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Pre-emptive Analgesia With Qutenza in Lower Limb Amputation

This study is not yet open for participant recruitment.
Verified December 2012 by NHS Greater Glasgow and Clyde
Sponsor:
Information provided by (Responsible Party):
Emma Aitken, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier:
NCT01748435
First received: December 10, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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:

Drug Information available for: Capsaicin
U.S. FDA Resources

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

Primary Outcome Measures:
  • Chronic neuropathic pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Chronic neuropathic pain as assessed by Visual Analogue Pain Score


Secondary Outcome Measures:
  • Neuropathic pain [ Time Frame: 1 weeks, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
    Assessed using VAS and Brief Pain Inventory

  • Acute post-operative pain [ Time Frame: Day 1, 3, 7 ] [ Designated as safety issue: No ]
    Assessed by Visual Analogue Pain Score

  • Wound healing [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    Assessed using standardised, validated wound healing tools

  • Quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Assessed by EQ-5D

  • Safety and tolerability [ Time Frame: 1 day, 12 weeks ] [ Designated as safety issue: Yes ]
    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
Qutenza
Single treatment with QUTENZA (topical capsaicin 8%) transdermal patch
 Drug: Qutenza
Single treatment with Qutenza
Other Name: Qutenza (topical capsaicin 8%)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients undergoing lower limb amputation

Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748435

Contacts
Contact: Emma L Aitken, MBChB 01412111750 EmmaAitken@nhs.net
Contact: David B Kingsmore, MBChB MD 01412111750 david.kingsmore@ggc.scot.nhs.uk

Locations
United Kingdom
Western Infirmary Not yet recruiting
Glasgow, Lanarkshire, United Kingdom, G116NY
Contact: Emma L Aitken, MBChB     01412111750     EmmaAitken@nhs.net    
Contact: David B Kingsmore, MBChB MD     01412111750     david.kingsmore@ggc.scot.nhs.uk    
Principal Investigator: Emma L Aitken, MBChB            
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
Investigators
Principal Investigator: Emma L Aitken, MBChB NHS Greater Glasgow and Clyde
  More Information

No publications provided

Responsible Party: Emma Aitken, Clinical Resrach Fellow, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT01748435     History of Changes
Other Study ID Numbers: GU11SU387, 2012-001587-30
Study First Received: December 10, 2012
Last Updated: December 10, 2012
Health Authority: United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Capsaicin
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antipruritics
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013