Pre-emptive Analgesia With Qutenza in Lower Limb Amputation

• Conditions: Neuropathic Pain; Lower Limb Amputation
• Interventions: Drug: Qutenza

• Registration Number: NCT01748435
• Lead Sponsor: NHS Greater Glasgow and Clyde

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-12
• Study First Submitted: 2012-12-10
• Study First Submitted QC: 2012-12-10
• Last Update Submitted: 2012-12-10
• Study First Posted: 2012-12-12
• Last Update Posted: 2012-12-12
• Study Start: 2013-02
• Primary Completion: 2014-02
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Qutenza	Qutenza	Single treatment with QUTENZA (topical capsaicin 8%) transdermal patch

Primary Outcome Measures

Name	Time	Method
Chronic neuropathic pain	12 weeks	Chronic neuropathic pain as assessed by Visual Analogue Pain Score

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Western Infirmary; 🇬🇧 Glasgow, Lanarkshire, United Kingdom