Pre-emptive Analgesia With Qutenza in Lower Limb Amputation

NCT01748435 | Unknown

• 2 other identifiers: GU11SU3872012-001587-30
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain; Lower Limb Amputation

Keywords

Neuropathic pain; Lower limb amputation; Pre-emptive analgesia

Outcome Measures

Primary Outcomes (1)

• Chronic neuropathic pain

  Chronic neuropathic pain as assessed by Visual Analogue Pain Score

  12 weeks

Secondary Outcomes (5)

• Neuropathic pain

  1 weeks, 6 weeks, 12 weeks

• Acute post-operative pain

  Day 1, 3, 7

• Wound healing

  1 week

• Quality of life

  12 weeks

• Safety and tolerability

  1 day, 12 weeks

Study Arms (1)

Qutenza

Single treatment with QUTENZA (topical capsaicin 8%) transdermal patch

Drug: Qutenza

Interventions

Qutenza DRUG

Single treatment with Qutenza

Also known as: Qutenza (topical capsaicin 8%)

Qutenza

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing lower limb amputation

You may qualify if:

• All adult patients \>18 years old undergoing lower limb amputation

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead

Study Sites (1)

Western Infirmary

Glasgow, Lanarkshire, G116NY, United Kingdom

Location

MeSH Terms

Conditions

Neuralgia

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Emma L Aitken, MBChB

  NHS Greater Glasgow and Clyde

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma L Aitken, MBChB

CONTACT

01412111750; EmmaAitken@nhs.net

David B Kingsmore, MBChB MD

CONTACT

01412111750; david.kingsmore@ggc.scot.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Resrach Fellow

Study Record Dates

• First Submitted: December 10, 2012
• First Posted: December 12, 2012
• Study Start: February 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 12, 2012

Record last verified: 2012-12

Locations

GB (1)