Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
69 participants
INTERVENTIONAL
2018-02-02
2019-06-30
Brief Summary
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Detailed Description
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The trial seeks to recruit 23 patients into either of 3 groups: Ankle + sham metatarsal; sham Ankle + metatarsal; Ankle + Metatarsal.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ankle + Sham metatarsal
Ankle block + sham metatarsal block
Ankle block
Ultrasound guided ankle block of the tibial, superficial peroneal and deep peroneal nerves will be performed using a standardised technique
Sham metatarsal block
In the supine position, after the surgical incision has been sutured, a 25G standard bevel needle will be placed against the skin at the points at which the practitioner would normally have performed insertions of the needle. It will remain there for a total of 30 seconds and then be removed.
Ankle + Metatarsal
Ankle block + metatarsal block
Ankle block
Ultrasound guided ankle block of the tibial, superficial peroneal and deep peroneal nerves will be performed using a standardised technique
Metatarsal block
A metatarsal block will be performed using a standardised technique
Metatarsal + sham ankle
Metatarsal block + sham ankle block
Sham ankle block
In the supine position with the hip and knee flexed, and the hip externally rotated, the skin from medial malleolus to Achilles tendon will be prepared with chlorhexidine 0.5% solution and allowed to dry. An ultrasound probe (linear array HFL25, Sonosite, Hitchin, UK) will be placed on a line from medial malleolus to achilles tendon to identify the posterior tibial artery and tibial nerve. A Stimuplex A50 needle (B-Braun) will be placed against the skin at the point at which the practitioner would normally have performed insertion of the needle. It will remain there for a total of 30 seconds and then will be removed.
Metatarsal block
A metatarsal block will be performed using a standardised technique
Interventions
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Ankle block
Ultrasound guided ankle block of the tibial, superficial peroneal and deep peroneal nerves will be performed using a standardised technique
Sham ankle block
In the supine position with the hip and knee flexed, and the hip externally rotated, the skin from medial malleolus to Achilles tendon will be prepared with chlorhexidine 0.5% solution and allowed to dry. An ultrasound probe (linear array HFL25, Sonosite, Hitchin, UK) will be placed on a line from medial malleolus to achilles tendon to identify the posterior tibial artery and tibial nerve. A Stimuplex A50 needle (B-Braun) will be placed against the skin at the point at which the practitioner would normally have performed insertion of the needle. It will remain there for a total of 30 seconds and then will be removed.
Metatarsal block
A metatarsal block will be performed using a standardised technique
Sham metatarsal block
In the supine position, after the surgical incision has been sutured, a 25G standard bevel needle will be placed against the skin at the points at which the practitioner would normally have performed insertions of the needle. It will remain there for a total of 30 seconds and then be removed.
Eligibility Criteria
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Inclusion Criteria
* Male or female, aged 18 years or above.
* Diagnosed with 1st metatarsal pathology requiring surgical correction
* Participant meets the criteria for operative management in our day-surgery unit
Exclusion Criteria
* Diabetic neuropathy affecting lower limbs
* Peripheral neuropathy affecting lower limbs of any aetiology
* Revision surgery
* Lack of capacity to consent
18 Years
ALL
No
Sponsors
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Queen Elizabeth Hospital NHS Foundation Trust
OTHER
Responsible Party
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Dr James Stimpson
Consultant Anaesthetist
Locations
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Queen Elizabeth Hospital NHS Trust
Kings Lynn, Norfolk, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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JSCP1
Identifier Type: -
Identifier Source: org_study_id
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