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Spinal AnesthesiaTHERMOSYMPANCT05277220

Evaluation of the Recovery of the Sympathetic Block After Spinal Anesthesia by Thermographic Image

An observational study of Spinal Anesthesia, run by Central Hospital, Nancy, France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Spinal anesthesia is a locoregional perimedullary anesthesia which consists of temporary interruption of nerve transmission within the subarachnoid space. This anesthesia is produced, via a lumbar puncture, by injecting a solution of local anesthetics into cerebrospinal fluid. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spinal Anesthesia
What is being tested?
Thermal Camera Thermo Malin TC
Type of treatment
Medical device
How many people
63 participants
Where
No sites listed yet
Study dates
Mar 2022to Apr 2023
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: Adult patients, ASA (American Society of Anesthesiologists) score from I to 3 stabilized, who are going to have lower limb surgery under spinal anesthesia in outpatient surgery

Who may be able to join

  • Person who has received complete information on the organization of the research and has not opposed their participation and the use of their data
  • Adult patients,
  • ASA score from I to 3 stabilized
  • Outpatient orthopedic surgery of the lower limbs scheduled at the CCEG-Regional University Hospital Center of NANCY
  • Locoregional anesthesia by spinal anesthesia
  • Affiliation to a social security scheme or beneficiary of such a scheme

Who cannot join

  • Documented allergy to one of the agents injected intrathecally
  • Uncorrected absolute and / or relative hypovolaemia, as well as situations where the hemodynamics are not stabilized (state of shock, cardiac decompensation, etc.)
  • Obstructive heart disease (tight mitral stenosis, tight aortic stenosis, obstructive hypertrophic cardiomyopathy)
  • Arterial hypertension uncontrolled
  • Constrictive pericarditis
  • Obliterating arterial disease of the lower limbs
Show all 23Show fewer
  • Raynaud's syndrome
  • Localized infection near the puncture site and / or documented systemic infection
  • Infection of the lower limbs like erysipelas
  • Hemostatic disorder
  • Intracranial hypertension
  • Neurodegenerative diseases of the spinal cord
  • Congenital malformations (spina bifida)
  • Surgical emergency
  • Multi visceral failure
  • Conventional hospitalization
  • Persons referred to in Articles L. 1121-5 to L. 1121-8 and L1122-2 of the Public Health Code:
  • Pregnant woman, parturient or nursing mother
  • Person deprived of liberty by a judicial or administrative decision
  • Person unable to express their consent
  • Person undergoing psychiatric treatment under Articles L. 3212-1 and L. 3213-1 of the Public Health Code
  • Minor (not emancipated)
  • Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice)

Trial locations and contacts

No sites are listed yet.

HERVE BOUAZIZ, professor contact

03-83-85-15-31

h.bouaziz@chru-nancy.fr

ANAIS ROCHE, doctor contact

03.83.85.78.38

a.roche@chru-nancy.fr

About this study

Spinal anesthesia is a locoregional perimedullary anesthesia which consists of temporary interruption of nerve transmission within the subarachnoid space.

This anesthesia is produced, via a lumbar puncture, by injecting a solution of local anesthetics into cerebrospinal fluid.

Read more

Spinal anesthesia generates installation of three consecutive blocks: (i) a sympathetic block (vasodilation, increased skin heat in the sleeping area, arterial hypotension); (ii) a sensory block (i.e. a sensory paralysis: no pain or sensations at the incision), the level of which is assessed by the "touch" test and (iii) a motor block (a motor paralysis : immobility of the limb at the incision) measured by the Bromage score.

Spinal anesthesia is a common method of anesthesia in orthopedic surgery of the lower limbs, as demonstrated by field practice at the Surgical Center Emile Gallé (CCEG). This mode of anesthesia is an alternative to general anesthesia, especially because of a higher benefit / risk ratio. Patients at high-risk will be referred preferentially to a spinal anesthesia to prevent complications related to general anesthesia.

