Plantar Compartment Block Versus Sciatic Block in Hallux Valgus Ambulatory Surgery

NCT03922412 | Completed

• 1 other identifier: RECHMPL18_0489
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 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. 2.Long lasting sciatic nerve block (ropivacaine 0,5% 100mg + 2mg dexamethasone)

Conditions

Anesthesia

Keywords

Anesthesia; plantar Block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Quantity of postoperative rescue analgesics taken

  up to 3 days after surgery

• Assessment of the quality of the sensory blocks

  during the surgery

• Assessment of the patient hospitalisation duration

  up to 3 days after surgery

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

  up to 3 days after surgery

• Assessment of sleep quality Assessment of patient sleep quality

  up to 3 days after surgery

Study Arms (2)

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).

Procedure: PLANTAR BLOCK

Sciatic popliteal block

ACTIVE COMPARATOR

Long lasting sciatic nerve block (ropivacaine 0,5% 100mg + 2mg dexamethasone)

Procedure: Sciatic popliteal block

Interventions

PLANTAR BLOCK PROCEDURE

1. 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).

plantar block

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

Sciatic popliteal block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years old
• patient covered by social health insurance
• have signed written informed consent
• scheduled for hallux valgus ambulatory surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

UH Montpellier

Montpellier, 34000, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: April 22, 2019
• Study Start: June 24, 2019
• Primary Completion: November 23, 2022
• Study Completion: November 26, 2022
• Last Updated: November 21, 2023

Record last verified: 2023-11

Locations

FR (1)