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

Not Applicable

• Conditions: Vertebral Compression Fractures in Osteoporotic Patients
• Interventions: Other: anesthesia combined with intravenous analgesia by remifentanil; Other: fluoroscopy-guided epidural anesthesia

• Registration Number: NCT03621527
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-03
• Status Verified: 2018-06
• Study First Submitted: 2018-06-07
• Study First Submitted QC: 2018-08-07
• Last Update Submitted: 2018-08-07
• Study First Posted: 2018-08-08
• Last Update Posted: 2018-08-08
• Primary Completion: 2019-05
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard group	anesthesia combined with intravenous analgesia by remifentanil	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
Epidural group	fluoroscopy-guided epidural anesthesia	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

Primary Outcome Measures

Name	Time	Method
Morphine used in the procedure	1 day	Maximal target dose of remifentanil used during the procedure to obtain a satisfactory pain reduction during cement injection

Trial Locations

Locations (1)

Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France