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Local Anaesthesia vs Regional Block for Arteriovenous Fistulae

Primary Purpose

End Stage Renal Disease

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Local Anaesthetic
Regional anaesthetic
Sponsored by
Emma Aitken
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring end stage renal disease, vascular access, regional anaesthesia

Eligibility Criteria

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

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

Sites / Locations

  • Department of Renal Surgery, Western InfirmaryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Local anaesthetic

Regional anaesthetic

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Primary patency
Primary patency defined as unequivocal maturation to permit cannulation with thrill and bruit without intervention (Y/N)

Secondary Outcome Measures

Immediate Patency
Defined as the unequivocal presence of thrill and bruit in the fistula in recovery room 1 hour post-opertaively (Y/N)
Primary patency
Defined as the unequivoval presence of a thrill/ bruit at 1 month/ 1 year (Y/N)
Functional patency
Defined as a fistula capable of sustaining two needles haemodialysis for at least 6 consecutive sessions without intervention(Y/N)
Secondary patency
Defined as a fistula suitable to sustain haemodialysis only after additional intervention (e.g. revisional surgery/ angioplasty)
Ultrasound flows in brachial artery
Patient satisfaction
Success of anaesthetic
Complications and efficacy (VAS for pain)

Full Information

First Posted
October 3, 2012
Last Updated
October 11, 2012
Sponsor
Emma Aitken
Collaborators
NHS Greater Glasgow and Clyde
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1. Study Identification

Unique Protocol Identification Number
NCT01706354
Brief Title
Local Anaesthesia vs Regional Block for Arteriovenous Fistulae
Official Title
Does Regional Compared to Local Anaesthesia Influence Outcome After Arteriovenous Fistula Creation?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Emma Aitken
Collaborators
NHS Greater Glasgow and Clyde

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
End stage renal failure (ESRF)describes an irreversible loss in renal function. The majority of these patients will opt for haemodialysis (HD)as their chosen method of renal replacement therapy (RRT). Arteriovenous fistulae (AVF) are the optimal method of achieving vascular access to permit HD. AVF are created with a small surgical procdure to join the artery and vein together. Over the next 6- 8weeks after surgery the AVF should grow ("mature") into a vessel suitable for needles to be inserted for dialysis. Unfortunately however, around 24% - 35% of 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
end stage renal disease, vascular access, regional anaesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Local anaesthetic
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Regional anaesthetic
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Local Anaesthetic
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Regional anaesthetic
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary patency
Description
Primary patency defined as unequivocal maturation to permit cannulation with thrill and bruit without intervention (Y/N)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Immediate Patency
Description
Defined as the unequivocal presence of thrill and bruit in the fistula in recovery room 1 hour post-opertaively (Y/N)
Time Frame
1 hours post-operatively
Title
Primary patency
Description
Defined as the unequivoval presence of a thrill/ bruit at 1 month/ 1 year (Y/N)
Time Frame
1 month, 1year
Title
Functional patency
Description
Defined as a fistula capable of sustaining two needles haemodialysis for at least 6 consecutive sessions without intervention(Y/N)
Time Frame
1, 3 and 12 months
Title
Secondary patency
Description
Defined as a fistula suitable to sustain haemodialysis only after additional intervention (e.g. revisional surgery/ angioplasty)
Time Frame
3 and 12 months
Title
Ultrasound flows in brachial artery
Time Frame
Pre-/post anaesthetic, 1, 3 and 12 months
Title
Patient satisfaction
Time Frame
24 hours
Title
Success of anaesthetic
Description
Complications and efficacy (VAS for pain)
Time Frame
Immediate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc Clancy, MBBS PhD
Phone
0141 211 1750
Email
Marc.Clancy@ggc.scot.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Emma Aitken, MBChB MRCS
Phone
0141 211 1750
Email
Emma.Aitken@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Clancy, MBBS FRCS
Organizational Affiliation
NHS Greater Glasgow and Clyde
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Renal Surgery, Western Infirmary
City
Glasgow
ZIP/Postal Code
G116NY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Clancy, MBBS PhD FRCS
Phone
0141 211 1750
Email
Marc.Clancy@ggc.scot.nhs.uk
First Name & Middle Initial & Last Name & Degree
Emma Aitken, MBChB MRCS
Phone
0141 211 1750
Email
EmmaAitken@nhs.net
First Name & Middle Initial & Last Name & Degree
Marc Clancy, MBBS FRCS
First Name & Middle Initial & Last Name & Degree
Alan McFarlane, MBChB FRCA
First Name & Middle Initial & Last Name & Degree
Rachel Kearns, MBChB FRCA
First Name & Middle Initial & Last Name & Degree
Emma Aitken, MBChB MRCS

12. IPD Sharing Statement

Citations:
PubMed Identifier
32709710
Citation
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.
Results Reference
derived
PubMed Identifier
27492881
Citation
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.
Results Reference
derived
PubMed Identifier
23958289
Citation
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.
Results Reference
derived

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Local Anaesthesia vs Regional Block for Arteriovenous Fistulae

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