Plantar Compartment Block in Hallux Valgus Ambulatory Sur... | NCT03815422

Studies
Plantar Compartment Block in Hallux Valgus Ambulatory Surgery

NCT03815422

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Mar 10, 2020Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Hallux Valgus Ambulatory Surgery

Interventions

Regional anesthesia

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2017Actual

Primary Completion Date

Dec 1, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Jan 21, 2019

First Submission Date that Met QC Criteria

Jan 23, 2019

First Posted Date

Jan 24, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2020

Last Update Posted Date

Mar 10, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Regional anesthesia	Procedure	Short lasting sciatic nerve block and long lasting plantar block with distal deep peroneal block

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Analgesia quality of the plantar compartment block	after Hallux Valgus ambulatory surgery	48 hours

Secondary Outcomes

Measure	Description	Time Frame
Quality of deambulation	48 hours	Quality of deambulation during the first 2 postoperative days.
postoperative analgesic	48 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with Plantar compartment block in Hallux Valgus ambulatory surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fabien SWISSER, MD	University Hospital, Montpellier	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uhmontpellier		Montpellier		34295	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38373818	Derived	Herteleer M, Choquet O, Swisser F, Bernard N, Gasc A, Canovas F, Dagneaux L, Bringuier S, Capdevila X. Plantar compartment block for hallux valgus surgery: a proof-of-concept anatomic and clinical study. Reg Anesth Pain Med. 2024 Feb 19:rapm-2023-105246. doi: 10.1136/rapm-2023-105246. Online ahead of print.

ID	Term
D000758	Anesthesia
D000760	Anesthesia and Analgesia