An interventional study of anesthesia combined with intravenous analgesia by remifentanil and fluoroscopy-guided epidural anesthesia in Vertebral Compression Fractures in Osteoporotic Patients, sponsored by University Hospital, Strasbourg, France. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-08.
Sponsored by University Hospital, Strasbourg, France · Not applicable, Interventional, and Other
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.
50 studies on the registry are indexed under Fractures, Compression; 10 are open to participants now.
This study's planned enrollment of 100 is above the median of 73 across 32 interventional studies indexed under Fractures, Compression.
Browse Fractures, Compression studies →University Hospital, Strasbourg, France is the lead sponsor of 999 studies on the registry; 358 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Morphine used in the procedure
Maximal target dose of remifentanil used during the procedure to obtain a satisfactory pain reduction during cement injection
Time frame: 1 day
Plan to share: No
No publications or documents are linked to this record.
Started May 2018 (actual). Primary completion is estimated for May 2019, 12 months after the start.
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This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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University Hospital, Strasbourg, France →