Vertebral Compression Fractures in Osteoporotic Patients
Conditions
Brief 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.
Interventions
OTHERanesthesia combined with intravenous analgesia by remifentanil
intravenous analgesia by remifentanil is provided and adapted to the patients' needs during the whole procedure
OTHERfluoroscopy-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
University Hospital, Strasbourg, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine used in the procedure | 1 day | Maximal target dose of remifentanil used during the procedure to obtain a satisfactory pain reduction during cement injection |
Countries
France
Contacts
Primary ContactThi Mai BERNEMANN, PI
Outcome results
None listed