AnesthesiaPlantar-blockNCT03922412
Plantar Compartment Block Versus Sciatic Block in Hallux Valgus Ambulatory Surgery
A study testing PLANTAR BLOCK and Sciatic popliteal block in people with Anesthesia, 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. Sciatic popliteal 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 to 75 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- PLANTAR BLOCK and Sciatic popliteal block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jun 2019to 26 Nov 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
- preoperative gait disorders
- chronic kidney disease with glomerular filtration rate (GFR) ≤ 50 ml/min (estimated by the Cockcroft 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: Plantar Compartment Block Versus Sciatic Block in Hallux Valgus Ambulatory Surgery : a Prospective, Randomised, Double Blind Study
Hallux valgus surgery is known as a painful surgery. Qualitative pain management is the key to successful early recovery and rehabilitation.
Sciatic popliteal nerve block is widely used despite the risk of falling due to prolonged motor blockade.
Read more
Plantar block combined with distal peroneal block may be a better analgesic option in order to provide fast track rehabilitation.
This study aims to determine the quality of deambulation following hallux valgus surgery.
Block quality, post operative pain, patient satisfaction and length of hospital stay will be compared in this study.
Patients scheduled for ambulatory (hallux valgus) surgery under regional anaesthesia alone (without general anesthesia) will be recruited.
Consenting patients will be randomized the day of surgery to one of those two groups :
- Short lasting sciatic nerve block (mepivacaine 1% 200mg) and long lasting plantar block (ropivacaine 0,5% 25mg + 2mg dexamethasone) with distal deep peroneal block (ropivacaine 0,5% 2ml).
- Long lasting sciatic nerve block (ropivacaine 0,5% 100mg + 2mg dexamethasone)
All patients will benefit from post operative analgesia including paracetamol, nonsteroidal antiinflammatory drugs intravenously.
During PACU stay, pain will be assessed using the VAS (visual analogue scale) score, and analgesic IV consumption.
Temporospatial gait analysis will be assessed with a GAITRITE system before the patient leave the hospital.
Deambulation and walking ability will be evaluated at home postoperatively to day 3 using an acetimetry bracelet.
Pain, postoperative analgesic requirement, sleep quality and overall patient satisfaction (EVAN-LR) will also be assessed during the first 3 postoperative days.
Read the detailed description
Hallux valgus surgery is known as a painful surgery. Qualitative pain management is the key to successful early recovery and rehabilitation.
Sciatic popliteal 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.
This study aims to determine the quality of deambulation following hallux valgus surgery.
Block quality, post operative pain, patient satisfaction and length of hospital stay will be compared in this study.
Patients scheduled for ambulatory (hallux valgus) surgery under regional anaesthesia alone (without general anesthesia) will be recruited.
Consenting patients will be randomized the day of surgery to one of those two groups :
- Short lasting sciatic nerve block (mepivacaine 1% 200mg) and long lasting plantar block (ropivacaine 0,5% 25mg + 2mg dexamethasone) with distal deep peroneal block (ropivacaine 0,5% 2ml).
- Long lasting sciatic nerve block (ropivacaine 0,5% 100mg + 2mg dexamethasone)
All patients will benefit from post operative analgesia including paracetamol, nonsteroidal antiinflammatory drugs intravenously.
During PACU stay, pain will be assessed using the VAS (visual analogue scale) score, and analgesic IV consumption.
Temporospatial gait analysis will be assessed with a GAITRITE system before the patient leave the hospital (6 hours after ALR).
Deambulation and walking ability will be evaluated at home postoperatively to day 3 using an acetimetry bracelet.
Pain, postoperative analgesic requirement, sleep quality and overall patient satisfaction (EVAN-LR) will also be assessed during the first 3 postoperative days.
- Conditions
- Anesthesia
- Being tested
- PLANTAR BLOCK, Sciatic popliteal block
- Keywords
- Anesthesia, plantar Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLANTAR BLOCKProcedure or surgery
- Sciatic popliteal block : patient in lateral position, injection of 20 ml of the mixture labelled " BLOC POPLITE " containing 20 ml of mepivacain 1% (200mg)
- Plantar block 10 minutes later : patient in supine position. Medial midfoot injection of 5 ml of the mixture labelled " BLOC PLANTAIRE " containing 5 ml of Ropivacaine 0,5% (25mg) with 0,5 ml dexaméthasone (2mg)
- Distal deep fibular block : patient in supine position, injection around the dorsal foot artery of 2 ml of the mixture labelled " BLOC FIBULAIRE " containing 2 ml of Ropivacaine 0,5% (10mg).