If the regulatory conditions are met (formalized expert recommendations 2009), some orthopedic procedures can be performed in the context of day hospitalization. The constraints of day hospitalization involve the use of anesthetic agents or doses compatible with a short duration of action equivalent to the duration of the act of surgery. They must allow a duration of action of maximum 4 hours, a predictable extension of the block at the T10 level (at the sensory level of the umbilicus), a short period of autonomy in ambulation, a rapid recovery from the dysfunction bladder and absence of hemodynamic effects. The return to normal motor function is the sine qua non of fitness for the street.

The discharge from the post-intervention monitoring room of a patient operated on under spinal anesthesia is validated once the recovery of the 3 blocks has been objectified : the motor block (bromage score), the sensory block (touch test) and the sympathetic block ( hemodynamic parameters).

One of the side effects associated with spinal anesthesia is the installation of a sympathetic block causing more or less significant hemodynamic variations. In current practice, its recovery is objectified when the hemodynamic parameters (FC, PNI) postoperatively (measured every 10 minutes) differ by less than 15% from the basic parameters pre-locoregional anesthesia (LRA). This evolution (with a threshold value of 15%) of the hemodynamic parameters constitutes the reference test (Gold Standard) to objectify a recovery of the sympathetic block. In reality, the criteria on which the recovery of the sympathetic block is based are imperfect because side effects (low blood pressure, nausea, vomiting) can be observed when returning to the outpatient surgery sector's, indicating the presence of a residual block.

Data from literature suggest that thermography would be an interesting alternative tool for evaluating the effectiveness of a nerve block after locoregional anesthesia (LRA). Installation of a nerve block is objectified by the change in temperature of the blocked body areas. In fact, the sympathetic block causes vasodilation in these areas and therefore an increase in local temperatures visible on thermography.

Concretely, performed before locoregional anesthesia (LRA), thermography gives a basal body mapping of local temperatures. These are the reference temperatures.

After performing locoregional anesthesia, the sympathetic block sets in and causes vasodilation which is itself responsible for an increase in local temperatures (appearance of warm colors on the body map). Then the return to the initial temperatures (i.e. those observed at the preoperative time) is done gradually as the sympathetic block recovers.

Use of the thermographic method to detect the recovery of sympathetic block after spinal anesthesia has never been evaluated. However, by comparison to these preoperative images, thermography could allow the detection of areas of local temperatures that are still high postoperatively (persistence of hot colors on the body map), while a return to basic local temperatures is expected. (neutral or cool colors).

This could alert to the persistence of a residual sympathetic block, with areas of the body where vasodilation persists despite the return to normal of hemodynamic parameters, and prevent complications in outpatient surgery sector's.

Main research hypothesis of the investigators is that thermographic image evaluation has very good sensitivity for the recovery of sympathetic block after spinal anesthesia compared to the reference method based on hemodynamic parameters. In addition, second research hypothesis of the investigators is that the recovery of the residual sympathetic block evaluated by thermographic image can reduce the occurrence of subsequent adverse events.

Read the detailed description

Main objective is the following:

To evaluate the performance of thermography to assess the state of total recovery of the sympathetic block after spinal anesthesia, the evolution of hemodynamic parameters constituting the reference examination.

Secondary objectives are:

  • Secondary objective 1: In patients with recovery of the sympathetic block objectified by the evolution of the hemodynamic parameters, compare the cumulative incidence of adverse events subsequent to the recovery of the sympathetic block according to the presence or not of a residual block determined by the thermographic evaluation .
  • Secondary objective 2: Evaluate the inter-observer agreement for the evaluation of the state of recovery of the block (2h30 after the spinal anesthesia) from the thermographic images.
  • Secondary objective 3: Describe nurses' responses to the acceptability survey for the use of thermography.
  • Secondary objective 4: Evaluate the diagnostic performance of temperature deltas to assess the state of total recovery of the sympathetic block after spinal anesthesia, the evolution of hemodynamic parameters constituting the reference examination.
Being tested
Thermal Camera Thermo Malin TC
Keywords
recovery of sympathetic block, thermographic image, outpatient surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thermal Camera Thermo Malin TCDevice

    Thermo Malin TC thermal camera (also called HIKVISION TP 31B portable thermal camera). Manufacturer of the researched product is HIKVISION.

