Hallux Valgus Ambulatory SurgeryObservationnalNCT03815422
Plantar Compartment Block in Hallux Valgus Ambulatory Surgery
An observational study of Hallux Valgus Ambulatory Surgery, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Hallux valgus surgery is known as a painful surgery. Qualitative pain management is the key to successful early recovery and rehabilitation. Popliteal sciatic nerve block is widely used despite the risk of falling due to prolonged motor blockade. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Valgus Ambulatory Surgery
- What is being tested?
- Regional anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2017to 31 Dec 2019
- Phase
- Observational
- 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
Study population: Patients with Plantar compartment block in Hallux Valgus ambulatory surgery
Who may be able to join
- Age between 18 and 75 years old
- patient covered by social health insurance
- have signed written informed consent
- scheduled for hallux valgus ambulatory surgery
Who cannot join
- protected patients or patients incapable of giving written informed consent
- pregnant or breastfeeding woman
- vulnerable adult
- inability to participate in pain scoring scales
- severe coagulopathy
- allergy or contraindications to study drugs
Show all 12Show fewer
- preopérative gait disorders
- chronic kidney disease with glomerular filtration rate (GFR) ≤ 50 ml/min (estimated by the Cockroft and Gault formula)
- severe chronic liver disease
- chronic pain (treated by non steroidal anti inflammatory drugs, opioids, neuroleptic drugs, antidepressant or anticonvulsants)
- peripheral neuropathy
- intervention under general anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesia Quality and Quality of Deambulation of the Plantar Compartment Block After Hallux Valgus Ambulatory Surgery.
Hallux valgus surgery is known as a painful surgery. Qualitative pain management is the key to successful early recovery and rehabilitation.
Popliteal sciatic nerve block is widely used despite the risk of falling due to prolonged motor blockade.
Plantar block combined with distal peroneal block may be a better analgesic option in order to provide fast track rehabilitation.
The purpose of this study is to describe the analgesic effect of the plantar compartment block following hallux valgus surgery.
- Conditions
- Hallux Valgus Ambulatory Surgery
- Being tested
- Regional anesthesia
- Keywords
- Early ambulation, Plantar block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional anesthesiaProcedure or surgery
Short lasting sciatic nerve block and long lasting plantar block with distal deep peroneal block
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesia quality of the plantar compartment block
after Hallux Valgus ambulatory surgery
Measured: 48 hours
Secondary outcomes (2)
Quality of deambulation
48 hours
Measured: Quality of deambulation during the first 2 postoperative days.
postoperative analgesic
48 hours
Measured: postoperative analgesic requirement, during the first 2 postoperative days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start1 Dec 2017
- Primary completion1 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hallux Valgus Ambulatory SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabien SWISSER, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815422
- Sponsor's protocol ID
- RECHMPL18_0143
- Acronym
- Observationnal
- Status last verified
- Mar 2020
- First submitted
- 21 Jan 2019
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
Herteleer M, Choquet O, Swisser F, Bernard N, Gasc A, Canovas F, Dagneaux L, Bringuier S, Capdevila X. Plantar compartment block for hallux valgus surgery: a proof-of-concept anatomic and clinical study. Reg Anesth Pain Med. 2024 Feb 19:rapm-2023-105246. doi: 10.1136/rapm-2023-105246. Online ahead of print.
PubMed 38373818
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesia Quality and Quality of Deambulation of the Plantar Compartment Block After Hallux Valgus Ambulatory Surgery.
- ClinicalTrials.gov ID
- NCT03815422
- Acronym / sponsor ID
- Observationnal / RECHMPL18_0143
- Conditions
- Hallux Valgus Ambulatory Surgery
- Keywords
- Early ambulation, Plantar block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 24 Jan 2019 (actual)
- 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.
Hallux valgus surgery is known as a painful surgery. Qualitative pain management is the key to successful early recovery and rehabilitation.
Popliteal sciatic nerve block is widely used despite the risk of falling due to prolonged motor blockade.
Plantar block combined with distal peroneal block may be a better analgesic option in order to provide fast track rehabilitation.
The purpose of this study is to describe the analgesic effect of the plantar compartment block following hallux valgus surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Plantar compartment block in Hallux Valgus ambulatory surgery
Key inclusion criteria (4 listed)
- Age between 18 and 75 years old
- patient covered by social health insurance
- have signed written informed consent
- scheduled for hallux valgus ambulatory surgery
Key exclusion criteria (12 listed)
- protected patients or patients incapable of giving written informed consent
- pregnant or breastfeeding woman
- vulnerable adult
- inability to participate in pain scoring scales
- severe coagulopathy
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 |
|---|---|---|
| Regional anesthesiaShort lasting sciatic nerve block and long lasting plantar block with distal deep peroneal block | Procedure or surgery | – |
Primary outcome
Analgesia quality of the plantar compartment block
Time frame: 48 hours
after Hallux Valgus ambulatory surgery
2 secondary outcomes
Quality of deambulation
Time frame: Quality of deambulation during the first 2 postoperative days.
postoperative analgesic
Time frame: postoperative analgesic requirement, during the first 2 postoperative days.
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 10 Mar 2020.
- Derived from this study: PubMed 38373818Herteleer M, Choquet O, Swisser F, Bernard N, Gasc A, Canovas F, Dagneaux L, Bringuier S, Capdevila X. Plantar compartment block for hallux valgus surgery: a proof-of-concept anatomic and clinical study. Reg Anesth Pain Med. 2024 Feb 19:rapm-2023-105246. doi: 10.1136/rapm-2023-105246. Online ahead of print.
- Individual participant dataSharing planned: Undecided. NC
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.
Fabien SWISSER, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hallux Valgus Ambulatory Surgery, run by University Hospital, Montpellier at 1 site in France.
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 12 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 10 Mar 2020. 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 France. 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?
Analgesia quality of the plantar compartment block (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03815422, which also lists 1 linked publication.
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 10 Mar 2020; AzTrials last refreshed its copy on 7 Nov 2026.