Ultrasound Guided Ankle Block Versus Medial Forefoot Block for Forefoot Surgery (USGAB)
This study has been completed.
Sponsor:
Hull and East Yorkshire Hospitals NHS Trust
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: April 15, 2015
Last verified: April 2015
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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:
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.
| 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| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01386320
Please refer to this study by its ClinicalTrials.gov identifier: 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:
| 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: | April 15, 2015 |
| 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 September 30, 2016