Hallux ValgusNCT01445249
Medial Forefoot Block for Analgesia After Foot Surgery
A study testing Landmark guided ankle block. and PNS guided block. in people with Hallux Valgus, 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 are used to provide pain relief after this work. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- Landmark guided ankle block. and PNS guided block.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2007to Mar 2009
- 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 adults 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 a Nerve Stimulator Guided Ankle Block Compared to a Landmark 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 are used to provide pain relief after this work. The purpose of this study is to compare two techniques: one using anatomical landmarks alone to guide local anaesthetic infiltration, the other using peripheral nerve stimulation to guide local anaesthetic infiltration (termed medial forefoot block). The two techniques will be compared for reliability of postoperative analgesia.
Read the detailed description
More extensive description not desired.
- Conditions
- Hallux Valgus
- Being tested
- Landmark guided ankle block., PNS guided block.
- Keywords
- regional anaesthetic techniques, surgery orthopaedic
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Landmark guided ankle block.Procedure or surgery
Also called Other names not required
25-30mls 0.5% levobupivacaine will be infiltrated to provide a landmark guided ankle block.
PNS guided block.Procedure or surgery
Also called Other names not required
This group will have 25-30mls of 0.5% levobupivacaine infiltrated as directed by peripheral nerve stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Landmark guided ankle block | Active comparator | This group will receive a landmark guided ankle block. Receives: Procedure: Landmark guided ankle block. |
| This group will be given a PNS guided ankle block | Active comparator | Peripheral nerve stimulation will be used in this group to guide local anaesthetic infiltration. The technique is termed medial forefoot block. Receives: Procedure: PNS guided block. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of local anaesthetic block.
The number of patients in each study arm with altered sensation to cold and pin prick, together with no requirement for opiate analgesia, following surgery was recorded.
Measured: Over ninety minutes from the start of the study.
Secondary outcomes (1)
Intravenous opiate usage following surgery
The usage of intravenous morphine, delivered by a ptient controlled analgesia system, in each group was recorded.
Measured: 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 posted3 Oct 2011 (estimated)
- Study startMar 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Andrew J Coe, MbChB FRCA, Principal investigator, Hull and East Yorks NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01445249
- Sponsor's protocol ID
- 07/H1304/118
- Status last verified
- Jul 2019
- First submitted
- 17 Aug 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 a Nerve Stimulator Guided Ankle Block Compared to a Landmark Guided Ankle Block for Pain Relief After Forefoot Surgery.
- ClinicalTrials.gov ID
- NCT01445249
- Acronym / sponsor ID
- 07/H1304/118
- Conditions
- Hallux Valgus
- Keywords
- regional anaesthetic techniques, surgery orthopaedic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Study start
- Mar 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 3 Oct 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 are used to provide pain relief after this work. The purpose of this study is to compare two techniques: one using anatomical landmarks alone to guide local anaesthetic infiltration, the other using peripheral nerve stimulation to guide local anaesthetic infiltration (termed medial forefoot block). The two techniques will be compared for reliability of postoperative analgesia.
Detailed description
More extensive description not desired.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Landmark guided ankle block | Active comparator | Procedure: Landmark guided ankle block.This group will receive a landmark guided ankle block. |
| This group will be given a PNS guided ankle block | Active comparator | Procedure: PNS guided block.Peripheral nerve stimulation will be used in this group to guide local anaesthetic infiltration. The technique is termed medial forefoot block. |
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 adults requiring forefoot surgery with bone cutting
Key exclusion criteria (2 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 |
|---|---|---|
| Landmark guided ankle block.Also: Other names not required25-30mls 0.5% levobupivacaine will be infiltrated to provide a landmark guided ankle block. | Procedure or surgery | Landmark guided ankle block |
| PNS guided block.Also: Other names not requiredThis group will have 25-30mls of 0.5% levobupivacaine infiltrated as directed by peripheral nerve stimulation. | Procedure or surgery | This group will be given a PNS guided ankle block |
Primary outcome
Efficacy of local anaesthetic block.
Time frame: Over ninety minutes from the start of the study.
The number of patients in each study arm with altered sensation to cold and pin prick, together with no requirement for opiate analgesia, following surgery was recorded.
1 secondary outcome
Intravenous opiate usage following surgery
Time frame: 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.
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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, MbChB FRCA principal investigator
Hull and East Yorks 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 Landmark guided ankle block. and PNS guided block. in people with Hallux Valgus, 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 2 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?
Efficacy of local anaesthetic block. (time frame: Over ninety 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.