Pre-emptive Analgesia With Qutenza in Lower Limb Amputation

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

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.

Study Overview

• Status: Unknown
• Conditions: Neuropathic Pain; Lower Limb Amputation
• Intervention / Treatment: Drug: Qutenza

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: David B Kingsmore, MBChB MD; Phone Number: 01412111750; Email: david.kingsmore@ggc.scot.nhs.uk

Study Locations

• United Kingdom
  • Lanarkshire
    • Glasgow, Lanarkshire, United Kingdom, G116NY
      • Western Infirmary
      • Principal Investigator: Emma L Aitken, MBChB
      • Contact: David B Kingsmore, MBChB MD; Phone Number: 01412111750; Email: david.kingsmore@ggc.scot.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing lower limb amputation

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Qutenza; Single treatment with QUTENZA (topical capsaicin 8%) transdermal patch	Drug: Qutenza; Single treatment with Qutenza; Other Names: Qutenza (topical capsaicin 8%)

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Investigators: Principal Investigator: Emma L Aitken, MBChB, NHS Greater Glasgow and Clyde

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Anticipated): February 1, 2014
• Study Completion (Anticipated): May 1, 2014

Study Registration Dates

• First Submitted: December 10, 2012
• First Submitted That Met QC Criteria: December 10, 2012
• First Posted (Estimate): December 12, 2012

Study Record Updates

• Last Update Posted (Estimate): December 12, 2012
• Last Update Submitted That Met QC Criteria: December 10, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Neuropathic pain; Lower limb amputation; Pre-emptive analgesia
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Dermatologic Agents; Antipruritics; Capsaicin
• Other Study ID Numbers: GU11SU387; 2012-001587-30 (EudraCT Number)