Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Hull and East Yorkshire Hospitals NHS Trust.
Recruitment status was  Recruiting
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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by 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. ] [ Designated as safety issue: No ]
    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. ] [ 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.
Estimated Enrollment: 60
Study Start Date: February 2011
Estimated Study Completion Date: October 2014
Estimated 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
Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01386320

Locations
United Kingdom
Castle Hill Hospital, Castle Road, Cottingham Recruiting
Hull, East Yorkshire, United Kingdom, HU16 5JQ
Contact: Andrew J Coe, FRCA    01482 875875 ext 4542    andrew.coe@hey.nhs.uk   
Contact: Ram Sundaram, FRCA    01482 875875 ext 4542    sundaram.ram@hey.nhs.uk   
Principal Investigator: Andrew J Coe, FRCA         
Sub-Investigator: Sundaram Ram, FRCA         
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:

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
Study First Received: June 29, 2011
Last Updated: September 30, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Hull and East Yorkshire Hospitals NHS Trust:
anaesthetic techniques, regional; surgery orthopaedic

ClinicalTrials.gov processed this record on February 27, 2015