
- Name: Emma Aitken, MBChB MRCS
- Phone Number: 0141 211 1750
- Email: Emma.Aitken@nhs.net
Study Locations
-
-
-
Glasgow, United Kingdom, G116NY
- Recruiting
- Department of Renal Surgery, Western Infirmary
-
Contact:
- Marc Clancy, MBBS PhD FRCS
- Phone Number: 0141 211 1750
- Email: Marc.Clancy@ggc.scot.nhs.uk
-
Contact:
- Emma Aitken, MBChB MRCS
- Phone Number: 0141 211 1750
- Email: EmmaAitken@nhs.net
-
Principal Investigator:
- Marc Clancy, MBBS FRCS
-
Sub-Investigator:
- Alan McFarlane, MBChB FRCA
-
Sub-Investigator:
- Rachel Kearns, MBChB FRCA
-
Sub-Investigator:
- Emma Aitken, MBChB MRCS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- English-speaking
- Adult patients >18 years old
- Competent to give consent
- Scheduled for primary AVF formation at either radial or brachial artery.
Exclusion Criteria:
- Allergy to local anaesthetic.
- Coagulopathy
- Infection at the anaesthetic or surgical site.
- Patient preference for general or alternative anaesthesia
- Significant peripheral neuropathy or neurologic disorder affecting the upper extremity
- Pregnancy
- Previous AVF creation
- Known cephalic vein occlusion, central vein stenosis, brachial or radial artery stenosis
- Vein or artery less than 1.8mm, as measured by ultrasound
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Local anaesthetic
Infiltration of local anaesthetic into the surgical site by the surgeon using a combination of 0.5% L-bupivicaine prior to incision and 1% lignocaine topically after the wound is opened.
Maximum dose limits of 2mg/kg for bupivicaine, and 3mg/kg for lignocaine will be observed, recognising that these are additive.
|
Infiltration of local anaesthetic into the surgical site by the surgeon using a combination of 0.5% L-bupivicaine prior to incision and 1% lignocaine topically after the wound is opened.
Maximum dose limits of 2mg/kg for bupivicaine, and 3mg/kg for lignocaine will be observed, recognising that these are additive.
|
Experimental: Regional anaesthetic
Ultrasound guided brachial plexus block.
Supraclavicular will be the block performed unless there is a contraindication in which case axillary block may be used.
A 1:1 mixture of 0.5% L-bupivicaine and 1.5% lignocaine with adrenaline (1 in 200,000) will be injected, up to a volume of 40ml but using a minimum of 25ml.
Maximum dose limits of 2mg for bupivicaine and 7mg/kg for lignocaine with adrenaline will be observed, recognising that these are additive.
|
Ultrasound guided brachial plexus block.
Supraclavicular will be the block performed unless there is a contraindication in which case axillary block may be used.
A 1:1 mixture of 0.5% L-bupivicaine and 1.5% lignocaine with adrenaline (1 in 200,000) will be injected, up to a volume of 40ml but using a minimum of 25ml.
Maximum dose limits of 2mg for bupivicaine and 7mg/kg for lignocaine with adrenaline will be observed, recognising that these are additive.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary patency
Time Frame: 3 months
|
Primary patency defined as unequivocal maturation to permit cannulation with thrill and bruit without intervention (Y/N)
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient satisfaction
Time Frame: 24 hours
|
24 hours
|
|
Immediate Patency
Time Frame: 1 hours post-operatively
|
Defined as the unequivocal presence of thrill and bruit in the fistula in recovery room 1 hour post-opertaively (Y/N)
|
1 hours post-operatively
|
Primary patency
Time Frame: 1 month, 1year
|
Defined as the unequivoval presence of a thrill/ bruit at 1 month/ 1 year (Y/N)
|
1 month, 1year
|
Functional patency
Time Frame: 1, 3 and 12 months
|
Defined as a fistula capable of sustaining two needles haemodialysis for at least 6 consecutive sessions without intervention(Y/N)
|
1, 3 and 12 months
|
Secondary patency
Time Frame: 3 and 12 months
|
Defined as a fistula suitable to sustain haemodialysis only after additional intervention (e.g.
revisional surgery/ angioplasty)
|
3 and 12 months
|
Ultrasound flows in brachial artery
Time Frame: Pre-/post anaesthetic, 1, 3 and 12 months
|
Pre-/post anaesthetic, 1, 3 and 12 months
|
|
Success of anaesthetic
Time Frame: Immediate
|
Complications and efficacy (VAS for pain)
|
Immediate
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marc Clancy, MBBS FRCS, NHS Greater Glasgow and Clyde
Publications and helpful links
General Publications
- Aitken E, Kearns R, Gaianu L, Jackson A, Steven M, Kinsella J, Clancy M, Macfarlane A. Long-Term Functional Patency and Cost-Effectiveness of Arteriovenous Fistula Creation under Regional Anesthesia: a Randomized Controlled Trial. J Am Soc Nephrol. 2020 Aug;31(8):1871-1882. doi: 10.1681/ASN.2019111209. Epub 2020 Jul 24.
- Aitken E, Jackson A, Kearns R, Steven M, Kinsella J, Clancy M, Macfarlane A. Effect of regional versus local anaesthesia on outcome after arteriovenous fistula creation: a randomised controlled trial. Lancet. 2016 Sep 10;388(10049):1067-1074. doi: 10.1016/S0140-6736(16)30948-5. Epub 2016 Aug 1.
- Macfarlane AJ, Kearns RJ, Aitken E, Kinsella J, Clancy MJ. Does regional compared to local anaesthesia influence outcome after arteriovenous fistula creation? Trials. 2013 Aug 19;14:263. doi: 10.1186/1745-6215-14-263.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Urologic Diseases
- Congenital Abnormalities
- Renal Insufficiency
- Pathological Conditions, Anatomical
- Renal Insufficiency, Chronic
- Cardiovascular Abnormalities
- Vascular Malformations
- Arteriovenous Malformations
- Vascular Fistula
- Kidney Diseases
- Kidney Failure, Chronic
- Fistula
- Arteriovenous Fistula
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anesthetics, Local
Other Study ID Numbers
- 12/WS/0199
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.
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