Arteriovenous Fistulae, Neuropathic Pain
Conditions
Keywords
Neuropathic pain, Arteriovenous fistulae, End stage renal disease
Brief summary
Arteriovenous fistulae are artificial connections between the artery and vein in the arm which allow needles to be inserted for haemodialysising patients wit kidney 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.
Interventions
DRUGQutenza
Transdermal patch
Sponsors
NHS Greater Glasgow and Clyde
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuropathic pain | 12weeks | As assessed by Visual Analogue Pain Score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuropathic pain | 1 week, 6 weeks | As assessed by Visual Analogue Pain Score and Brief Pain Inventory |
| Quality of life | 6 weeks, 12 weeks | As assessed by EQ-5D |
| Safety and tolerability | 1 week, 6 weeks and 12 weeks | As assessed by: Number of adverse reactions. |
Countries
United Kingdom
Contacts
Primary ContactMarc Clancy, PhD FRCS
Backup ContactPatrick K Kearns, MBChB
Outcome results
None listed