NCT01706354

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 15, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 15, 2012

Status Verified

October 1, 2012

Enrollment Period

2 years

First QC Date

October 3, 2012

Last Update Submit

October 11, 2012

Conditions

End Stage Renal Disease

Keywords

end stage renal diseasevascular accessregional anaesthesia

Outcome Measures

Primary Outcomes (1)

  • Primary patency

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

    3 months

Secondary Outcomes (7)

  • Immediate Patency

    1 hours post-operatively

  • Primary patency

    1 month, 1year

  • Functional patency

    1, 3 and 12 months

  • Secondary patency

    3 and 12 months

  • Ultrasound flows in brachial artery

    Pre-/post anaesthetic, 1, 3 and 12 months

  • +2 more secondary outcomes

Study Arms (2)

Local anaesthetic

ACTIVE COMPARATOR

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

Regional anaesthetic

EXPERIMENTAL

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

Interventions

Local AnaestheticPROCEDURE

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.

Local anaesthetic
Regional anaestheticPROCEDURE

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.

Regional anaesthetic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English-speaking
  • Adult patients \>18 years old
  • Competent to give consent
  • Scheduled for primary AVF formation at either radial or brachial artery.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Renal Surgery, Western Infirmary

Glasgow, G116NY, United Kingdom

RECRUITING

Related Publications (3)

  • 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.

    PMID: 32709710DERIVED

  • 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.

    PMID: 27492881DERIVED

  • 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.

    PMID: 23958289DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Marc Clancy, MBBS FRCS

    NHS Greater Glasgow and Clyde

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Clancy, MBBS PhD

CONTACT

0141 211 1750Marc.Clancy@ggc.scot.nhs.uk

Emma Aitken, MBChB MRCS

CONTACT

0141 211 1750Emma.Aitken@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Research Fellow Department of Renal Surgery

Study Record Dates

First Submitted

October 3, 2012

First Posted

October 15, 2012

Study Start

October 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2015

Last Updated

October 15, 2012

Record last verified: 2012-10

Locations

GB(1)