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OpenTrials
Completed

NCT Number: NCT04453163

Interest of the Patient Management by Improved Recovery After Surgery 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.

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Key information

Conditions

Vertebral Compression

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Belharra

Bayonne, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

vertebroplasty

Procedure

Patient will undergo a surgery in percutaneous vertebroplasty

Primary outcomes

  1. Superiority of Improved Recovery After Surgery versus standard management over preoperative anxiety

    Time frame: 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 outcomes

  1. Pain evaluation

    Time frame: 10 days

    Evaluation of the pain on a numerical scale of 0 - no pain to 10 - maximum pain imaginable

  2. Patient satisfaction

    Time frame: 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)

  3. Functional impotence

    Time frame: 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.

  4. Consumption of analgesics

    Time frame: 10 days

    Evaluation of the consumption of analgesics expressed in mg of morphine equivalent.

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 1, 2020
Registry last updated
Jan 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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