MedDataX Logo

Pre-emptive Analgesia With Qutenza in Lower Limb Amputation

NCT ID: NCT01748435

Last Updated: 2012-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neuropathic Pain Lower Limb Amputation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Neuropathic pain Lower limb amputation Pre-emptive analgesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Qutenza

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

Qutenza

Intervention Type DRUG

Single treatment with Qutenza

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Qutenza

Single treatment with Qutenza

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Qutenza (topical capsaicin 8%)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Emma Aitken

Clinical Resrach Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Emma L Aitken, MBChB

Role: PRINCIPAL_INVESTIGATOR

NHS Greater Glasgow and Clyde

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Western Infirmary

Glasgow, Lanarkshire, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Emma L Aitken, MBChB

Role: CONTACT

Phone: 01412111750

Email: [email protected]

David B Kingsmore, MBChB MD

Role: CONTACT

Phone: 01412111750

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Emma L Aitken, MBChB

Role: primary

David B Kingsmore, MBChB MD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2012-001587-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GU11SU387

Identifier Type: -

Identifier Source: org_study_id