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Efficacy of Fluoroscopy-guided Epidural Anesthesia for Osteoporotic Vertebral Compression Fracture Treated by Percutaneous Vertebroplasty

NCT03621527 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-08-08

No results posted yet for this study

Summary

Vertebral compression fractures in osteoporotic patients is a major healthcare problem. Percutaneous vertebroplasty is commonly used to restore stability of the vertebra and to alleviate pain. However, the anesthetic techniques commonly used during these procedures such general anesthesia or a combination of local anesthesia and sedation are not satisfying as they are associated either with side effects or insufficient pain reduction.

This study compares the standard procedure of local anesthesia to a new technique of fluoroscopy-guided epidural anesthesia carried out by the radiologist.

The investigator's hypothesis is that fluoroscopy-guided epidural anesthesia

* provides better pain relief during the injection of high viscosity cement
* and thus, reduces the need of additional intravenous analgesia by remifentanil (morphine analogue)
* minimizes remifentanil potential adverse effects such as respiratory depression, hypoxemia, pruritus and nausea
* improves working conditions and satisfaction of the radiologist
* improves the global satisfaction of the patient

It is a monocentric, prospective, comparative and randomized study.

Conditions

  • Vertebral Compression Fractures in Osteoporotic Patients

Interventions

OTHER

anesthesia combined with intravenous analgesia by remifentanil

intravenous analgesia by remifentanil is provided and adapted to the patients' needs during the whole procedure

OTHER

fluoroscopy-guided epidural anesthesia

Identification of the epidural space using fluoroscopy and the injection of a small quantity of contrast medium or air. An additional, anesthesia combined with intravenous analgesia by remifentanil is provided and adapted to the patients needs during the whole procedure

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    lead OTHER

Principal Investigators

  • Thi Mai BERNEMANN · Hôpitaux Universitaires de Strasbourg

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-03
Primary Completion
2019-05-31
Completion
2019-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03621527 on ClinicalTrials.gov