Anesthesia, LocalTEASERNCT05762159
Analgesic Territory Assessment of the Spinal Erector Block Using Pupillometry
An observational study of Anesthesia, Local, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Few works have studied the area of analgesia covered by the spinal erector block in an objective manner, especially on the cephalo-caudal spread. The available data are dissection works or subjective data such as thermoalgesic or epicritic sensitivity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- data collected
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2023to 7 May 2024
- Phase
- Observational
- 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
Study population: Patients receiving erector spinae block for pain management of spinal osteosynthesis will be included.
Who may be able to join
- Patients receiving erector spinae block for pain management of spinal osteosynthesis
Who cannot join
- Patient refusal
- Known allergy to local anesthetics
- Contraindication to locoregional anesthesia (haemostasis disorder, infection, peripheral neuropathy)
- Technical impossibility to perform a spinal erector block
- Pathology with dysautonomia altering the pupillary reflex: diabetes mellitus with diabetic retinopathy, multiple sclerosis, systemic amyloidosis, uncontrolled hypertension, glaucoma
- Current treatment likely to alter pupillary dilation reflex to pain : antiemetic (droperidol, metoclopramide), alpha-2 agonist (clonidine)
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- Serious psychiatric history
- Drug abuse
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Few works have studied the area of analgesia covered by the spinal erector block in an objective manner, especially on the cephalo-caudal spread. The available data are dissection works or subjective data such as thermoalgesic or epicritic sensitivity.
This information would however be relevant in order to propose a better analgesia. Indeed, it could explain certain failures by insufficient diffusion of the block. The use of a multistage block could be relevant, especially in the case of osteosynthesis on several vertebral levels.
Read the detailed description
Pupillometry makes possible to monitor analgesia based on the pupillary dilation reflex to pain. The goal is to establish an objective mapping of these type of analgesia from these data.
- Conditions
- Anesthesia, Local
- Being tested
- data collected
- Keywords
- spinal erector block, pupillometry, loco-regional anesthesia, osteosynthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectedOther
data collected:
- Morphological data of the patients
- Data of the erector block realization
- Pupillometric data :the variation of the pupil size on stimulation (in percentage of the base diameter)
| Study group | Role | What they receive |
|---|---|---|
| erector spinae block | Patients receiving erector spinae block for pain management of spinal osteosynthesis. Pupillometer will be realized during analgesia (usual practice). Receives: Other: data collected |
What is being measured
The primary outcome is the main question the study is designed to answer.
variation of the pupil size (in percentage)
Evaluation the territory covered by the spinal erector block by variation of the pupil size (in percentage).
Variation of the pupil size on stimulation will allow to deduce if the dermatome is covered by the spinal erector block analgesia.
Measured: During the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start10 Mar 2023
- Primary completion7 May 2024
- Study completion7 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxime Wodey, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762159
- Sponsor's protocol ID
- IRBN1272022/CHUSTE
- Acronym
- TEASER
- Status last verified
- May 2024
- First submitted
- 28 Feb 2023
- Last updated
- 21 May 2024
- 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 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Territory Assessment of the Spinal Erector Block Using Pupillometry
- ClinicalTrials.gov ID
- NCT05762159
- Acronym / sponsor ID
- TEASER / IRBN1272022/CHUSTE
- Conditions
- Anesthesia, Local
- Keywords
- spinal erector block, pupillometry, loco-regional anesthesia, osteosynthesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 7 May 2024 (actual)
- Study completion
- 7 May 2024 (actual)
- First posted
- 9 Mar 2023 (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.
Few works have studied the area of analgesia covered by the spinal erector block in an objective manner, especially on the cephalo-caudal spread. The available data are dissection works or subjective data such as thermoalgesic or epicritic sensitivity.
This information would however be relevant in order to propose a better analgesia. Indeed, it could explain certain failures by insufficient diffusion of the block. The use of a multistage block could be relevant, especially in the case of osteosynthesis on several vertebral levels.
Detailed description
Pupillometry makes possible to monitor analgesia based on the pupillary dilation reflex to pain. The goal is to establish an objective mapping of these type of analgesia from these data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| erector spinae block | – | Other: data collectedPatients receiving erector spinae block for pain management of spinal osteosynthesis. Pupillometer will be realized during analgesia (usual practice). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving erector spinae block for pain management of spinal osteosynthesis will be included.
Key inclusion criteria (1 listed)
- Patients receiving erector spinae block for pain management of spinal osteosynthesis
Key exclusion criteria (9 listed)
- Patient refusal
- Known allergy to local anesthetics
- Contraindication to locoregional anesthesia (haemostasis disorder, infection, peripheral neuropathy)
- Technical impossibility to perform a spinal erector block
- Pathology with dysautonomia altering the pupillary reflex: diabetes mellitus with diabetic retinopathy, multiple sclerosis, systemic amyloidosis, uncontrolled hypertension, glaucoma
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 |
|---|---|---|
| data collecteddata collected: * Morphological data of the patients * Data of the erector block realization * Pupillometric data :the variation of the pupil size on stimulation (in percentage of the base diameter) | Other | erector spinae block |
Primary outcome
variation of the pupil size (in percentage)
Time frame: During the surgery
Evaluation the territory covered by the spinal erector block by variation of the pupil size (in percentage). Variation of the pupil size on stimulation will allow to deduce if the dermatome is covered by the spinal erector block analgesia.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Individual participant dataSharing planned: No
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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.
Maxime Wodey, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, Local, run by Centre Hospitalier Universitaire de Saint Etienne 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 1 inclusion and 9 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: finished, as of the sponsor's last update on 21 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variation of the pupil size (in percentage) (time frame: During the surgery). 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 21 May 2024.