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Pre-emptive Analgesia With Qutenza in Lower Limb Amputation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Emma Aitken, NHS Greater Glasgow and Clyde.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Emma Aitken, NHS Greater Glasgow and Clyde Identifier:
First received: December 10, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
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.

Condition Intervention
Neuropathic Pain
Lower Limb Amputation
Drug: Qutenza

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

Further study details as provided by Emma Aitken, NHS Greater Glasgow and Clyde:

Primary Outcome Measures:
  • Chronic neuropathic pain [ Time Frame: 12 weeks ]
    Chronic neuropathic pain as assessed by Visual Analogue Pain Score

Secondary Outcome Measures:
  • Neuropathic pain [ Time Frame: 1 weeks, 6 weeks, 12 weeks ]
    Assessed using VAS and Brief Pain Inventory

  • Acute post-operative pain [ Time Frame: Day 1, 3, 7 ]
    Assessed by Visual Analogue Pain Score

  • Wound healing [ Time Frame: 1 week ]
    Assessed using standardised, validated wound healing tools

  • Quality of life [ Time Frame: 12 weeks ]
    Assessed by EQ-5D

  • Safety and tolerability [ Time Frame: 1 day, 12 weeks ]
    Skin will be assessed for breaks/ blisters and tolerability including the need for rescue analgesia will be recorded

Estimated Enrollment: 30
Study Start Date: February 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Single treatment with QUTENZA (topical capsaicin 8%) transdermal patch
Drug: Qutenza
Single treatment with Qutenza
Other Name: Qutenza (topical capsaicin 8%)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients undergoing lower limb amputation

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

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Please refer to this study by its identifier: NCT01748435

Contact: Emma L Aitken, MBChB 01412111750
Contact: David B Kingsmore, MBChB MD 01412111750

United Kingdom
Western Infirmary Not yet recruiting
Glasgow, Lanarkshire, United Kingdom, G116NY
Contact: Emma L Aitken, MBChB    01412111750   
Contact: David B Kingsmore, MBChB MD    01412111750   
Principal Investigator: Emma L Aitken, MBChB         
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
Principal Investigator: Emma L Aitken, MBChB NHS Greater Glasgow and Clyde
  More Information

Responsible Party: Emma Aitken, Clinical Resrach Fellow, NHS Greater Glasgow and Clyde Identifier: NCT01748435     History of Changes
Other Study ID Numbers: GU11SU387
2012-001587-30 ( EudraCT Number )
Study First Received: December 10, 2012
Last Updated: December 10, 2012

Keywords provided by Emma Aitken, NHS Greater Glasgow and Clyde:
Neuropathic pain
Lower limb amputation
Pre-emptive analgesia

Additional relevant MeSH terms:
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs processed this record on May 25, 2017