Clinical trial NCT01748435: Pre-emptive Analgesia With Qutenza in Lower Limb Amputation
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neuropathic Pain
Lower Limb Amputation
Keywords: Neuropathic pain
Lower limb amputation
Pre-emptive analgesia
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
First posted: 2012-12-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing lower limb amputation

Brief 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.


Eligibility 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

Primary outcomes:
measure: Chronic neuropathic pain
timeFrame: 12 weeks
Secondary outcomes:
measure: Neuropathic pain
timeFrame: 1 weeks, 6 weeks, 12 weeks
measure: Acute post-operative pain
timeFrame: Day 1, 3, 7
measure: Wound healing
timeFrame: 1 week
measure: Quality of life
timeFrame: 12 weeks
measure: Safety and tolerability
timeFrame: 1 day, 12 weeks
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Western Infirmary
state: Lanarkshire
Study officials:
affiliation: NHS Greater Glasgow and Clyde
name: Emma L Aitken, MBChB
role: PRINCIPAL_INVESTIGATOR
References: