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

Vertebral Compression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04453163
• Other study ID #: 2020-A00600-39
• Status: Completed
• Phase: N/A
• Start date: November 17, 2020
• Est. completion date: December 19, 2022

Study information

• Verified date: January 2023
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 19, 2022
• Est. primary completion date: December 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Vertebral Compression

Intervention

Procedure:
• Vertebroplasty
Patient will undergo a surgery in percutaneous vertebroplasty

Locations

Country	Name	City	State
France	Clinique Belharra	Bayonne

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain evaluation	Evaluation of the pain on a numerical scale of 0 - no pain to 10 - maximum pain imaginable	10 days
Secondary	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
Secondary	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
Secondary	Consumption of analgesics	Evaluation of the consumption of analgesics expressed in mg of morphine equivalent.	10 days