Vertebral Compression Fractures in Osteoporotic Patients Clinical Trial
— VTB EPI-ALOfficial title:
Efficacy of Fluoroscopy-guided Epidural Anesthesia for Osteoporotic Vertebral Compression Fracture Treated by Percutaneous Vertebroplasty
NCT number | NCT03621527 |
Other study ID # | 6833 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 3, 2018 |
Est. completion date | May 2019 |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | May 2019 |
Est. primary completion date | May 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpitaux Universitaires de Strasbourg | Strasbourg |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Strasbourg, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |