Plantar Compartment Block Versus Sciatic Block in Hallux Valgus Ambulatory Surgery

Anesthesia Clinical Trial

— Plantar-block  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03922412
• Other study ID #: RECHMPL18_0489
• Status: Completed
• Phase: N/A
• Start date: June 24, 2019
• Est. completion date: November 26, 2022

Study information

• Verified date: November 2023
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 26, 2022
• Est. primary completion date: November 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Hallux Valgus

Intervention

Procedure:
• PLANTAR BLOCK
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
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

Locations

Country	Name	City	State
France	UH Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Assessment of the quality of the sensory blocks	Comparison of the sensory territories of anesthesia using cold between each group	during the surgery
Secondary	Assessment of the patient hospitalisation duration	Comparison of the duration of hospitalization between each group	up to 3 days after surgery
Secondary	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
Secondary	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
Secondary	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