Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
It is a monocentric, prospective, comparative and randomized study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard group | Active Comparator | 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 |
|
| Epidural group | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anesthesia combined with intravenous analgesia by remifentanil | Other | intravenous analgesia by remifentanil is provided and adapted to the patients' needs during the whole procedure |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thi Mai BERNEMANN, PI | Contact | 03 69 55 16 23 | +33 | thimai.bernemann@chru-strasbourg.fr |
| Name | Affiliation | Role |
|---|---|---|
| Thi Mai BERNEMANN | Hôpitaux Universitaires de Strasbourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Universitaires de Strasbourg | Recruiting | Strasbourg | 67000 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| fluoroscopy-guided epidural anesthesia | Other | 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 |
|