Ultrasound Guided Ankle Block Versus Medial Forefoot Block for Forefoot Surgery

Study Overview
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Brief Summary
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Forefoot surgery includes bunion surgery and similar reconstructive bone cutting surgery and is very painful. Local anaesthetic nerve blocks have been used for many years to help alleviate pain following this surgery. The present study aims to compare a new ultrasound guided nerve block to a well established nerve stimulator guided technique. Comparisons will include time taken to carry out the block, speed of onset of numbness and duration and quality of pain relief after surgery.

Official Title
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A Randomised, Blinded Comparison of an Ultrasound Guided Ankle Block Compared to a Nerve Stimulator Guided Ankle Block for Pain Relief After Forefoot Surgery.

Conditions
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Pain Relief After Forefoot Surgery

Intervention / Treatment
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* Procedure: Ultrasound guided ankle block
* Procedure: Medial forefoot block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fit adult patients requiring forefoot surgery with bone cutting. Exclusion Criteria: Morbid obesity (BMI >40), known contraindications to regional anaesthesia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasound guided ankle block<br>Subjects in this arm will be given an ultrasound guided ankle block prior to foot surgery. | Procedure: Ultrasound guided ankle block<br>* Under ultrasound guidance, block of the tibial nerve, superficial and deep branches of the common peroneal nerve and saphenous nerves will be carried out using 12 mls 0.5% levobupivacaine and 12 mls 0.75% levobupivacaine.<br>|
| Active Comparator: Medial forefoot block<br>Subjects in this arm will be given a nerve-stimulator guided forefoot block prior to anaesthesia and forefoot surgery | Procedure: Medial forefoot block<br>* Using peripheral nerve stimulator guidance, the tibial and common peroneal nerves will be blocked ( plus the saphenous nerve ), using a total of 12 mls 0.75% levobupivacaine and 12 mls 0.5% levobupivacaine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time taken to carry out each local anaesthetic block | Time taken between opening sterile packs and completion of local anaesthetic block is measured by a blind observer. | Over forty five minutes from the start of the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of local anaesthesia | Following administration of the local block, development of anaesthesia will be measured looking at cold and pin-prick sensation by a blind observer. | Over thirty minutes from completion of the local anaesthetic block. | 
| Duration of pain relief following local anaesthetic block. | Pain relief will be assessed over 24 hours following surgery, to assess its duration and quality, by a blind observer. | Over 24 hours following surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anaesthetic techniques, regional; surgery orthopaedic