Ultrasound Guided Ankle Block Versus Medial Forefoot Block for Forefoot Surgery

NCT ID: NCT01386320

Last Updated: 2019-07-15

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-10-31

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.

Detailed Description

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Conditions

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Pain Relief After Forefoot Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Ultrasound guided ankle block

Subjects in this arm will be given an ultrasound guided ankle block prior to foot surgery.

Group Type ACTIVE_COMPARATOR

Ultrasound guided ankle block

Intervention Type PROCEDURE

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.

Medial forefoot block

Subjects in this arm will be given a nerve-stimulator guided forefoot block prior to anaesthesia and forefoot surgery

Group Type ACTIVE_COMPARATOR

Medial forefoot block

Intervention Type PROCEDURE

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.

Interventions

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Ultrasound guided ankle block

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.

Intervention Type PROCEDURE

Medial forefoot block

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.

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hull University Teaching Hospitals NHS Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew J Coe, FRCA

Role: PRINCIPAL_INVESTIGATOR

Hull University Teaching Hospitals NHS Trust

Locations

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Castle Hill Hospital, Castle Road, Cottingham

Hull, East Yorkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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R0929 10/1304/1

Identifier Type: -

Identifier Source: org_study_id

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