Efficacy of Fluoroscopy-guided Epidural Anesthesia for Osteoporotic Vertebral Compression Fracture Treated by Percutaneous Vertebroplasty (VTB EPI-AL)
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.
Study Overview
Status
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Strasbourg, France, 67000
- Recruiting
- Hopitaux Universitaires de Strasbourg
-
Contact:
- Thi Mai BERNEMANN, PH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- - Two osteoporotic vertebra compression fractures in the low thoracic or lumbar spine
- men and women > 18 years old
- patients with healthcare insurance
- signed and dated informed consent
Exclusion Criteria:
- men and women < 18 years
- pregnant or breastfeeding women
- patients under trusteeship or guardianship or patients under the protection of court
- bad comprehension or cooperation
- bleeding disorders
- local or general infection
- intracerebral or severe cardiac affections
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard group
For each vertebra treated: 10 ml of lidocaine hydrochloride 1% are applied to the skin and the lower structures including the periosteum. An additional, anesthesia combined with intravenous analgesia by remifentanil is provided and adapted to the patients needs during the whole procedure |
intravenous analgesia by remifentanil is provided and adapted to the patients' needs during the whole procedure
|
|
Experimental: Epidural group
Fluoroscopy-guided epidural anesthesiaI is the identification of the epidural space using fluoroscopy and the injection of a small quantity of contrast medium or air. According to patient's height, 10-15 ml of lidocaine hydrochloride 1% are injected by the radiologist into the epidural space. An additional, anesthesia combined with intravenous analgesia by remifentanil is provided and adapted to the patients needs during the whole procedure |
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Morphine used in the procedure
Time Frame: 1 day
|
Maximal target dose of remifentanil used during the procedure to obtain a satisfactory pain reduction during cement injection
|
1 day
|
Collaborators and Investigators
Investigators
- Principal Investigator: Thi Mai BERNEMANN, Hopitaux Universitaires de Strasbourg
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6833
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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