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

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)

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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