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

Study Overview
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Brief Summary
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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.

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

Conditions
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Vertebral Compression Fractures in Osteoporotic Patients

Intervention / Treatment
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* Other: anesthesia combined with intravenous analgesia by remifentanil
* Other: fluoroscopy-guided epidural anesthesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard group<br>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 | Other: anesthesia combined with intravenous analgesia by remifentanil<br>* intravenous analgesia by remifentanil is provided and adapted to the patients' needs during the whole procedure<br>|
| Experimental: Epidural group<br>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 | Other: fluoroscopy-guided epidural anesthesia<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine used in the procedure | Maximal target dose of remifentanil used during the procedure to obtain a satisfactory pain reduction during cement injection | 1 day |