NCT03815422

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 24, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

January 21, 2019

Last Update Submit

March 9, 2020

Conditions

Keywords

Early ambulationPlantar block

Outcome Measures

Primary Outcomes (1)

  • Analgesia quality of the plantar compartment block

    after Hallux Valgus ambulatory surgery

    48 hours

Secondary Outcomes (2)

  • Quality of deambulation

    Quality of deambulation during the first 2 postoperative days.

  • postoperative analgesic

    postoperative analgesic requirement, during the first 2 postoperative days.

Interventions

Short lasting sciatic nerve block and long lasting plantar block with distal deep peroneal block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Plantar compartment block in Hallux Valgus ambulatory surgery

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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Anesthesia, Conduction

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • Fabien SWISSER, MD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2019

First Posted

January 24, 2019

Study Start

December 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 31, 2019

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations