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

This study is currently recruiting participants.

Verified September 2011 by Hull and East Yorkshire Hospitals NHS Trust

Sponsor:

Information provided by (Responsible Party):

Dr. Andrew J Coe, Hull and East Yorkshire Hospitals NHS Trust

ClinicalTrials.gov Identifier:

NCT01386320

First received: June 29, 2011

Last updated: September 30, 2011

Last verified: September 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

June 29, 2011

Last Updated Date

September 30, 2011

Start Date ^ICMJE

February 2011

Estimated Primary Completion Date

October 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Time taken to carry out each local anaesthetic block [ Time Frame: Over forty five minutes from the start of the study. ] [ Designated as safety issue: No ]

Time taken between opening sterile packs and completion of local anaesthetic block is measured by a blind observer.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01386320 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Onset of local anaesthesia [ Time Frame: Over thirty minutes from completion of the local anaesthetic block. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
Pain relief will be assessed over 24 hours following surgery, to assess its duration and quality, by a blind observer.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Ultrasound Guided Ankle Block Versus Medial Forefoot Block for Forefoot Surgery

Official Title ^ICMJE

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

Brief Summary

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Pain Relief After Forefoot Surgery

Intervention ^ICMJE

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.
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.

Study Arm (s)

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

Intervention: Procedure: Ultrasound guided ankle block
Active Comparator: Medial forefoot block
Subjects in this arm will be given a nerve-stimulator guided forefoot block prior to anaesthesia and forefoot surgery

Intervention: Procedure: Medial forefoot block

Publications *

Chin KJ, Chan V. Ultrasound-guided peripheral nerve blockade. Curr Opin Anaesthesiol. 2008 Oct;21(5):624-31. Review.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2014

Estimated Primary Completion Date

October 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Fit adult patients requiring forefoot surgery with bone cutting.

Exclusion Criteria:

Morbid obesity (BMI >40), known contraindications to regional anaesthesia

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01386320

Other Study ID Numbers ^ICMJE

R0929 10/1304/1

Has Data Monitoring Committee

Responsible Party

Dr. Andrew J Coe, Hull and East Yorkshire Hospitals NHS Trust

Study Sponsor ^ICMJE

Hull and East Yorkshire Hospitals NHS Trust

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Andrew J Coe, FRCA

Hull and East Yorkshire Hospitals NHS Trust

Information Provided By

Hull and East Yorkshire Hospitals NHS Trust

Verification Date

September 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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