    This thermal camera is equipped with a thermal detector with a resolution of 160 x 120 elements or an infrared resolution of 19,200 pixels.

    Thermal sensitivity of the Thermo Malin TC thermal imager is 40 milliKelvin (0.04 °C), with a spatial resolution of 5.48 mrad and a field of view of 37.2 x 50 °. Temperature accuracy at one point varies by +/- 0.5 °C. This thermal imager has four color palettes to highlight the desired elements.

    This camera is specially designed for measuring body temperature in a temperature range from +30 to + 45 °C.

    As part of the research, the thermal camera will enable the acquisition and recording of thermographic images at three times of study. These images are then transferred to the operating software for the Thermo Malin Series to process, analyze and make changes to elements of thermographic images.

Study groups in NCT05277220
Study groupRoleWhat they receive
ThermographyNot described
Receives: Device: Thermal Camera Thermo Malin TC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Performance of thermography in comparison with hemodynamic parameters (gold standard)

    Evaluation of the state of recovery of sympathetic block ("recovered" / "not recovered") from the thermographic images (before spinal anesthesia, 10 min after spinal anesthesia and 2h30 after spinal anesthesia)

    Measured: Baseline (J0) is the day when the spinal anesthesia is performed, up to 24 hours

Secondary outcomes (4)
  1. Cumulative incidence of each type of complications related to the persistence of a residual sympathetic block in outpatient surgery sector's

    The complications related to the persistence of a residual sympathetic block are: bradycardia, acute retention of urine, postoperative nausea and vomiting, orthostatic hypotension in outpatient surgery sector's.

    The state of total recovery of the block ("recovered" / "not recovered") will be determined by the thermographic evaluation.

    Measured: Baseline (J0) is the day when the spinal anesthesia is performed, up to 24 hours

  2. State of recovery of the block 2h30 after spinal anesthesia from the evaluation of thermographic images for each assessor

    The state of recovery ("recovered" / "not recovered") from the block to T2 (2h30 after spinal anesthesia) assessed by five evaluators.

    The investigators can thus compare the inter-observer agreement.

    Measured: Baseline (J0) is the day when the spinal anesthesia is performed, up to 24 hours

  3. Nurses' responses to the satisfaction questionnaire: acceptability survey for nurses at the Emile Gallé Surgical Center in relation to thermography

    The assessment of nurse anesthetists and operating room nurses on the use of thermography through an anonymous questionnaire.

    The questions will relate to their satisfaction ("satisfied" / "not satisfied"), the speed of use ("time-consuming" / "not time consuming"), the ease of use ("easy" / "difficult"), the frequency of malfunction ("not present" / "rare").

    Measured: Baseline (J0) is the day when the spinal anesthesia is performed, up to 24 hours

  4. Temperature deltas between T1 and T2

    Sensitivity (%), specificity (%), positive and negative predictive values (%) of temperature deltas (degrees Celsius).

    The temperature delta (degrees Celsius) between T1 and T2, corresponding to the magnitude of the difference between the "maximum" and "minimum" temperatures determined respectively at T1 and T2, will be determined from the evaluation of the thermographic images.

    Measured: Baseline (J0) is the day when the spinal anesthesia is performed, up to 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2022
  2. Study startMar 2022 (estimated)
  3. Primary completionFeb 2023 (estimated)
  4. Study completionApr 2023 (estimated)

Resources

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
63 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05277220
Sponsor's protocol ID
2021-A01606-35
Acronym
THERMOSYMPA
Status last verified
Mar 2022
First submitted
6 Dec 2021
Last updated
14 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Spinal Anesthesia, run by Central Hospital, Nancy, 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 6 inclusion and 23 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 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

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 HERVE BOUAZIZ, professor (03-83-85-15-31, h.bouaziz@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance of thermography in comparison with hemodynamic parameters (gold standard) (time frame: Baseline (J0) is the day when the spinal anesthesia is performed, up to 24 hours). 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 14 Mar 2022.

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