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Plantar Compartment Block Versus Sciatic Block in Hallux Valgus Ambulatory Surgery

Not Applicable
Completed
Conditions
Anesthesia
Interventions
Procedure: Sciatic popliteal block
Procedure: PLANTAR BLOCK
Registration Number
NCT03922412
Lead Sponsor
University Hospital, Montpellier
Brief 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.

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 :

1. 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).

2. 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 :

1. 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).

2. 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Sciatic popliteal blockSciatic popliteal blockLong lasting sciatic nerve block (ropivacaine 0,5% 100mg + 2mg dexamethasone)
plantar blockPLANTAR 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).
Primary Outcome Measures
NameTimeMethod
Number of steps walking ability assessed by GAITRITE Test6 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

Secondary Outcome Measures
NameTimeMethod
Assessment of the quality of the sensory blocksduring the surgery

Comparison of the sensory territories of anesthesia using cold between each group

Assessment of the patient hospitalisation durationup to 3 days after surgery

Comparison of the duration of hospitalization between each group

Assessment of overall patient satisfaction assessed by the scale EVAN Loco regionalup to 3 days after surgery

Comparison of overall patient satisfaction between each group

Efficacity of patient walking abilityup to 3 days after surgery

Comparison of the deambulation assessed by acetemeter between patient who received plantar block and patient who received sciatic popliteal block

Quantity of postoperative rescue analgesics takenup to 3 days after surgery

Comparison of the postoperative pain assessed by the Quantity of post-operative rescue analgesics between each group of patients

Assessment of sleep quality Assessment of patient sleep qualityup to 3 days after surgery

Comparison of patient sleep quality assessed by the somnifer consumption during the postoperative hospitalization between each group

Trial Locations

Locations (1)

UH Montpellier

🇫🇷

Montpellier, France

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