Qutenza for Painful Fistulae

Condition(s) targeted: Neuropathic Pain; Arteriovenous Fistulae

Intervention: Qutenza (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: NHS Greater Glasgow and Clyde

Official(s) and/or principal investigator(s):
Marc Clancy, FRCS PhD, Principal Investigator, Affiliation: NHS Greater Glasgow and Clyde

Overall contact:
Marc Clancy, PhD FRCS, Phone: 01412111750, Email: Marc.Clancy@ggc.scot.nhs.uk

Arteriovenous fistulae are artificial connections between the artery and vein in the arm which allow needles to be inserted for haemodialysisin patients wit hkidney failure. Occasionally severe debilitating pain can arise from these fistulae for which no cause can be found. Such pain can be very difficult to treat. Many commonly used used painkillers are known to cause significant side effects in patients with renal failure (drowsiness, confusion etc. Qutenza (topical capsaicin 8%) is a new treatment made from chilli peppers which is applied to the skin as a patch and works directly at the nerve endings in the skin to prevent pain. It therefore should not have the systemic side effects of other drugs. It has been demonstrated to be beneficial in other painful conditions for example post-shingles pain and nerve pain from HIV. It has never been used for critical ischaemia before. We propose to investigate the efficacy of Qutenza in treating patients with end stage renal failure and chronic pain from their fistulae (AVF). We will recruit 20 patients with painful AVF and treat them with Qutenza. We will follow them up for 12 weeks and monitor the change in their pain scores.

Official title: The Role of Qutenza (Topical Capsaicin 8%) in Treating Neuropathic Pain From Arteriovenous Fistulae in Patients With End Stage Renal Failure

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Neuropathic pain

Secondary outcome:

Neuropathic pain

Qulaity of life

Safety and tolerability

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- All adult patients >18 years old with end stage renal disease on dialysis and

significant chronic neuropathic pain arising from their arteriovenous fistula (defined as pain with symptoms to suggest a neuropathic element occurring most days for at least a month which has not responded to simple analgesia) Exclusion Criteria: Pre-dialysis Underlying anatomical/ structural abnormality with AVF contributing to pain Diabetic neuropathy resulting in sensory loss Hypersensitivity to Qutenza, Emla or any of the excipients Broken skin or active ulceration at the site of application Severe uncontrolled hypertension (systolic BP >200) Proven cardiac event during the preceding 3 months Women who are pregnant or breast feeding Lack of capacity or inability to provide informed consent Declines participation in the study

Marc Clancy, PhD FRCS, Phone: 01412111750, Email: Marc.Clancy@ggc.scot.nhs.uk

Department of Renal Surgery, Western Infirmary, Glasgow, Lanarkshire G116NY, United Kingdom; Not yet recruiting
Marc Clancy, FRCS PhD, Phone: 01412111750, Email: Marc.Clancy@ggc.scot.nhs.uk
Emma L Aitken, MBChB, Phone: 01412111750, Email: EmmaAitken@nhs.net
Marc Clancy, FRCS PhD, Principal Investigator

Starting date: April 2013
Last updated: December 10, 2012