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Pre-emptive Analgesia With Qutenza in Lower Limb Amputation

NCT01748435 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2012-12-12

No results posted yet for this study

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.

Conditions

  • Neuropathic Pain
  • Lower Limb Amputation

Interventions

DRUG

Qutenza

Single treatment with Qutenza

Sponsors & Collaborators

  • NHS Greater Glasgow and Clyde

    lead OTHER

Principal Investigators

  • Emma L Aitken, MBChB · NHS Greater Glasgow and Clyde

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2014-02-28
Completion
2014-05-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01748435 on ClinicalTrials.gov