NCT05365074

Brief Summary

This study evaluates the perioperative course in adult patients undergoing total or partial knee arthroplasty, or total hip arthroplasty under chloroprocaine spinal anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

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

January 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 9, 2022

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

2 years

First QC Date

April 18, 2022

Last Update Submit

May 3, 2022

Conditions

Lower Limb Arthroplasty Under Chloroprocaine Spinal Anesthesia

Keywords

chloroprocainetotal hip arthroplastytotal knee arthroplastyunicompartmental knee arthroplastyspinal anesthesia

Outcome Measures

Primary Outcomes (1)

  • Spinal anesthesia failure

    proportion of patients with the necessity to convert initially planned spinal anesthesia into general anesthesia

    Day 0

Secondary Outcomes (7)

  • Hemodynamic instability

    Day 0

  • Need for sedation

    Day 0

  • Surgical block duration

    Day 0

  • PACU analgesia requirement

    Day 0

  • Urinary retention

    24 hours

  • +2 more secondary outcomes

Study Arms (1)

chloroprocaine anesthesia for arthroplasty

patients having predicted uncomplicated surgery for total or unicompartment knee arthroplasty of anterior access total hip arthroplasty, operated under spinal anesthesia with 50 mg of chloroprocaine

Drug: Chloroprocaine Injection

Interventions

Chloroprocaine InjectionDRUG

Spinal anesthesia with 50 mg of 1% Chloroprocaine

chloroprocaine anesthesia for arthroplasty

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients operated for total knee, unicompartment knee or anterior access hip arthroplasty under chloroprocaine spinal anesthesia in the period of years 2020 - 2021

You may qualify if:

  • adult patients
  • with spinal anesthesia using 50 mg of chloroprocaine
  • operated for total knee, unicompartment knee or anterior access hip arthroplasty
  • in the period of years 2020 - 2021

You may not qualify if:

  • expressed disagreement to to participate after receiving information notice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital de la Croix Rousse - Hospices Civils de Lyon

Lyon, 69004, France

Location

MeSH Terms

Interventions

chloroprocaine

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior physician

Study Record Dates

First Submitted

April 18, 2022

First Posted

May 9, 2022

Study Start

January 1, 2020

Primary Completion

December 31, 2021

Study Completion

March 2, 2022

Last Updated

May 9, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

IPD are protected by the French regulation and will not be shared

Locations

FR(1)