Pre-emptive Analgesia With Qutenza in Lower Limb Amputation

Study Overview
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Brief Summary
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Neuropathic (nerve pain) following amputation of a limb is very common, affecting 60-80% of patients (Sherman et al, 1984). It can prolong their recovery making it difficult to fit protheses and mobilise. Current treatment options are limited and existing painkillers have significant side effects. Nevertheless there is some evidence that pre-emptive analgesia (pain relief provided prior to the surgery) has additional benefits after the surgery (Ypsilantis & Tang, 2010) Qutenza (topical capsaicin 8%)is a novel analgesic agent which is applied directly onto the skin. It works by desensitising to pain receptors in the skin (Nolano et al., 1999) and has been shown to be effective in reducing neuropathic pain in other conditions (Backonja et al., 2008) We propose to evaluate the use of Qutenza for pre-emptive analgesia in patients undergoing amputation of a limb. This is a small, pilot, randomised controlled study of 30 patients undergoing lower limb amputation who will have Qutenza or active control applied prior to surgery. They will be followed up for 12 weeks post-operatively with regular assessment of pain scores, quality of life and wound healing.

Official Title
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The Role of Pre-emptive Analgesia With Qutenza (Topical Capsaicin 8%) in Preventing Neuropathic Pain Following Lower Limb Amputation: a Pilot Randomised Controlled Study

Conditions
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Neuropathic Pain, Lower Limb Amputation

Intervention / Treatment
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* Drug: Qutenza


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adult patients >18 years old undergoing lower limb amputation Exclusion Criteria: Traumatic amputation Severe active sepsis in non-viable limb Illness necessitating urgent surgery <24 hours after admission to hospital 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Qutenza<br>Single treatment with QUTENZA (topical capsaicin 8%) transdermal patch | Drug: Qutenza<br>* Single treatment with Qutenza<br>* Other names: Qutenza (topical capsaicin 8%);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic neuropathic pain | Chronic neuropathic pain as assessed by Visual Analogue Pain Score | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropathic pain | Assessed using VAS and Brief Pain Inventory | 1 weeks, 6 weeks, 12 weeks | 
| Acute post-operative pain | Assessed by Visual Analogue Pain Score | Day 1, 3, 7 | 
| Wound healing | Assessed using standardised, validated wound healing tools | 1 week | 
| Quality of life | Assessed by EQ-5D | 12 weeks | 
| Safety and tolerability | Skin will be assessed for breaks/ blisters and tolerability including the need for rescue analgesia will be recorded | 1 day, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuropathic pain, Lower limb amputation, Pre-emptive analgesia