Analgesic Territory Assessment of the Spinal Erector Block Using Pupillometry

Anesthesia, Local Clinical Trial

— TEASER  

Official title:

Analgesic Territory Assessment of the Spinal Erector Block Using Pupillometry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05762159
• Other study ID #: IRBN1272022/CHUSTE
• Status: Completed
• Start date: March 10, 2023
• Est. completion date: May 7, 2024

Study information

• Verified date: May 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 7, 2024
• Est. primary completion date: May 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients receiving erector spinae block for pain management of spinal osteosynthesis

Exclusion Criteria:

• 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)

• Serious psychiatric history

• Drug abuse

• Pregnancy

Related Conditions & MeSH terms

• Anesthesia, Local

Intervention

Other:
• data collected
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)

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During the surgery