Plantar Compartment Block Versus Sciatic Block in Hallux Valgus Ambulatory Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Plantar Compartment Block Versus Sciatic Block in Hallux Valgus Ambulatory Surgery : a Prospective, Randomised, Double Blind Study

Conditions
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Anesthesia

Intervention / Treatment
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* Procedure: PLANTAR BLOCK
* Procedure: Sciatic popliteal block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 75 years old patient covered by social health insurance have signed written informed consent scheduled for hallux valgus ambulatory surgery Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: plantar block<br>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). | Procedure: PLANTAR BLOCK<br>* 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).<br>|
| Active Comparator: Sciatic popliteal block<br>Long lasting sciatic nerve block (ropivacaine 0,5% 100mg + 2mg dexamethasone) | Procedure: Sciatic popliteal block<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 hours after ALR | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | during the surgery | 
| Assessment of the patient hospitalisation duration | Comparison of the duration of hospitalization between each group | 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 | 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 | 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 | up to 3 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, plantar Block