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Ultrasound Guided Ankle Block Versus Medial Forefoot Block for Forefoot Surgery (USGAB)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01386320
First Posted: July 1, 2011
Last Update Posted: April 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Andrew J Coe, Hull and East Yorkshire Hospitals NHS Trust
  Purpose
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.

Condition Intervention
Pain Relief After Forefoot Surgery Procedure: Ultrasound guided ankle block Procedure: Medial forefoot block

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia Ultrasound
U.S. FDA Resources

Further study details as provided by Dr. Andrew J Coe, Hull and East Yorkshire Hospitals NHS Trust:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.
Enrollment: 60
Study Start Date: February 2011
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fit adult patients requiring forefoot surgery with bone cutting.

Exclusion Criteria:

  • Morbid obesity (BMI >40), known contraindications to regional anaesthesia
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United Kingdom
Castle Hill Hospital, Castle Road, Cottingham
Hull, East Yorkshire, United Kingdom, HU16 5JQ
Sponsors and Collaborators
Hull and East Yorkshire Hospitals NHS Trust
Investigators
Principal Investigator: Andrew J Coe, FRCA Hull and East Yorkshire Hospitals NHS Trust
  More Information

Publications:
Chin KJ, Chan V. Ultrasound-guided peripheral nerve blockade. Curr Opin Anaesthesiol. 2008 Oct;21(5):624-31. doi: 10.1097/ACO.0b013e32830815d1. Review.

Responsible Party: Dr. Andrew J Coe, Dr, Hull and East Yorkshire Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01386320     History of Changes
Other Study ID Numbers: R0929 10/1304/1
First Submitted: June 29, 2011
First Posted: July 1, 2011
Last Update Posted: April 16, 2015
Last Verified: April 2015

Keywords provided by Dr. Andrew J Coe, Hull and East Yorkshire Hospitals NHS Trust:
anaesthetic techniques, regional; surgery orthopaedic


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