Qutenza (Topical Capsaicin 8%) for Painful Arteriovenous Fistulae

• Conditions: Neuropathic Pain; Arteriovenous Fistulae
• Interventions: Drug: Qutenza

• Registration Number: NCT01748422
• Lead Sponsor: NHS Greater Glasgow and Clyde

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-10
• Study First Submitted QC: 2012-12-10
• Study First Posted: 2012-12-12
• Study Start: 2015-11
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-09
• Last Update Posted: 2016-11-11
• Primary Completion: 2017-08
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental: Qutenza	Qutenza	Single treatment with Qutenza (topical capsaicin8%) transdermal patch

Primary Outcome Measures

Name	Time	Method
Neuropathic pain	12weeks	As assessed by Visual Analogue Pain Score

Secondary Outcome Measures

Name	Time	Method
Neuropathic pain	1 week, 6 weeks	As assessed by Visual Analogue Pain Score and Brief Pain Inventory
Safety and tolerability	1 week, 6 weeks and 12 weeks	As assessed by: Number of adverse reactions.
Quality of life	6 weeks, 12 weeks	As assessed by EQ-5D

Trial Locations

Locations (1)

Department of Renal Surgery, Queen Elizabeth University Hospital; 🇬🇧 Glasgow, Lanarkshire, United Kingdom