Efficacy of Fluoroscopy-guided Epidural Anesthesia for Osteoporotic Vertebral Compression Fracture Treated by Percutaneous Vertebroplasty (VTB EPI-AL)

University Hospital, Strasbourg, France

Status: Unknown

Conditions: Vertebral Compression Fractures in Osteoporotic Patients

Treatments: Other: fluoroscopy-guided epidural anesthesia; Other: anesthesia combined with intravenous analgesia by remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT03621527

6833

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Standard group

Active Comparator group

Description:

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

Treatment:

Other: anesthesia combined with intravenous analgesia by remifentanil

Epidural group

Experimental group

Description:

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

Treatment:

Other: fluoroscopy-guided epidural anesthesia