Optimal Analgesia for Forefoot Surgery

Study Overview
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Brief Summary
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A randomised trial comparing three analgesic strategies for patients undergoing forefoot surgery in a day-surgery setting.

Detailed Description
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Forefoot surgery, including Scarf-Akin osteotomy surgery for bunion correction, is moderately painful orthopaedic surgery, commonly performed as a day-case procedure. Admission for opiate analgesia constitutes a failure of management and financial disadvantage to the healthcare organisation. The investigators seek to establish which technique will result in the best analgesia out of ankle block, metatarsal block, or a combination of the two. As analgesia constitutes part of a return to function, an additional aim is to determine whether either of these approaches will result in an objective functional benefit to the participants. The trial seeks to recruit 23 patients into either of 3 groups: Ankle + sham metatarsal; sham Ankle + metatarsal; Ankle + Metatarsal.

Official Title
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Optimal Analgesia Following Metatarsal Surgery: A Prospective Randomised, Single-Blind Sham-Controlled Trial of Three Strategies

Conditions
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Hallux Valgus, Conduction Block

Intervention / Treatment
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* Procedure: Ankle block
* Procedure: Sham ankle block
* Procedure: Metatarsal block
* Procedure: Sham metatarsal block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is willing and able to give informed consent for participation in the study. 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: Contraindication to general anaesthesia Diabetic neuropathy affecting lower limbs Peripheral neuropathy affecting lower limbs of any aetiology Revision surgery Lack of capacity to consent

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ankle + Sham metatarsal<br>Ankle block + sham metatarsal block | Procedure: Ankle block<br>* Ultrasound guided ankle block of the tibial, superficial peroneal and deep peroneal nerves will be performed using a standardised technique<br>Procedure: Sham metatarsal block<br>* 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.<br>|
| Active Comparator: Ankle + Metatarsal<br>Ankle block + metatarsal block | Procedure: Ankle block<br>* Ultrasound guided ankle block of the tibial, superficial peroneal and deep peroneal nerves will be performed using a standardised technique<br>Procedure: Metatarsal block<br>* A metatarsal block will be performed using a standardised technique<br>|
| Active Comparator: Metatarsal + sham ankle<br>Metatarsal block + sham ankle block | Procedure: Sham ankle block<br>* 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.<br>Procedure: Metatarsal block<br>* A metatarsal block will be performed using a standardised technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Static pain score | Visual Analogue scores | 6 hours post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic pain scores | Visual Analogue scores | 6 hours post-operatively | 
| Dynamic pain scores | Visual Analogue scores | Day 1 post-operatively | 
| Dynamic pain scores | Visual Analogue scores | Day 7 post-operatively | 
| Assessment of functional recovery | Using Functional Recovery Index | 6 hours post-operatively | 
| Assessment of functional recovery | Using Functional Recovery Index | Day 1 post-operatively | 
| Assessment of functional recovery | Using Functional Recovery Index | Day 7 post-operatively | 
| Static pain score | Visual Analogue scores | Day 1 post-operatively | 
| Static pain score | Visual Analogue scores | Day 7 post-operatively |