Vertebral Compression
Conditions
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.
Interventions
PROCEDUREVertebroplasty
Patient will undergo a surgery in percutaneous vertebroplasty
Sponsors
GCS Ramsay Santé pour l'Enseignement et la Recherche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Pain evaluation | 10 days | Evaluation of the pain on a numerical scale of 0 - no pain to 10 - maximum pain imaginable |
| 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) |
| 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. |
| Consumption of analgesics | 10 days | Evaluation of the consumption of analgesics expressed in mg of morphine equivalent. |
Countries
France
Outcome results
None listed