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

NCT ID: NCT03621527

Last Updated: 2018-08-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-03
• Study Completion Date: 2019-05-31

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.

Conditions

Vertebral Compression Fractures in Osteoporotic Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Standard group

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

Group Type: ACTIVE_COMPARATOR

anesthesia combined with intravenous analgesia by remifentanil

Intervention Type: OTHER

intravenous analgesia by remifentanil is provided and adapted to the patients' needs during the whole procedure

Epidural group

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

Group Type: EXPERIMENTAL

fluoroscopy-guided epidural anesthesia

Intervention Type: OTHER

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

Interventions

anesthesia combined with intravenous analgesia by remifentanil

intravenous analgesia by remifentanil is provided and adapted to the patients' needs during the whole procedure

Intervention Type: OTHER

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thi Mai BERNEMANN

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires de Strasbourg

Locations

Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Thi Mai BERNEMANN, PI

Role: CONTACT

thimai.bernemann@chru-strasbourg.fr

03 69 55 16 23 ext. +33

Facility Contacts

Thi Mai BERNEMANN, PH

Role: primary

Other Identifiers

6833

Identifier Type: -

Identifier Source: org_study_id