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NCT Number: NCT03922412

Plantar Compartment Block Versus Sciatic Block in 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.

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.

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Key information

Conditions

Anesthesia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UH Montpellier

Montpellier, 34000, France

About this 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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PLANTAR BLOCK

Procedure
  • 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 block

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Quantity of postoperative rescue analgesics taken

    Time frame: up to 3 days after surgery

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

  2. Assessment of the quality of the sensory blocks

    Time frame: during the surgery

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

  3. Assessment of the patient hospitalisation duration

    Time frame: up to 3 days after surgery

    Comparison of the duration of hospitalization between each group

  4. Assessment of overall patient satisfaction assessed by the scale EVAN Loco regional

    Time frame: up to 3 days after surgery

    Comparison of overall patient satisfaction between each group

  5. Assessment of sleep quality Assessment of patient sleep quality

    Time frame: up to 3 days after surgery

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

  6. Efficacity of patient walking ability

    Time frame: up 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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: Plantar-block

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 22, 2019
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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