Qutenza for Painful Fistulae
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Neuropathic Pain Arteriovenous Fistulae |
Drug: Qutenza |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Role of Qutenza (Topical Capsaicin 8%) in Treating Neuropathic Pain From Arteriovenous Fistulae in Patients With End Stage Renal Failure |
- Neuropathic pain [ Time Frame: 12weeks ] [ Designated as safety issue: No ]As assessed by Visual Analogue Pain Score
- Neuropathic pain [ Time Frame: 1 week, 6 weeks ] [ Designated as safety issue: No ]As assessed by Visual Analogue Pain Score and Brief Pain Inventory
- Qulaity of life [ Time Frame: 6 weeks, 12 weeks ] [ Designated as safety issue: No ]As assessed by EQ-5D
- Safety and tolerability [ Time Frame: 1 week, 6 weeks and 12 weeks ] [ Designated as safety issue: Yes ]Skin will be assessed for breaks/ blisters and tolerability, including the need for rescue analgesia will be recorded
| Estimated Enrollment: | 20 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Experimental: Qutenza
Single treatment with Qutenza (topical capsaicin8%) transdermal patch
|
Drug: Qutenza
Transdermal patch
Other Name: Topical capsaicin 8%
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with end stage renal failure and chronic neuroapthic pain arising fromt heir arteriovenous fistulae
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
Contacts and Locations| Contact: Marc Clancy, PhD FRCS | 01412111750 | Marc.Clancy@ggc.scot.nhs.uk |
| Contact: Emma L Aitken, MBChB | 01412111750 | EmmaAitken@nhs.net |
| United Kingdom | |
| Department of Renal Surgery, Western Infirmary | Not yet recruiting |
| Glasgow, Lanarkshire, United Kingdom, G116NY | |
| Contact: Marc Clancy, FRCS PhD 01412111750 Marc.Clancy@ggc.scot.nhs.uk | |
| Contact: Emma L Aitken, MBChB 01412111750 EmmaAitken@nhs.net | |
| Principal Investigator: Marc Clancy, FRCS PhD | |
| Principal Investigator: | Marc Clancy, FRCS PhD | NHS Greater Glasgow and Clyde |
More Information
No publications provided
| Responsible Party: | Emma Aitken, Clinical Research Fellow, NHS Greater Glasgow and Clyde |
| ClinicalTrials.gov Identifier: | NCT01748422 History of Changes |
| Other Study ID Numbers: | GU11SB126 |
| Study First Received: | December 10, 2012 |
| Last Updated: | December 10, 2012 |
| Health Authority: | UK: Research Ethics Committee |
Keywords provided by NHS Greater Glasgow and Clyde:
|
Neuropathic pain Arteriovenous fistulae End stage renal disease |
Additional relevant MeSH terms:
|
Arteriovenous Fistula Fistula Kidney Failure, Chronic Neuralgia Arteriovenous Malformations Vascular Malformations Cardiovascular Abnormalities Cardiovascular Diseases Vascular Fistula Vascular Diseases Congenital Abnormalities Pathological Conditions, Anatomical Renal Insufficiency, Chronic Renal Insufficiency Kidney Diseases |
Urologic Diseases Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Capsaicin Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Antipruritics Dermatologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013