Pain Relief After Forefoot SurgeryUSGABNCT01386320
Ultrasound Guided Ankle Block Versus Medial Forefoot Block for Forefoot Surgery
A study testing Ultrasound guided ankle block and Medial forefoot block in people with Pain Relief After Forefoot Surgery, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pain Relief After Forefoot Surgery
- What is being tested?
- Ultrasound guided ankle block and Medial forefoot block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2011to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fit adult patients requiring forefoot surgery with bone cutting.
Who cannot join
- Morbid obesity (BMI >40), known contraindications to regional anaesthesia
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Castle Hill Hospital, Castle Road, Cottingham
Hull, East Yorkshire, HU16 5JQ
About this study
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.
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.
- Conditions
- Pain Relief After Forefoot Surgery
- Being tested
- Ultrasound guided ankle block, Medial forefoot block
- Keywords
- anaesthetic techniques, regional; surgery orthopaedic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided ankle blockProcedure or surgery
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.
Medial forefoot blockProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Ultrasound guided ankle block | Active comparator | Subjects in this arm will be given an ultrasound guided ankle block prior to foot surgery. Receives: Procedure: Ultrasound guided ankle block |
| Medial forefoot block | Active comparator | Subjects in this arm will be given a nerve-stimulator guided forefoot block prior to anaesthesia and forefoot surgery Receives: Procedure: Medial forefoot block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time taken to carry out each local anaesthetic block
Time taken between opening sterile packs and completion of local anaesthetic block is measured by a blind observer.
Measured: Over forty five minutes from the start of the study.
Secondary outcomes (2)
Onset of local anaesthesia
Following administration of the local block, development of anaesthesia will be measured looking at cold and pin-prick sensation by a blind observer.
Measured: Over thirty minutes from completion of the local anaesthetic block.
Duration of pain relief following local anaesthetic block.
Pain relief will be assessed over 24 hours following surgery, to assess its duration and quality, by a blind observer.
Measured: Over 24 hours following surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2011 (estimated)
- Study startFeb 2011
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Relief After Forefoot SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Andrew J Coe, FRCA, Principal investigator, Hull University Teaching Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386320
- Sponsor's protocol ID
- R0929 10/1304/1
- Acronym
- USGAB
- Status last verified
- Jul 2019
- First submitted
- 29 Jun 2011
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01386320
- Acronym / sponsor ID
- USGAB / R0929 10/1304/1
- Conditions
- Pain Relief After Forefoot Surgery
- Keywords
- anaesthetic techniques, regional; surgery orthopaedic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Study start
- Feb 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 1 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided ankle block | Active comparator | Procedure: Ultrasound guided ankle blockSubjects in this arm will be given an ultrasound guided ankle block prior to foot surgery. |
| Medial forefoot block | Active comparator | Procedure: Medial forefoot blockSubjects in this arm will be given a nerve-stimulator guided forefoot block prior to anaesthesia and forefoot surgery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fit adult patients requiring forefoot surgery with bone cutting.
Key exclusion criteria (1 listed)
- Morbid obesity (BMI >40), known contraindications to regional anaesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound guided ankle blockUnder 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 or surgery | Ultrasound guided ankle block |
| Medial forefoot blockUsing 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. | Procedure or surgery | Medial forefoot block |
Primary outcome
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.
2 secondary outcomes
Onset of local anaesthesia
Time frame: Over thirty minutes from completion of the local anaesthetic block.
Duration of pain relief following local anaesthetic block.
Time frame: Over 24 hours following surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew J Coe, FRCA principal investigator
Hull University Teaching Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided ankle block and Medial forefoot block in people with Pain Relief After Forefoot Surgery, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time taken to carry out each local anaesthetic block (time frame: Over forty five minutes from the start of the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.