Analgesic Territory Assessment of the Spinal Erector Block Using Pupillometry

NCT ID: NCT05762159

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-10
• Study Completion Date: 2024-05-07

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

erector spinae block

Patients receiving erector spinae block for pain management of spinal osteosynthesis. Pupillometer will be realized during analgesia (usual practice).

data collected

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maxime Wodey, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

CHU Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

IRBN1272022/CHUSTE

Identifier Type: -

Identifier Source: org_study_id