Intrathecal Chloroprocaine for Lower Limb Arthroplasty

May 3, 2022 updated by: Mikhail Dziadzko, MD, PhD, Hôpital de la Croix-Rousse

Perioperative Outcomes in Patients Received Spinal Chloroprocaine for Hip or Knee Arthroplasty

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study evaluates the failure rate of spinal anesthesia, the duration of surgical anesthesia, the needs for complementary intraoperative analgesia, the time for recovery, the incidence of urinary retention, postoperative nausea and vomiting, and length of stay in the recovery room in patients operated for knee or hip arthroplasty under spinal anesthesia with chloroprocaine 50 mg.

Study Type

Observational

Enrollment (Actual)

65

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
      • Lyon, France, 69004
        • Hôpital de la croix Rousse - Hospices Civils de Lyon

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • expressed disagreement to to participate after receiving information notice

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Spinal anesthesia with 50 mg of 1% Chloroprocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spinal anesthesia failure
Time Frame: Day 0
proportion of patients with the necessity to convert initially planned spinal anesthesia into general anesthesia
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemodynamic instability
Time Frame: Day 0
proportion of patients with >20% changes in blood pressure and ou heart rate comparing to baseline
Day 0
Need for sedation
Time Frame: Day 0
proportion of patients requiring intraoperative sedation for uncomfortable conditions
Day 0
Surgical block duration
Time Frame: Day 0
time of regression of sensitive and motor spinal block
Day 0
PACU analgesia requirement
Time Frame: Day 0
morphine equivalent requirement in PACU for the postoperative pain
Day 0
Urinary retention
Time Frame: 24 hours
proportion of patients requiring urinary catheter
24 hours
Postoperative nausea and vomiting
Time Frame: 24 hours
proportion of patients having nausea and vomiting
24 hours
Length of stay in recovery room
Time Frame: Day 0
Length of stay in recovery room
Day 0

Collaborators and Investigators

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

Sponsor

Hôpital de la Croix-Rousse

Collaborators

Hospices Civils de Lyon

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)

January 1, 2020

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

March 2, 2022

Study Registration Dates

First Submitted

April 18, 2022

First Submitted That Met QC Criteria

May 3, 2022

First Posted (Actual)

May 9, 2022

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSE-HCL 22_729

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

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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