Analgesic Territory Assessment of the Spinal Erector Block Using Pupillometry

Completed

• Conditions: Anesthesia, Local
• Interventions: Other: data collected

• Registration Number: NCT05762159
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Timeline

• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-02-28
• Study First Posted: 2023-03-09
• Study Start: 2023-03-10
• Status Verified: 2024-05
• Primary Completion: 2024-05-07
• Study Completion: 2024-05-07
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
variation of the pupil size (in percentage)	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.

Trial Locations

Locations (1)

CHU Saint-Etienne; 🇫🇷 Saint-Étienne, France