NCT01748435

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: NHS Greater Glasgow and Clyde · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Qutenza	Single treatment with Qutenza

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-02-01
• Completion: 2014-05-01
• First posted: 2012-12-12
• Last updated: 2012-12-12

Locations

1 site across 1 country: United Kingdom