Vertebral Compression Fractures in Osteoporotic PatientsVTB EPI-ALNCT03621527
Efficacy of Fluoroscopy-guided Epidural Anesthesia for Osteoporotic Vertebral Compression Fracture Treated by Percutaneous Vertebroplasty
A study testing anesthesia combined with intravenous analgesia by remifentanil and fluoroscopy-guided epidural anesthesia in people with Vertebral Compression Fractures in Osteoporotic Patients, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertebral Compression Fractures in Osteoporotic Patients
- What is being tested?
- anesthesia combined with intravenous analgesia by remifentanil and fluoroscopy-guided epidural anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 3 May 2018to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000
Thi Mai BERNEMANN, PH
About this study
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.
Read more
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.
- Being tested
- anesthesia combined with intravenous analgesia by remifentanil, fluoroscopy-guided epidural anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anesthesia combined with intravenous analgesia by remifentanilOther
intravenous analgesia by remifentanil is provided and adapted to the patients' needs during the whole procedure
fluoroscopy-guided epidural anesthesiaOther
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
| Study group | Role | What they receive |
|---|---|---|
| Standard group | Active comparator | 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 Receives: Other: anesthesia combined with intravenous analgesia by remifentanil |
| Epidural group | Experimental | 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 Receives: Other: fluoroscopy-guided epidural anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine used in the procedure
Maximal target dose of remifentanil used during the procedure to obtain a satisfactory pain reduction during cement injection
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start3 May 2018
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral Compression Fractures in Osteoporotic PatientsStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thi Mai BERNEMANN, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621527
- Sponsor's protocol ID
- 6833
- Acronym
- VTB EPI-AL
- Status last verified
- Jun 2018
- First submitted
- 7 Jun 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Fluoroscopy-guided Epidural Anesthesia for Osteoporotic Vertebral Compression Fracture Treated by Percutaneous Vertebroplasty
- ClinicalTrials.gov ID
- NCT03621527
- Acronym / sponsor ID
- VTB EPI-AL / 6833
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 3 May 2018 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard group | Active comparator | Other: anesthesia combined with intravenous analgesia by remifentanilFor 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 | Experimental | Other: fluoroscopy-guided epidural anesthesiaFluoroscopy-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- - 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anesthesia combined with intravenous analgesia by remifentanilintravenous analgesia by remifentanil is provided and adapted to the patients' needs during the whole procedure | Other | Standard group |
| fluoroscopy-guided epidural anesthesiaIdentification 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 | Other | Epidural group |
Primary outcome
Morphine used in the procedure
Time frame: 1 day
Maximal target dose of remifentanil used during the procedure to obtain a satisfactory pain reduction during cement injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Vertebral Compression Fractures in Osteoporotic Patients
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Clinical Decision Support System
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thi Mai BERNEMANN principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anesthesia combined with intravenous analgesia by remifentanil and fluoroscopy-guided epidural anesthesia in people with Vertebral Compression Fractures in Osteoporotic Patients, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thi Mai BERNEMANN, PI (03 69 55 16 23 ext. +33, thimai.bernemann@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine used in the procedure (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.