Sciatic popliteal blockProcedure or surgery
1-Sciatic popliteal block : patient in lateral position, injection of 20 ml of the mixture labelled " BLOC POPLITE " containing 20 ml of ropivacaine 0,5% (100mg) with 2mg (0,5 ml) of dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| plantar block | Active comparator | Short lasting sciatic nerve block (mepivacaine 1% 200mg) and long lasting plantar block (ropivacaine 0,5% 25mg + 2mg dexamethasone) with distal deep peroneal block (ropivacaine 0,5% 2ml). Receives: Procedure: PLANTAR BLOCK |
| Sciatic popliteal block | Active comparator | Long lasting sciatic nerve block (ropivacaine 0,5% 100mg + 2mg dexamethasone) Receives: Procedure: Sciatic popliteal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of steps walking ability assessed by GAITRITE Test
Comparison of the deambulation assessed by GAITRITE test (walking test) between patient who received plantar block and patient who received sciatic popliteal block
Measured: 6 hours after ALR
Secondary outcomes (6)
Quantity of postoperative rescue analgesics taken
Comparison of the postoperative pain assessed by the Quantity of post-operative rescue analgesics between each group of patients
Measured: up to 3 days after surgery
Assessment of the quality of the sensory blocks
Comparison of the sensory territories of anesthesia using cold between each group
Measured: during the surgery
Assessment of the patient hospitalisation duration
Comparison of the duration of hospitalization between each group
Measured: up to 3 days after surgery
Assessment of overall patient satisfaction assessed by the scale EVAN Loco regional
Comparison of overall patient satisfaction between each group
Measured: up to 3 days after surgery
Assessment of sleep quality Assessment of patient sleep quality
Comparison of patient sleep quality assessed by the somnifer consumption during the postoperative hospitalization between each group
Measured: up to 3 days after surgery
Efficacity of patient walking ability
Comparison of the deambulation assessed by acetemeter between patient who received plantar block and patient who received sciatic popliteal block
Measured: up to 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start24 Jun 2019
- Primary completion23 Nov 2022
- Study completion26 Nov 2022
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 AnesthesiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922412
- Sponsor's protocol ID
- RECHMPL18_0489
- Acronym
- Plantar-block
- Status last verified
- May 2026
- First submitted
- 11 Apr 2019
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Swisser F, Brethe Y, Choquet O, Herteleer M, Bernard N, Laffont I, Bringuier S, Capdevila X. Plantar Compartment Block Improves Enhanced Recovery after Hallux Valgus Surgery: A Randomized, Comparative, Double-blind Study. Anesthesiology. 2024 Nov 1;141(5):891-903. doi: 10.1097/ALN.0000000000005180.
PubMed 39102486
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plantar Compartment Block Versus Sciatic Block in Hallux Valgus Ambulatory Surgery : a Prospective, Randomised, Double Blind Study
- ClinicalTrials.gov ID
- NCT03922412
- Acronym / sponsor ID
- Plantar-block / RECHMPL18_0489
- Conditions
- Anesthesia
- Keywords
- Anesthesia, plantar Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 23 Nov 2022 (actual)
- Study completion
- 26 Nov 2022 (actual)
- First posted
- 22 Apr 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.
Sciatic popliteal 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.
This study aims to determine the quality of deambulation following hallux valgus surgery.
Block quality, post operative pain, patient satisfaction and length of hospital stay will be compared in this study.
Patients scheduled for ambulatory (hallux valgus) surgery under regional anaesthesia alone (without general anesthesia) will be recruited.
Consenting patients will be randomized the day of surgery to one of those two groups :
- Short lasting sciatic nerve block (mepivacaine 1% 200mg) and long lasting plantar block (ropivacaine 0,5% 25mg + 2mg dexamethasone) with distal deep peroneal block (ropivacaine 0,5% 2ml).
- Long lasting sciatic nerve block (ropivacaine 0,5% 100mg + 2mg dexamethasone)
All patients will benefit from post operative analgesia including paracetamol, nonsteroidal antiinflammatory drugs intravenously.
During PACU stay, pain will be assessed using the VAS (visual analogue scale) score, and analgesic IV consumption.
Temporospatial gait analysis will be assessed with a GAITRITE system before the patient leave the hospital.
Deambulation and walking ability will be evaluated at home postoperatively to day 3 using an acetimetry bracelet.
Pain, postoperative analgesic requirement, sleep quality and overall patient satisfaction (EVAN-LR) will also be assessed during the first 3 postoperative days.
