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

Not Applicable

Completed

• Conditions: Vertebral Compression
• Interventions: Procedure: Vertebroplasty

• Registration Number: NCT04453163
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-06-26
• Study First Submitted QC: 2020-06-26
• Study First Posted: 2020-07-01
• Study Start: 2020-11-17
• Primary Completion: 2022-12-19
• Study Completion: 2022-12-19
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-26
• Last Update Posted: 2023-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RAAC program	Vertebroplasty	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.
Standard management program	Vertebroplasty	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.

Primary Outcome Measures

Name	Time	Method
Superiority of Improved Recovery After Surgery versus standard management over preoperative anxiety	10 days	The main analysis consists of testing the superiority of Improved Recovery After Surgery versus standard management over preoperative anxiety, evaluated on a numerical scale of 0 to 10

Secondary Outcome Measures

Name	Time	Method
Pain evaluation	10 days	Evaluation of the pain on a numerical scale of 0 - no pain to 10 - maximum pain imaginable
Functional impotence	10 days	Evaluation of the functional impotence of low back pain by the Quebec score, which includes 20 questions on the ability to undertake daily activities, rated from 0 (no difficulty) to 5 (unable). The score therefore varies from 0 to 100.
Patient satisfaction	10 days	Evaluation of the patient satisfaction with care, assessed on a 5-level scale (not at all satisfied / somewhat dissatisfied / moderately satisfied / somewhat satisfied / very satisfied)
Consumption of analgesics	10 days	Evaluation of the consumption of analgesics expressed in mg of morphine equivalent.

Trial Locations

Locations (1)

Clinique Belharra; 🇫🇷 Bayonne, France