Pre-emptive Analgesia With Qutenza in Lower Limb Amputation

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01748435
• Other study ID #: GU11SU387
• Secondary ID: 2012-001587-30
• Status: Not yet recruiting
• Phase: N/A
• First received: December 10, 2012
• Last updated: December 10, 2012
• Start date: February 2013
• Est. completion date: May 2014

Study information

• Verified date: December 2012
• Source: NHS Greater Glasgow and Clyde
• Contact: Emma L Aitken, MBChB
• Phone: 01412111750
• Email: EmmaAitken[@]nhs.net
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lower Limb Amputation
• Neuralgia
• Neuropathic Pain

Intervention

Drug:
• Qutenza
Single treatment with Qutenza

Locations

Country	Name	City	State
United Kingdom	Western Infirmary	Glasgow	Lanarkshire

Sponsors (1)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic neuropathic pain	Chronic neuropathic pain as assessed by Visual Analogue Pain Score	12 weeks	No
Secondary	Neuropathic pain	Assessed using VAS and Brief Pain Inventory	1 weeks, 6 weeks, 12 weeks	No
Secondary	Acute post-operative pain	Assessed by Visual Analogue Pain Score	Day 1, 3, 7	No
Secondary	Wound healing	Assessed using standardised, validated wound healing tools	1 week	Yes
Secondary	Quality of life	Assessed by EQ-5D	12 weeks	No
Secondary	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	Yes