Detailed description
Hallux valgus surgery is known as a painful surgery. Qualitative pain management is the key to successful early recovery and rehabilitation.
Sciatic popliteal 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.
This study aims to determine the quality of deambulation following hallux valgus surgery.
Block quality, post operative pain, patient satisfaction and length of hospital stay will be compared in this study.
Patients scheduled for ambulatory (hallux valgus) surgery under regional anaesthesia alone (without general anesthesia) will be recruited.
Consenting patients will be randomized the day of surgery to one of those two groups :
- Short lasting sciatic nerve block (mepivacaine 1% 200mg) and long lasting plantar block (ropivacaine 0,5% 25mg + 2mg dexamethasone) with distal deep peroneal block (ropivacaine 0,5% 2ml).
- Long lasting sciatic nerve block (ropivacaine 0,5% 100mg + 2mg dexamethasone)
All patients will benefit from post operative analgesia including paracetamol, nonsteroidal antiinflammatory drugs intravenously.
During PACU stay, pain will be assessed using the VAS (visual analogue scale) score, and analgesic IV consumption.
Temporospatial gait analysis will be assessed with a GAITRITE system before the patient leave the hospital (6 hours after ALR).
Deambulation and walking ability will be evaluated at home postoperatively to day 3 using an acetimetry bracelet.
Pain, postoperative analgesic requirement, sleep quality and overall patient satisfaction (EVAN-LR) will also be assessed during the first 3 postoperative days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| plantar block | Active comparator | Procedure: PLANTAR BLOCKShort lasting sciatic nerve block (mepivacaine 1% 200mg) and long lasting plantar block (ropivacaine 0,5% 25mg + 2mg dexamethasone) with distal deep peroneal block (ropivacaine 0,5% 2ml). |
| Sciatic popliteal block | Active comparator | Procedure: Sciatic popliteal blockLong lasting sciatic nerve block (ropivacaine 0,5% 100mg + 2mg dexamethasone) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| PLANTAR BLOCK1. Sciatic popliteal block : patient in lateral position, injection of 20 ml of the mixture labelled " BLOC POPLITE " containing 20 ml of mepivacain 1% (200mg) 2. Plantar block 10 minutes later : patient in supine position. Medial midfoot injection of 5 ml of the mixture labelled " BLOC PLANTAIRE " containing 5 ml of Ropivacaine 0,5% (25mg) with 0,5 ml dexaméthasone (2mg) 3. Distal deep fibular block : patient in supine position, injection around the dorsal foot artery of 2 ml of the mixture labelled " BLOC FIBULAIRE " containing 2 ml of Ropivacaine 0,5% (10mg). | Procedure or surgery | plantar block |
| Sciatic popliteal block1-Sciatic popliteal block : patient in lateral position, injection of 20 ml of the mixture labelled " BLOC POPLITE " containing 20 ml of ropivacaine 0,5% (100mg) with 2mg (0,5 ml) of dexamethasone | Procedure or surgery | Sciatic popliteal block |
Primary outcome
Number of steps walking ability assessed by GAITRITE Test
Time frame: 6 hours after ALR
Comparison of the deambulation assessed by GAITRITE test (walking test) between patient who received plantar block and patient who received sciatic popliteal block
6 secondary outcomes
Quantity of postoperative rescue analgesics taken
Time frame: up to 3 days after surgery
Assessment of the quality of the sensory blocks
Time frame: during the surgery
Assessment of the patient hospitalisation duration
Time frame: up to 3 days after surgery
Assessment of overall patient satisfaction assessed by the scale EVAN Loco regional
Time frame: up to 3 days after surgery
Assessment of sleep quality Assessment of patient sleep quality
Time frame: up to 3 days after surgery
Efficacity of patient walking ability
Time frame: up to 3 days after 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 2 Jun 2026.
- Results publication: PubMed 39102486Swisser F, Brethe Y, Choquet O, Herteleer M, Bernard N, Laffont I, Bringuier S, Capdevila X. Plantar Compartment Block Improves Enhanced Recovery after Hallux Valgus Surgery: A Randomized, Comparative, Double-blind Study. Anesthesiology. 2024 Nov 1;141(5):891-903. doi: 10.1097/ALN.0000000000005180.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PLANTAR BLOCK and Sciatic popliteal block in people with Anesthesia, 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 2 Jun 2026. 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?
Number of steps walking ability assessed by GAITRITE Test (time frame: 6 hours after ALR). 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 NCT03922412, 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 2 Jun 2026.