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

Interest of Improved Recovery After Surgery (IRAS) Management [RAAC in French] in Percutaneous Vertebroplasty

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.

Study Overview

• Status: Completed
• Conditions: Vertebral Compression
• Intervention / Treatment: Procedure: Vertebroplasty

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olivier MD BONNEFOY; Phone Number: 0536286464; Email: o.bonnefoy@cbim-radiologie.com

Study Locations

• France
  • Bayonne, France
    • Clinique Belharra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RAAC program; 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.	Procedure: Vertebroplasty; Patient will undergo a surgery in percutaneous vertebroplasty
Other: Standard management program; 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.	Procedure: Vertebroplasty; Patient will undergo a surgery in percutaneous vertebroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Superiority of Improved Recovery After Surgery versus standard management over preoperative anxiety	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	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain evaluation	Evaluation of the pain on a numerical scale of 0 - no pain to 10 - maximum pain imaginable	10 days
Patient satisfaction	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)	10 days
Functional impotence	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.	10 days
Consumption of analgesics	Evaluation of the consumption of analgesics expressed in mg of morphine equivalent.	10 days

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2020
• Primary Completion (Actual): December 19, 2022
• Study Completion (Actual): December 19, 2022

Study Registration Dates

• First Submitted: June 26, 2020
• First Submitted That Met QC Criteria: June 26, 2020
• First Posted (Actual): July 1, 2020

Study Record Updates

• Last Update Posted (Actual): January 27, 2023
• Last Update Submitted That Met QC Criteria: January 26, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2020-A00600-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No