Vertebral Compression Clinical Trial
Official title:
Interest of Improved Recovery After Surgery (IRAS) Management [RAAC in French] in Percutaneous Vertebroplasty
Verified date | January 2023 |
Source | GCS Ramsay Santé pour l'Enseignement et la Recherche |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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.). |
Country | Name | City | State |
---|---|---|---|
France | Clinique Belharra | Bayonne |
Lead Sponsor | Collaborator |
---|---|
GCS Ramsay Santé pour l'Enseignement et la Recherche |
France,
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 |
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