Ultrasound Guided Ankle Block Versus Medial Forefoot Block for Forefoot Surgery (USGAB)
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|ClinicalTrials.gov Identifier: NCT01386320|
Recruitment Status : Completed
First Posted : July 1, 2011
Last Update Posted : July 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pain Relief After Forefoot Surgery||Procedure: Ultrasound guided ankle block Procedure: Medial forefoot block||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Randomised, Blinded Comparison of an Ultrasound Guided Ankle Block Compared to a Nerve Stimulator Guided Ankle Block for Pain Relief After Forefoot Surgery.|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
Active Comparator: Ultrasound guided ankle block
Subjects in this arm will be given an ultrasound guided ankle block prior to foot surgery.
Procedure: 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.
Active Comparator: Medial forefoot block
Subjects in this arm will be given a nerve-stimulator guided forefoot block prior to anaesthesia and forefoot surgery
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.
- Time taken to carry out each local anaesthetic block [ Time Frame: Over forty five minutes from the start of the study. ]Time taken between opening sterile packs and completion of local anaesthetic block is measured by a blind observer.
- Onset of local anaesthesia [ Time Frame: Over thirty minutes from completion of the local anaesthetic block. ]Following administration of the local block, development of anaesthesia will be measured looking at cold and pin-prick sensation by a blind observer.
- Duration of pain relief following local anaesthetic block. [ Time Frame: Over 24 hours following surgery. ]Pain relief will be assessed over 24 hours following surgery, to assess its duration and quality, by a blind observer.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01386320
|Castle Hill Hospital, Castle Road, Cottingham|
|Hull, East Yorkshire, United Kingdom, HU16 5JQ|
|Principal Investigator:||Andrew J Coe, FRCA||Hull University Teaching Hospitals NHS Trust|