ClinicalTrials.Veeva

Menu

Interest of the Patient Management by Improved Recovery After Surgery in Percutaneous Vertebroplasty

G

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status

Completed

Conditions

Vertebral Compression

Treatments

Procedure: Vertebroplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT04453163
2020-A00600-39

Details and patient eligibility

About

This research aims to demonstrate the benefits of the RAAC program for patients undergoing cementoplasty, in particular on their level of anxiety and pain control throughout the perioperative phase.

Full description

The aim of the study is to compare the preoperative anxiety of patients hospitalized for a percutaneous vertebroplasty, depending on whether or not they are managed in an RAAC program.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥ 80 years or ≥ 18 years with oncological history;
  • Patient with vertebral compression fracture with indication for percutaneous vertebroplasty;
  • Patient seen in preoperative anesthesia / radiology consultation more than 4 days before the date of the vertebroplasty;
  • Having expressed their consent to participate in the study.

Exclusion criteria

  • Patient with a contraindication to percutaneous vertebroplasty, such as coagulation disorders, or an allergy or hypersensitivity to any of the products administered during the procedure;
  • Patient not affiliated to a social security scheme;
  • Patient participating in another clinical trial during the follow-up period;
  • Inability to understand information related to the study (linguistic, psychiatric, cognitive reason, etc.).

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

RAAC program
Experimental group
Description:
If the patient is under the "RAAC" group, he/she will then be received in consultation by a RAAC specialist nurse, between the anesthesia / radiology consultation and the intervention. This RAAC nurse will explain the procedure and show him/her an information video on vertebroplasty. Information about managing anxiety and pain will also be provided. In addition, the day after the patient leaves the clinic, the RAAC nurse will call him/her to inquire.
Treatment:
Procedure: Vertebroplasty
Standard management program
Other group
Description:
If the patient is under the "control" group, he/she will be taken care of according to the standard protocol after a surgery in percutaneous vertebroplasty. The patient will not have a consultation with the specialized nurse.
Treatment:
Procedure: Vertebroplasty

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems