Efficacy of Fluoroscopy-guided Epidural Anesthesia for Osteoporotic Vertebral Compression Fracture Treated by Percutaneous Vertebroplasty

Vertebral Compression Fractures in Osteoporotic Patients Clinical Trial

— VTB EPI-AL  

Official title:

Efficacy of Fluoroscopy-guided Epidural Anesthesia for Osteoporotic Vertebral Compression Fracture Treated by Percutaneous Vertebroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03621527
• Other study ID #: 6833
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2018
• Est. completion date: May 2019

Study information

• Verified date: June 2018
• Source: University Hospital, Strasbourg, France
• Contact: Thi Mai BERNEMANN, PI
• Phone: 03 69 55 16 23
• Email: thimai.bernemann[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Compression
• Vertebral Compression Fractures in Osteoporotic Patients

Intervention

Other:
• anesthesia combined with intravenous analgesia by remifentanil
intravenous analgesia by remifentanil is provided and adapted to the patients' needs during the whole procedure
• fluoroscopy-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

Locations

Country	Name	City	State
France	Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

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