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OpenTrials
Completed

NCT Number: NCT05762159

Analgesic Territory Assessment of the Spinal Erector Block Using Pupillometry

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Saint-Etienne

Saint-Etienne, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data collected

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)

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: TEASER

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 9, 2023
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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