Neuropathic PainNCT01748435
Pre-emptive Analgesia With Qutenza in Lower Limb Amputation
An observational study of Neuropathic Pain and Lower Limb Amputation, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain, Lower Limb Amputation
- What is being tested?
- Qutenza
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2013to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing lower limb amputation
Who may be able to join
- All adult patients >18 years old undergoing lower limb amputation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Western Infirmary
Glasgow, Lanarkshire, G116NY
Emma L Aitken, MBChB, 01412111750, EmmaAitken@nhs.net
David B Kingsmore, MBChB MD, 01412111750, david.kingsmore@ggc.scot.nhs.uk
About this study
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
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
- Being tested
- Qutenza
- Keywords
- Neuropathic pain, Lower limb amputation, Pre-emptive analgesia
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QutenzaDrug
Also called Qutenza (topical capsaicin 8%)
Single treatment with Qutenza
| Study group | Role | What they receive |
|---|---|---|
| Qutenza | Single treatment with QUTENZA (topical capsaicin 8%) transdermal patch Receives: Drug: Qutenza |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic neuropathic pain
Chronic neuropathic pain as assessed by Visual Analogue Pain Score
Measured: 12 weeks
Secondary outcomes (5)
Neuropathic pain
Assessed using VAS and Brief Pain Inventory
Measured: 1 weeks, 6 weeks, 12 weeks
Acute post-operative pain
Assessed by Visual Analogue Pain Score
Measured: Day 1, 3, 7
Wound healing
Assessed using standardised, validated wound healing tools
Measured: 1 week
Quality of life
Assessed by EQ-5D
Measured: 12 weeks
Safety and tolerability
Skin will be assessed for breaks/ blisters and tolerability including the need for rescue analgesia will be recorded
Measured: 1 day, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startFeb 2013
- Primary completionFeb 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emma Aitken, NHS Greater Glasgow and Clyde
- Investigators
- Emma L Aitken, MBChB, Principal investigator, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748435
- Sponsor's protocol ID
- GU11SU387
- Other IDs
- 2012-001587-30
- Status last verified
- Dec 2012
- First submitted
- 10 Dec 2012
- Last updated
- 12 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01748435
- Acronym / sponsor ID
- GU11SU387
- Conditions
- Neuropathic Pain, Lower Limb Amputation
- Keywords
- Neuropathic pain, Lower limb amputation, Pre-emptive analgesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 12 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Qutenza | – | Drug: QutenzaSingle treatment with QUTENZA (topical capsaicin 8%) transdermal patch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing lower limb amputation
Key inclusion criteria (1 listed)
- All adult patients >18 years old undergoing lower limb amputation
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QutenzaAlso: Qutenza (topical capsaicin 8%)Single treatment with Qutenza | Drug | Qutenza |
Primary outcome
Chronic neuropathic pain
Time frame: 12 weeks
Chronic neuropathic pain as assessed by Visual Analogue Pain Score
5 secondary outcomes
Neuropathic pain
Time frame: 1 weeks, 6 weeks, 12 weeks
Acute post-operative pain
Time frame: Day 1, 3, 7
Wound healing
Time frame: 1 week
Quality of life
Time frame: 12 weeks
Safety and tolerability
Time frame: 1 day, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma L Aitken, MBChB principal investigator
NHS Greater Glasgow and Clyde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain and Lower Limb Amputation, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emma L Aitken, MBChB (01412111750, EmmaAitken@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic neuropathic pain (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2012.