Hallux ValgusNCT02637362
Optimal Analgesia for Forefoot Surgery
A study testing Ankle block and Metatarsal block in people with Hallux Valgus and Conduction Block, run by Queen Elizabeth Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
A randomised trial comparing three analgesic strategies for patients undergoing forefoot surgery in a day-surgery setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Valgus, Conduction Block
- What is being tested?
- Ankle block and Metatarsal block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Feb 2018to Jun 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or female, aged 18 years or above.
- Diagnosed with 1st metatarsal pathology requiring surgical correction
- Participant meets the criteria for operative management in our day-surgery unit
Who cannot join
- Contraindication to general anaesthesia
- Diabetic neuropathy affecting lower limbs
- Peripheral neuropathy affecting lower limbs of any aetiology
- Revision surgery
- Lack of capacity to consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Queen Elizabeth Hospital NHS Trust
Kings Lynn, Norfolk, PE304ET
James A Stimpson, MBChB, 01553613613 ext. 3583, jamesstimpson@btinternet.com
About this study
Official title: Optimal Analgesia Following Metatarsal Surgery: A Prospective Randomised, Single-Blind Sham-Controlled Trial of Three Strategies
A randomised trial comparing three analgesic strategies for patients undergoing forefoot surgery in a day-surgery setting.
Read the detailed description
Forefoot surgery, including Scarf-Akin osteotomy surgery for bunion correction, is moderately painful orthopaedic surgery, commonly performed as a day-case procedure. Admission for opiate analgesia constitutes a failure of management and financial disadvantage to the healthcare organisation. The investigators seek to establish which technique will result in the best analgesia out of ankle block, metatarsal block, or a combination of the two. As analgesia constitutes part of a return to function, an additional aim is to determine whether either of these approaches will result in an objective functional benefit to the participants.
The trial seeks to recruit 23 patients into either of 3 groups: Ankle + sham metatarsal; sham Ankle + metatarsal; Ankle + Metatarsal.
- Conditions
- Hallux Valgus, Conduction Block
- Being tested
- Ankle block, Sham ankle block, Metatarsal block, Sham metatarsal block
- Medical subject headings
- Hallux Valgus, Heart Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle blockProcedure or surgery
Ultrasound guided ankle block of the tibial, superficial peroneal and deep peroneal nerves will be performed using a standardised technique
Sham ankle blockProcedure or surgery
In the supine position with the hip and knee flexed, and the hip externally rotated, the skin from medial malleolus to Achilles tendon will be prepared with chlorhexidine 0.5% solution and allowed to dry. An ultrasound probe (linear array HFL25, Sonosite, Hitchin, UK) will be placed on a line from medial malleolus to achilles tendon to identify the posterior tibial artery and tibial nerve. A Stimuplex A50 needle (B-Braun) will be placed against the skin at the point at which the practitioner would normally have performed insertion of the needle. It will remain there for a total of 30 seconds and then will be removed.
Metatarsal blockProcedure or surgery
A metatarsal block will be performed using a standardised technique
Sham metatarsal blockProcedure or surgery
In the supine position, after the surgical incision has been sutured, a 25G standard bevel needle will be placed against the skin at the points at which the practitioner would normally have performed insertions of the needle. It will remain there for a total of 30 seconds and then be removed.
| Study group | Role | What they receive |
|---|---|---|
| Ankle + Sham metatarsal | Active comparator | Ankle block + sham metatarsal block Receives: Procedure: Ankle block; Procedure: Sham metatarsal block |
| Ankle + Metatarsal | Active comparator | Ankle block + metatarsal block Receives: Procedure: Ankle block; Procedure: Metatarsal block |
| Metatarsal + sham ankle | Active comparator | Metatarsal block + sham ankle block Receives: Procedure: Sham ankle block; Procedure: Metatarsal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static pain score
Visual Analogue scores
Measured: 6 hours post-operatively
Secondary outcomes (8)
Dynamic pain scores
Visual Analogue scores
Measured: 6 hours post-operatively
Dynamic pain scores
Visual Analogue scores
Measured: Day 1 post-operatively
Dynamic pain scores
Visual Analogue scores
Measured: Day 7 post-operatively
Assessment of functional recovery
Using Functional Recovery Index
Measured: 6 hours post-operatively
Assessment of functional recovery
Using Functional Recovery Index
Measured: Day 1 post-operatively
Assessment of functional recovery
Using Functional Recovery Index
Measured: Day 7 post-operatively
Static pain score
Visual Analogue scores
Measured: Day 1 post-operatively
Static pain score
Visual Analogue scores
Measured: Day 7 post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study start2 Feb 2018
- Primary completionDec 2018 (estimated)
- Study completionJun 2019 (estimated)
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Elizabeth Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr James Stimpson, Queen Elizabeth Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637362
- Sponsor's protocol ID
- JSCP1
- Status last verified
- Apr 2018
- First submitted
- 16 Dec 2015
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Analgesia Following Metatarsal Surgery: A Prospective Randomised, Single-Blind Sham-Controlled Trial of Three Strategies
- ClinicalTrials.gov ID
- NCT02637362
- Acronym / sponsor ID
- JSCP1
- Conditions
- Hallux Valgus, Conduction Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Queen Elizabeth Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 22 Dec 2015 (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.
