Plantar Compartment Block in Hallux Valgus Ambulatory Surgery

Hallux Valgus Ambulatory Surgery Clinical Trial

— Observationnal  

Official title:

Analgesia Quality and Quality of Deambulation of the Plantar Compartment Block After Hallux Valgus Ambulatory Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03815422
• Other study ID #: RECHMPL18_0143
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Hallux valgus surgery is known as a painful surgery. Qualitative pain management is the key to successful early recovery and rehabilitation.

Popliteal sciatic 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.

The purpose of this study is to describe the analgesic effect of the plantar compartment block following hallux valgus surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

• preopérative gait disorders

• chronic kidney disease with glomerular filtration rate (GFR) = 50 ml/min (estimated by the Cockroft 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

• Bunion
• Hallux Valgus
• Hallux Valgus Ambulatory Surgery

Intervention

Procedure:
• Regional anesthesia
Short lasting sciatic nerve block and long lasting plantar block with distal deep peroneal block

Locations

Country	Name	City	State
France	Uhmontpellier	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	Analgesia quality of the plantar compartment block	after Hallux Valgus ambulatory surgery	48 hours
Secondary	Quality of deambulation	48 hours	Quality of deambulation during the first 2 postoperative days.
Secondary	postoperative analgesic	48 hours	postoperative analgesic requirement, during the first 2 postoperative days.