Plantar Compartment Block in Hallux Valgus Ambulatory Surgery (Observationnal)

March 9, 2020 updated by: University Hospital, Montpellier

Analgesia Quality and Quality of Deambulation of the Plantar Compartment Block After 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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Uhmontpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with Plantar compartment block in Hallux Valgus ambulatory surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Fabien SWISSER, MD, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2017

Primary Completion (ACTUAL)

December 1, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

January 21, 2019

First Submitted That Met QC Criteria

January 23, 2019

First Posted (ACTUAL)

January 24, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 10, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL18_0143

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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