Local Anaesthesia vs Regional Block for Arteriovenous Fistulae

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by NHS Greater Glasgow and Clyde
Sponsor:
Collaborator:
NHS Greater Glasgow and Clyde
Information provided by (Responsible Party):
Emma Aitken, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier:
NCT01706354
First received: October 3, 2012
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
End Stage Renal Disease
Procedure: Local Anaesthetic
Procedure: Regional anaesthetic

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Regional Compared to Local Anaesthesia Influence Outcome After Arteriovenous Fistula Creation?

Resource links provided by NLM:


Further study details as provided by NHS Greater Glasgow and Clyde:

Primary Outcome Measures:
  • Primary patency [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Primary patency defined as unequivocal maturation to permit cannulation with thrill and bruit without intervention (Y/N)


Secondary Outcome Measures:
  • Immediate Patency [ Time Frame: 1 hours post-operatively ] [ Designated as safety issue: No ]
    Defined as the unequivocal presence of thrill and bruit in the fistula in recovery room 1 hour post-opertaively (Y/N)

  • Primary patency [ Time Frame: 1 month, 1year ] [ Designated as safety issue: No ]
    Defined as the unequivoval presence of a thrill/ bruit at 1 month/ 1 year (Y/N)

  • Functional patency [ Time Frame: 1, 3 and 12 months ] [ Designated as safety issue: No ]
    Defined as a fistula capable of sustaining two needles haemodialysis for at least 6 consecutive sessions without intervention(Y/N)

  • Secondary patency [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
    Defined as a fistula suitable to sustain haemodialysis only after additional intervention (e.g. revisional surgery/ angioplasty)

  • Ultrasound flows in brachial artery [ Time Frame: Pre-/post anaesthetic, 1, 3 and 12 months ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Success of anaesthetic [ Time Frame: Immediate ] [ Designated as safety issue: Yes ]
    Complications and efficacy (VAS for pain)


Estimated Enrollment: 126
Study Start Date: October 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: 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.
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.
Procedure: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01706354

Contacts
Contact: Marc Clancy, MBBS PhD 0141 211 1750 Marc.Clancy@ggc.scot.nhs.uk
Contact: Emma Aitken, MBChB MRCS 0141 211 1750 Emma.Aitken@nhs.net

Locations
United Kingdom
Department of Renal Surgery, Western Infirmary Recruiting
Glasgow, United Kingdom, G116NY
Contact: Marc Clancy, MBBS PhD FRCS    0141 211 1750    Marc.Clancy@ggc.scot.nhs.uk   
Contact: Emma Aitken, MBChB MRCS    0141 211 1750    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         
Sponsors and Collaborators
Emma Aitken
NHS Greater Glasgow and Clyde
Investigators
Principal Investigator: Marc Clancy, MBBS FRCS NHS Greater Glasgow and Clyde
  More Information

No publications provided by NHS Greater Glasgow and Clyde

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Emma Aitken, Clinical Research Fellow Department of Renal Surgery, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT01706354     History of Changes
Other Study ID Numbers: 12/WS/0199
Study First Received: October 3, 2012
Last Updated: October 11, 2012
Health Authority: United Kingdom: National Health Service

Keywords provided by NHS Greater Glasgow and Clyde:
end stage renal disease
vascular access
regional anaesthesia

Additional relevant MeSH terms:
Anesthetics
Anesthetics, Local
Kidney Diseases
Kidney Failure, Chronic
Arteriovenous Fistula
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Fistula
Pathological Conditions, Anatomical
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014