A randomised trial comparing three analgesic strategies for patients undergoing forefoot surgery in a day-surgery setting.
Detailed description
Forefoot surgery, including Scarf-Akin osteotomy surgery for bunion correction, is moderately painful orthopaedic surgery, commonly performed as a day-case procedure. Admission for opiate analgesia constitutes a failure of management and financial disadvantage to the healthcare organisation. The investigators seek to establish which technique will result in the best analgesia out of ankle block, metatarsal block, or a combination of the two. As analgesia constitutes part of a return to function, an additional aim is to determine whether either of these approaches will result in an objective functional benefit to the participants.
The trial seeks to recruit 23 patients into either of 3 groups: Ankle + sham metatarsal; sham Ankle + metatarsal; Ankle + Metatarsal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ankle + Sham metatarsal | Active comparator | Procedure: Ankle block, Procedure: Sham metatarsal blockAnkle block + sham metatarsal block |
| Ankle + Metatarsal | Active comparator | Procedure: Ankle block, Procedure: Metatarsal blockAnkle block + metatarsal block |
| Metatarsal + sham ankle | Active comparator | Procedure: Sham ankle block, Procedure: Metatarsal blockMetatarsal block + sham ankle block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or female, aged 18 years or above.
- Diagnosed with 1st metatarsal pathology requiring surgical correction
- Participant meets the criteria for operative management in our day-surgery unit
Key exclusion criteria (5 listed)
- Contraindication to general anaesthesia
- Diabetic neuropathy affecting lower limbs
- Peripheral neuropathy affecting lower limbs of any aetiology
- Revision surgery
- Lack of capacity to consent
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 |
|---|---|---|
| Ankle blockUltrasound guided ankle block of the tibial, superficial peroneal and deep peroneal nerves will be performed using a standardised technique | Procedure or surgery | Ankle + Metatarsal, Ankle + Sham metatarsal |
| Sham ankle blockIn the supine position with the hip and knee flexed, and the hip externally rotated, the skin from medial malleolus to Achilles tendon will be prepared with chlorhexidine 0.5% solution and allowed to dry. An ultrasound probe (linear array HFL25, Sonosite, Hitchin, UK) will be placed on a line from medial malleolus to achilles tendon to identify the posterior tibial artery and tibial nerve. A Stimuplex A50 needle (B-Braun) will be placed against the skin at the point at which the practitioner would normally have performed insertion of the needle. It will remain there for a total of 30 seconds and then will be removed. | Procedure or surgery | Metatarsal + sham ankle |
| Metatarsal blockA metatarsal block will be performed using a standardised technique | Procedure or surgery | Ankle + Metatarsal, Metatarsal + sham ankle |
| Sham metatarsal blockIn the supine position, after the surgical incision has been sutured, a 25G standard bevel needle will be placed against the skin at the points at which the practitioner would normally have performed insertions of the needle. It will remain there for a total of 30 seconds and then be removed. | Procedure or surgery | Ankle + Sham metatarsal |
Primary outcome
Static pain score
Time frame: 6 hours post-operatively
Visual Analogue scores
8 secondary outcomes
Dynamic pain scores
Time frame: 6 hours post-operatively
Dynamic pain scores
Time frame: Day 1 post-operatively
Dynamic pain scores
Time frame: Day 7 post-operatively
Assessment of functional recovery
Time frame: 6 hours post-operatively
Assessment of functional recovery
Time frame: Day 1 post-operatively
Assessment of functional recovery
Time frame: Day 7 post-operatively
Static pain score
Time frame: Day 1 post-operatively
Static pain score
Time frame: Day 7 post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle block and Metatarsal block in people with Hallux Valgus and Conduction Block, run by Queen Elizabeth Hospital NHS Foundation 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 May 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James A Stimpson, MBChB (+44 (01553) 613613 ext. 3583, james.stimpson@qehkl.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static pain score (time frame: 6 hours post-operatively). 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 1 May 2018; AzTrials last refreshed its copy on 29 Oct 2026.